Pediatrics

A recent increase in U.S. handgun ownership among white families tracks with a similar trend of recently rising gun deaths among young white children, a new study found. This association held even after adjustments for multiple sociodemographic variables that research previously had linked to higher gun ownership and higher firearm mortality.

Kateywhat/ThinkStock

“Indeed, firearm ownership, generally, was positively associated with firearm-related mortality among 1- to 5-year-old white children, but this correlation was primarily driven by changes in the proportion of families who owned handguns: firearms more often stored unsecured and loaded,” wrote Kate C. Prickett, PhD, of the Victoria University of Wellington (New Zealand) and her associates in Pediatrics.

“These findings suggest that ease of access and use may be an important consideration when examining firearm-related fatality risk among young children,” they continued. Given the lack of attenuation in the relationship from controlling for sociodemographic variables, they add, “this finding is in line with research documenting that the presence of a firearm in the home matters above and beyond other risk factors associated with child injury.”

Even though U.S. gun ownership and pediatric firearm mortality overall have been dropping over the past several decades, the latter has stagnated recently, and gun deaths among children aged 1-4 years nearly doubled between 2006-2016, the researchers noted.

Given the counterintuitive increase in young children’s gun deaths while overall gun ownership kept dropping, the researchers took a closer look at the relationship between gun deaths among children aged 1-5 years and specific types of firearm ownership among families with children under age 5 years in the home. They relied on household data from the nationally representative General Social Survey and on fatality statistics from the National Vital Statistics System from 1976-2016.

Over those 4 decades, gun ownership in white families with small children decreased from 50% to 45% and in black families with small children from 38% to 6%.

Simultaneously, however, handgun ownership increased from 25% to 32% among white families with young children. In fact, most firearm-owning white families (72%) owned a handgun in 2016 while rifle ownership had declined substantially.

Meanwhile, “firearm-related mortality rate among young white children declined from historic highs in the late 1970s to early 1980s until 2001,” the authors reported. “After 2004, however, the mortality rate began to rise, reaching mid-1980s levels.” Further, gun deaths constituted 2% of young children’s injury deaths in 1976 but nearly 5% in 2016.

When the researchers compared these findings, they found a positive, significant association between white child firearm mortality and the proportion of white families who owned a handgun but not a rifle or shotgun.

The association remained after the researchers adjusted for several covariates already established in the evidence base to have associations with firearm ownership, child injury risk and/or firearm mortality: living in a rural area, living in the South, neither parent having a college degree, and a household income in the bottom quartile nationally. In addition, “the annual national unemployment rate by race was included as an indicator of the broader economic context,” the authors wrote.

Although young black children die from guns nearly three times more frequently than white children, the authors were unable to present detailed findings on associations with gun ownership because of small sample sizes. They noted, however, that handgun ownership actually declined during the study period from 15% to 6% in black families with young children.

The researchers concluded that the recent increase in young children’s gun deaths may be partly driven by an increase in handgun ownership, even as overall gun ownership (primarily rifles and shotguns) has continued dropping.

“For young children, shootings are more likely to be unintentional, making the ease at which firearms can be accessed and used a more important determinant of mortality than perhaps for older children,” the authors wrote. “Moreover, relative to other firearms like hunting rifles, handguns, because they are more likely to be purchased for personal protection, are more likely to be stored loaded with ammunition, unlocked, and in a more easily accessible place, such as a bedroom drawer.”

The research was funded by the National Institute of Child Health and Human Development. The authors reported having no conflicts of interest.

SOURCE: Prickett KC et al. Pediatrics. 2019;143(2):e20181171.

A recent increase in U.S. handgun ownership among white families tracks with a similar trend of recently rising gun deaths among young white children, a new study found. This association held even after adjustments for multiple sociodemographic variables that research previously had linked to higher gun ownership and higher firearm mortality.

Kateywhat/ThinkStock

“Indeed, firearm ownership, generally, was positively associated with firearm-related mortality among 1- to 5-year-old white children, but this correlation was primarily driven by changes in the proportion of families who owned handguns: firearms more often stored unsecured and loaded,” wrote Kate C. Prickett, PhD, of the Victoria University of Wellington (New Zealand) and her associates in Pediatrics.

“These findings suggest that ease of access and use may be an important consideration when examining firearm-related fatality risk among young children,” they continued. Given the lack of attenuation in the relationship from controlling for sociodemographic variables, they add, “this finding is in line with research documenting that the presence of a firearm in the home matters above and beyond other risk factors associated with child injury.”

Even though U.S. gun ownership and pediatric firearm mortality overall have been dropping over the past several decades, the latter has stagnated recently, and gun deaths among children aged 1-4 years nearly doubled between 2006-2016, the researchers noted.

Given the counterintuitive increase in young children’s gun deaths while overall gun ownership kept dropping, the researchers took a closer look at the relationship between gun deaths among children aged 1-5 years and specific types of firearm ownership among families with children under age 5 years in the home. They relied on household data from the nationally representative General Social Survey and on fatality statistics from the National Vital Statistics System from 1976-2016.

Over those 4 decades, gun ownership in white families with small children decreased from 50% to 45% and in black families with small children from 38% to 6%.

Simultaneously, however, handgun ownership increased from 25% to 32% among white families with young children. In fact, most firearm-owning white families (72%) owned a handgun in 2016 while rifle ownership had declined substantially.

Meanwhile, “firearm-related mortality rate among young white children declined from historic highs in the late 1970s to early 1980s until 2001,” the authors reported. “After 2004, however, the mortality rate began to rise, reaching mid-1980s levels.” Further, gun deaths constituted 2% of young children’s injury deaths in 1976 but nearly 5% in 2016.

When the researchers compared these findings, they found a positive, significant association between white child firearm mortality and the proportion of white families who owned a handgun but not a rifle or shotgun.

The association remained after the researchers adjusted for several covariates already established in the evidence base to have associations with firearm ownership, child injury risk and/or firearm mortality: living in a rural area, living in the South, neither parent having a college degree, and a household income in the bottom quartile nationally. In addition, “the annual national unemployment rate by race was included as an indicator of the broader economic context,” the authors wrote.

Although young black children die from guns nearly three times more frequently than white children, the authors were unable to present detailed findings on associations with gun ownership because of small sample sizes. They noted, however, that handgun ownership actually declined during the study period from 15% to 6% in black families with young children.

The researchers concluded that the recent increase in young children’s gun deaths may be partly driven by an increase in handgun ownership, even as overall gun ownership (primarily rifles and shotguns) has continued dropping.

“For young children, shootings are more likely to be unintentional, making the ease at which firearms can be accessed and used a more important determinant of mortality than perhaps for older children,” the authors wrote. “Moreover, relative to other firearms like hunting rifles, handguns, because they are more likely to be purchased for personal protection, are more likely to be stored loaded with ammunition, unlocked, and in a more easily accessible place, such as a bedroom drawer.”

The research was funded by the National Institute of Child Health and Human Development. The authors reported having no conflicts of interest.

SOURCE: Prickett KC et al. Pediatrics. 2019;143(2):e20181171.

A recent increase in U.S. handgun ownership among white families tracks with a similar trend of recently rising gun deaths among young white children, a new study found. This association held even after adjustments for multiple sociodemographic variables that research previously had linked to higher gun ownership and higher firearm mortality.

Kateywhat/ThinkStock

“Indeed, firearm ownership, generally, was positively associated with firearm-related mortality among 1- to 5-year-old white children, but this correlation was primarily driven by changes in the proportion of families who owned handguns: firearms more often stored unsecured and loaded,” wrote Kate C. Prickett, PhD, of the Victoria University of Wellington (New Zealand) and her associates in Pediatrics.

“These findings suggest that ease of access and use may be an important consideration when examining firearm-related fatality risk among young children,” they continued. Given the lack of attenuation in the relationship from controlling for sociodemographic variables, they add, “this finding is in line with research documenting that the presence of a firearm in the home matters above and beyond other risk factors associated with child injury.”

Even though U.S. gun ownership and pediatric firearm mortality overall have been dropping over the past several decades, the latter has stagnated recently, and gun deaths among children aged 1-4 years nearly doubled between 2006-2016, the researchers noted.

Given the counterintuitive increase in young children’s gun deaths while overall gun ownership kept dropping, the researchers took a closer look at the relationship between gun deaths among children aged 1-5 years and specific types of firearm ownership among families with children under age 5 years in the home. They relied on household data from the nationally representative General Social Survey and on fatality statistics from the National Vital Statistics System from 1976-2016.

Over those 4 decades, gun ownership in white families with small children decreased from 50% to 45% and in black families with small children from 38% to 6%.

Simultaneously, however, handgun ownership increased from 25% to 32% among white families with young children. In fact, most firearm-owning white families (72%) owned a handgun in 2016 while rifle ownership had declined substantially.

Meanwhile, “firearm-related mortality rate among young white children declined from historic highs in the late 1970s to early 1980s until 2001,” the authors reported. “After 2004, however, the mortality rate began to rise, reaching mid-1980s levels.” Further, gun deaths constituted 2% of young children’s injury deaths in 1976 but nearly 5% in 2016.

When the researchers compared these findings, they found a positive, significant association between white child firearm mortality and the proportion of white families who owned a handgun but not a rifle or shotgun.

The association remained after the researchers adjusted for several covariates already established in the evidence base to have associations with firearm ownership, child injury risk and/or firearm mortality: living in a rural area, living in the South, neither parent having a college degree, and a household income in the bottom quartile nationally. In addition, “the annual national unemployment rate by race was included as an indicator of the broader economic context,” the authors wrote.

Although young black children die from guns nearly three times more frequently than white children, the authors were unable to present detailed findings on associations with gun ownership because of small sample sizes. They noted, however, that handgun ownership actually declined during the study period from 15% to 6% in black families with young children.

The researchers concluded that the recent increase in young children’s gun deaths may be partly driven by an increase in handgun ownership, even as overall gun ownership (primarily rifles and shotguns) has continued dropping.

“For young children, shootings are more likely to be unintentional, making the ease at which firearms can be accessed and used a more important determinant of mortality than perhaps for older children,” the authors wrote. “Moreover, relative to other firearms like hunting rifles, handguns, because they are more likely to be purchased for personal protection, are more likely to be stored loaded with ammunition, unlocked, and in a more easily accessible place, such as a bedroom drawer.”

The research was funded by the National Institute of Child Health and Human Development. The authors reported having no conflicts of interest.

SOURCE: Prickett KC et al. Pediatrics. 2019;143(2):e20181171.

THE CASE

A healthy 6-month-old girl born via spontaneous vaginal delivery to a 33-year-old mother presented to her family physician (FP) for a routine well-child examination. The mother’s prenatal anatomy scan, delivery, and personal and family history were unremarkable. The patient was not firstborn or breech, and there was no family history of hip dysplasia. On prior infant well-child examinations, Ortolani and Barlow maneuvers were negative, and the patient demonstrated spontaneous movement of both legs. There was no evidence of hip dysplasia, lower extremity weakness, musculoskeletal abnormalities, or abnormal skin markings. The patient had normal growth and development (50th percentile for height and weight, average Ages & Stages Questionnaire scores) and no history of infection or trauma.

At the current presentation, the FP noted a leg-length discrepancy while palpating the bony (patellar and malleolar) landmarks of the lower extremities, but the right and left anterior superior iliac spine was symmetrical. The gluteal folds and popliteal fossae were asymmetric, a Galeazzi test was positive, and the right leg measured approximately 2 cm shorter than the left leg. There was no evidence of scoliosis or pelvic abnormalities. Physical examination revealed no ecchymosis or trauma. Orthopedic evaluation by the FP of the hips, knees, and ankles was normal, including negative repeat Ortolani and Barlow maneuvers and normal range of motion. We obtained x-rays of the lower extremities and ordered an orthopedic consultation.

THE DIAGNOSIS

The differential diagnosis included congenital, traumatic, infectious, inflammatory, idiopathic, and neurologic causes.^1-3 The most common etiologies of leg-length discrepancies are summarized in TABLE 1.^1-3 Radiographic imaging showed a femur length discrepancy, which was determined to be congenital without indication of trauma or disease; therefore, a diagnosis of congenital femoral bowing was made.

Initial orthopedic evaluation revealed a femur length discrepancy of approximately 2 cm. Plain films showed lateral femoral bowing (FIGURE 1A). Regular interval imaging performed at routine well-child examinations at 19 months, 3 years, and 5 years of age showed progression of the femoral length discrepancy from 2 cm to nearly 5 cm, remaining proportionally constant, as well as increasing genu valgum of the right leg up to 12 degrees (FIGURE 1B-D).

DISCUSSION

Congenital femoral bowing, which can present as a leg-length discrepancy in infants, is a relatively rare finding with an incidence of 1 per 52,000 births.⁴ Our patient presented with an isolated limb deformity, but congenital femoral bowing is recognized as a clinical feature of several skeletal dysplasias (TABLE 2).⁵

What’s recommended

The American Academy of Pediatrics recommends routine age-appropriate physical examination without specifying leg-length assessment.⁶ There is insufficient evidence, according to the US Preventive Services Task Force and the American Academy of Pediatrics, regarding the value of routine infant hip and leg-length assessment for developmental dysplasia of the hip and other musculoskeletal abnormalities; however, both agree that abnormal findings require follow-up and management.^6-8

Congenital femoral bowing requires plain film diagnosis

Following physical examination, diagnosis of congenital femoral bowing should be confirmed by plain films. Plain radiography remains the main imaging modality for proximal focal femoral deficiency and fibular hemimelia, and appropriate identification of the osseous abnormalities seen on radiographs allows for accurate classification of congenital femoral bowing, prognosis, and surgical planning. (Minor malformations associated with congenital leg-length discrepancies are not typically identified as being part of a larger syndromic diagnosis.⁴) The patient should subsequently be referred to an orthopedist for monitoring and to establish a long-term management plan.

Continue to: Early diagnosis can improve treatment outcome

Early diagnosis can improve treatment outcome

Both early diagnosis of congenital femoral bowing and prediction of leg-length discrepancy at skeletal maturity can influence potential treatment options, which range from conservative management (eg, watchful waiting, physical therapy, shoe lifts, orthotics, bracing) to surgical intervention. Several models have been used to predict skeletal growth, including the Moseley straight line graph, Green and Anderson growth curve, Amstutz method, and Paley’s multiplier method.^4,9-14

Congenital femoral bowing may present clinically as a leg-length discrepancy with no indication of trauma or disease.

Intervention for leg-length discrepancy generally is dictated by the magnitude of the inequality and the presence of functional deficits and/or pain.² If the degree of femur angulation begins to affect structural development, surgical intervention should be considered to align development and/or correct the discrepancy. Physical therapy, shoe lifts, orthotics, and bracing are treatment options for managing smaller discrepancies.^2,15

Our patient. The physician (CP) reviewed treatment options with the family that included watchful waiting, use of a shoe lift and/or orthotics, and bracing. The family chose watchful waiting due to the structural integrity of the patient’s other major joints and her relatively preserved function. The patient demonstrated mild gross motor delay at routine well-child visits at 9, 12, and 15 months, but was walking by 19 months. Her development was otherwise normal as documented via regular developmental screenings at routine well-child examinations. The patient participated in home physical therapy to maintain strength, flexibility, and functional mobility, and she was able to ambulate by walking on her right toes.

Surgery. Ultimately the patient underwent medial distal femoral hemiepiphysiodesis of the right lower extremity at 6 years of age due to increasing leg-length discrepancy and lateralization of the patella from the valgus deformity. The patient’s mother reported that she did well postoperatively, with increased range of motion, improved physical capabilities, and reduced discomfort in the right leg. She continued to participate in physical therapy and had routine follow-up with her physical therapist, her FP, and orthopedist.

A second surgery. At approximately 8 years and 9 months of age, the orthopedist noted that the patient’s leg-length discrepancy had increased, and she had right extensor mechanism malalignment and severe patellar subluxation. The patient subsequently underwent surgery to remove the existing hardware, including right extensor mechanism realignment via a Roux-Goldthwait procedure (with reconstruction of the medial patellofemoral ligament and anterior cruciate ligament), as well as left distal femoral epiphysiodesis. She did very well postoperatively and continues to participate in physical therapy approximately once weekly. She has had an improvement in her gait and stability using shoe lifts.

Continue to: THE TAKEAWAY

 

 

THE TAKEAWAY

A routine well-child examination can be an opportunity to identify congenital musculoskeletal problems. Congenital femoral bowing is a relatively rare finding⁴ that may present as a leg-length discrepancy. With proper evaluation, including visual inspection, palpation, range-of-motion testing, and special tests as needed (eg, Galeazzi test, Ortolani and Barlow maneuvers), early intervention is possible if a leg-length discrepancy is noted. Close monitoring of gait abnormalities at routine well-child visits is essential.

Physical therapy, shoe lift therapy, and surgical approaches are treatment options for leg-length discrepancy,² and early intervention can improve treatment outcomes.¹⁴ Understanding how to manage congenital femoral bowing over time is important in providing options and counselling patients and their families.¹⁵

Treatment of leg-length discrepancy in pediatric patients requires long-term management with a team approach that includes patients and their families. The goal of intervention is to reduce physical and emotional trauma, while addressing complications and maintaining function of the affected limb, as well as the whole body.¹⁵

CORRESPONDENCE
Beth P. Davis, DPT, MBA, FNAP, Emory University School of Medicine, Department of Rehabilitation Medicine, Division of Physical Therapy, 1462 Clifton Road NE, Suite 312, Atlanta, GA 30342; bethpdavis@emory.edu.

THE CASE

A healthy 6-month-old girl born via spontaneous vaginal delivery to a 33-year-old mother presented to her family physician (FP) for a routine well-child examination. The mother’s prenatal anatomy scan, delivery, and personal and family history were unremarkable. The patient was not firstborn or breech, and there was no family history of hip dysplasia. On prior infant well-child examinations, Ortolani and Barlow maneuvers were negative, and the patient demonstrated spontaneous movement of both legs. There was no evidence of hip dysplasia, lower extremity weakness, musculoskeletal abnormalities, or abnormal skin markings. The patient had normal growth and development (50th percentile for height and weight, average Ages & Stages Questionnaire scores) and no history of infection or trauma.

At the current presentation, the FP noted a leg-length discrepancy while palpating the bony (patellar and malleolar) landmarks of the lower extremities, but the right and left anterior superior iliac spine was symmetrical. The gluteal folds and popliteal fossae were asymmetric, a Galeazzi test was positive, and the right leg measured approximately 2 cm shorter than the left leg. There was no evidence of scoliosis or pelvic abnormalities. Physical examination revealed no ecchymosis or trauma. Orthopedic evaluation by the FP of the hips, knees, and ankles was normal, including negative repeat Ortolani and Barlow maneuvers and normal range of motion. We obtained x-rays of the lower extremities and ordered an orthopedic consultation.

THE DIAGNOSIS

The differential diagnosis included congenital, traumatic, infectious, inflammatory, idiopathic, and neurologic causes.^1-3 The most common etiologies of leg-length discrepancies are summarized in TABLE 1.^1-3 Radiographic imaging showed a femur length discrepancy, which was determined to be congenital without indication of trauma or disease; therefore, a diagnosis of congenital femoral bowing was made.

Initial orthopedic evaluation revealed a femur length discrepancy of approximately 2 cm. Plain films showed lateral femoral bowing (FIGURE 1A). Regular interval imaging performed at routine well-child examinations at 19 months, 3 years, and 5 years of age showed progression of the femoral length discrepancy from 2 cm to nearly 5 cm, remaining proportionally constant, as well as increasing genu valgum of the right leg up to 12 degrees (FIGURE 1B-D).

DISCUSSION

Congenital femoral bowing, which can present as a leg-length discrepancy in infants, is a relatively rare finding with an incidence of 1 per 52,000 births.⁴ Our patient presented with an isolated limb deformity, but congenital femoral bowing is recognized as a clinical feature of several skeletal dysplasias (TABLE 2).⁵

What’s recommended

The American Academy of Pediatrics recommends routine age-appropriate physical examination without specifying leg-length assessment.⁶ There is insufficient evidence, according to the US Preventive Services Task Force and the American Academy of Pediatrics, regarding the value of routine infant hip and leg-length assessment for developmental dysplasia of the hip and other musculoskeletal abnormalities; however, both agree that abnormal findings require follow-up and management.^6-8

Congenital femoral bowing requires plain film diagnosis

Following physical examination, diagnosis of congenital femoral bowing should be confirmed by plain films. Plain radiography remains the main imaging modality for proximal focal femoral deficiency and fibular hemimelia, and appropriate identification of the osseous abnormalities seen on radiographs allows for accurate classification of congenital femoral bowing, prognosis, and surgical planning. (Minor malformations associated with congenital leg-length discrepancies are not typically identified as being part of a larger syndromic diagnosis.⁴) The patient should subsequently be referred to an orthopedist for monitoring and to establish a long-term management plan.

Continue to: Early diagnosis can improve treatment outcome

Early diagnosis can improve treatment outcome

Both early diagnosis of congenital femoral bowing and prediction of leg-length discrepancy at skeletal maturity can influence potential treatment options, which range from conservative management (eg, watchful waiting, physical therapy, shoe lifts, orthotics, bracing) to surgical intervention. Several models have been used to predict skeletal growth, including the Moseley straight line graph, Green and Anderson growth curve, Amstutz method, and Paley’s multiplier method.^4,9-14

Congenital femoral bowing may present clinically as a leg-length discrepancy with no indication of trauma or disease.

Intervention for leg-length discrepancy generally is dictated by the magnitude of the inequality and the presence of functional deficits and/or pain.² If the degree of femur angulation begins to affect structural development, surgical intervention should be considered to align development and/or correct the discrepancy. Physical therapy, shoe lifts, orthotics, and bracing are treatment options for managing smaller discrepancies.^2,15

Our patient. The physician (CP) reviewed treatment options with the family that included watchful waiting, use of a shoe lift and/or orthotics, and bracing. The family chose watchful waiting due to the structural integrity of the patient’s other major joints and her relatively preserved function. The patient demonstrated mild gross motor delay at routine well-child visits at 9, 12, and 15 months, but was walking by 19 months. Her development was otherwise normal as documented via regular developmental screenings at routine well-child examinations. The patient participated in home physical therapy to maintain strength, flexibility, and functional mobility, and she was able to ambulate by walking on her right toes.

Surgery. Ultimately the patient underwent medial distal femoral hemiepiphysiodesis of the right lower extremity at 6 years of age due to increasing leg-length discrepancy and lateralization of the patella from the valgus deformity. The patient’s mother reported that she did well postoperatively, with increased range of motion, improved physical capabilities, and reduced discomfort in the right leg. She continued to participate in physical therapy and had routine follow-up with her physical therapist, her FP, and orthopedist.

A second surgery. At approximately 8 years and 9 months of age, the orthopedist noted that the patient’s leg-length discrepancy had increased, and she had right extensor mechanism malalignment and severe patellar subluxation. The patient subsequently underwent surgery to remove the existing hardware, including right extensor mechanism realignment via a Roux-Goldthwait procedure (with reconstruction of the medial patellofemoral ligament and anterior cruciate ligament), as well as left distal femoral epiphysiodesis. She did very well postoperatively and continues to participate in physical therapy approximately once weekly. She has had an improvement in her gait and stability using shoe lifts.

Continue to: THE TAKEAWAY

 

 

THE TAKEAWAY

A routine well-child examination can be an opportunity to identify congenital musculoskeletal problems. Congenital femoral bowing is a relatively rare finding⁴ that may present as a leg-length discrepancy. With proper evaluation, including visual inspection, palpation, range-of-motion testing, and special tests as needed (eg, Galeazzi test, Ortolani and Barlow maneuvers), early intervention is possible if a leg-length discrepancy is noted. Close monitoring of gait abnormalities at routine well-child visits is essential.

Physical therapy, shoe lift therapy, and surgical approaches are treatment options for leg-length discrepancy,² and early intervention can improve treatment outcomes.¹⁴ Understanding how to manage congenital femoral bowing over time is important in providing options and counselling patients and their families.¹⁵

Treatment of leg-length discrepancy in pediatric patients requires long-term management with a team approach that includes patients and their families. The goal of intervention is to reduce physical and emotional trauma, while addressing complications and maintaining function of the affected limb, as well as the whole body.¹⁵

CORRESPONDENCE
Beth P. Davis, DPT, MBA, FNAP, Emory University School of Medicine, Department of Rehabilitation Medicine, Division of Physical Therapy, 1462 Clifton Road NE, Suite 312, Atlanta, GA 30342; bethpdavis@emory.edu.

THE CASE

A healthy 6-month-old girl born via spontaneous vaginal delivery to a 33-year-old mother presented to her family physician (FP) for a routine well-child examination. The mother’s prenatal anatomy scan, delivery, and personal and family history were unremarkable. The patient was not firstborn or breech, and there was no family history of hip dysplasia. On prior infant well-child examinations, Ortolani and Barlow maneuvers were negative, and the patient demonstrated spontaneous movement of both legs. There was no evidence of hip dysplasia, lower extremity weakness, musculoskeletal abnormalities, or abnormal skin markings. The patient had normal growth and development (50th percentile for height and weight, average Ages & Stages Questionnaire scores) and no history of infection or trauma.

At the current presentation, the FP noted a leg-length discrepancy while palpating the bony (patellar and malleolar) landmarks of the lower extremities, but the right and left anterior superior iliac spine was symmetrical. The gluteal folds and popliteal fossae were asymmetric, a Galeazzi test was positive, and the right leg measured approximately 2 cm shorter than the left leg. There was no evidence of scoliosis or pelvic abnormalities. Physical examination revealed no ecchymosis or trauma. Orthopedic evaluation by the FP of the hips, knees, and ankles was normal, including negative repeat Ortolani and Barlow maneuvers and normal range of motion. We obtained x-rays of the lower extremities and ordered an orthopedic consultation.

THE DIAGNOSIS

The differential diagnosis included congenital, traumatic, infectious, inflammatory, idiopathic, and neurologic causes.^1-3 The most common etiologies of leg-length discrepancies are summarized in TABLE 1.^1-3 Radiographic imaging showed a femur length discrepancy, which was determined to be congenital without indication of trauma or disease; therefore, a diagnosis of congenital femoral bowing was made.

Initial orthopedic evaluation revealed a femur length discrepancy of approximately 2 cm. Plain films showed lateral femoral bowing (FIGURE 1A). Regular interval imaging performed at routine well-child examinations at 19 months, 3 years, and 5 years of age showed progression of the femoral length discrepancy from 2 cm to nearly 5 cm, remaining proportionally constant, as well as increasing genu valgum of the right leg up to 12 degrees (FIGURE 1B-D).

DISCUSSION

Congenital femoral bowing, which can present as a leg-length discrepancy in infants, is a relatively rare finding with an incidence of 1 per 52,000 births.⁴ Our patient presented with an isolated limb deformity, but congenital femoral bowing is recognized as a clinical feature of several skeletal dysplasias (TABLE 2).⁵

What’s recommended

The American Academy of Pediatrics recommends routine age-appropriate physical examination without specifying leg-length assessment.⁶ There is insufficient evidence, according to the US Preventive Services Task Force and the American Academy of Pediatrics, regarding the value of routine infant hip and leg-length assessment for developmental dysplasia of the hip and other musculoskeletal abnormalities; however, both agree that abnormal findings require follow-up and management.^6-8

Congenital femoral bowing requires plain film diagnosis

Following physical examination, diagnosis of congenital femoral bowing should be confirmed by plain films. Plain radiography remains the main imaging modality for proximal focal femoral deficiency and fibular hemimelia, and appropriate identification of the osseous abnormalities seen on radiographs allows for accurate classification of congenital femoral bowing, prognosis, and surgical planning. (Minor malformations associated with congenital leg-length discrepancies are not typically identified as being part of a larger syndromic diagnosis.⁴) The patient should subsequently be referred to an orthopedist for monitoring and to establish a long-term management plan.

Continue to: Early diagnosis can improve treatment outcome

Early diagnosis can improve treatment outcome

Both early diagnosis of congenital femoral bowing and prediction of leg-length discrepancy at skeletal maturity can influence potential treatment options, which range from conservative management (eg, watchful waiting, physical therapy, shoe lifts, orthotics, bracing) to surgical intervention. Several models have been used to predict skeletal growth, including the Moseley straight line graph, Green and Anderson growth curve, Amstutz method, and Paley’s multiplier method.^4,9-14

Congenital femoral bowing may present clinically as a leg-length discrepancy with no indication of trauma or disease.

Intervention for leg-length discrepancy generally is dictated by the magnitude of the inequality and the presence of functional deficits and/or pain.² If the degree of femur angulation begins to affect structural development, surgical intervention should be considered to align development and/or correct the discrepancy. Physical therapy, shoe lifts, orthotics, and bracing are treatment options for managing smaller discrepancies.^2,15

Our patient. The physician (CP) reviewed treatment options with the family that included watchful waiting, use of a shoe lift and/or orthotics, and bracing. The family chose watchful waiting due to the structural integrity of the patient’s other major joints and her relatively preserved function. The patient demonstrated mild gross motor delay at routine well-child visits at 9, 12, and 15 months, but was walking by 19 months. Her development was otherwise normal as documented via regular developmental screenings at routine well-child examinations. The patient participated in home physical therapy to maintain strength, flexibility, and functional mobility, and she was able to ambulate by walking on her right toes.

Surgery. Ultimately the patient underwent medial distal femoral hemiepiphysiodesis of the right lower extremity at 6 years of age due to increasing leg-length discrepancy and lateralization of the patella from the valgus deformity. The patient’s mother reported that she did well postoperatively, with increased range of motion, improved physical capabilities, and reduced discomfort in the right leg. She continued to participate in physical therapy and had routine follow-up with her physical therapist, her FP, and orthopedist.

A second surgery. At approximately 8 years and 9 months of age, the orthopedist noted that the patient’s leg-length discrepancy had increased, and she had right extensor mechanism malalignment and severe patellar subluxation. The patient subsequently underwent surgery to remove the existing hardware, including right extensor mechanism realignment via a Roux-Goldthwait procedure (with reconstruction of the medial patellofemoral ligament and anterior cruciate ligament), as well as left distal femoral epiphysiodesis. She did very well postoperatively and continues to participate in physical therapy approximately once weekly. She has had an improvement in her gait and stability using shoe lifts.

Continue to: THE TAKEAWAY

 

 

THE TAKEAWAY

A routine well-child examination can be an opportunity to identify congenital musculoskeletal problems. Congenital femoral bowing is a relatively rare finding⁴ that may present as a leg-length discrepancy. With proper evaluation, including visual inspection, palpation, range-of-motion testing, and special tests as needed (eg, Galeazzi test, Ortolani and Barlow maneuvers), early intervention is possible if a leg-length discrepancy is noted. Close monitoring of gait abnormalities at routine well-child visits is essential.

Physical therapy, shoe lift therapy, and surgical approaches are treatment options for leg-length discrepancy,² and early intervention can improve treatment outcomes.¹⁴ Understanding how to manage congenital femoral bowing over time is important in providing options and counselling patients and their families.¹⁵

Treatment of leg-length discrepancy in pediatric patients requires long-term management with a team approach that includes patients and their families. The goal of intervention is to reduce physical and emotional trauma, while addressing complications and maintaining function of the affected limb, as well as the whole body.¹⁵

CORRESPONDENCE
Beth P. Davis, DPT, MBA, FNAP, Emory University School of Medicine, Department of Rehabilitation Medicine, Division of Physical Therapy, 1462 Clifton Road NE, Suite 312, Atlanta, GA 30342; bethpdavis@emory.edu.

More than 60% of newborns appear clinically jaundiced in the first few weeks of life,¹ most often due to physiologic jaundice. Mild hyperbilirubinemia peaks at Days 3 to 5 and returns to normal in the following weeks.¹ However, approximately 10% of term and 25% of late preterm infants will undergo phototherapy for hyperbilirubinemia in an effort to prevent acute bilirubin encephalopathy (ABE) and kernicterus.²

Heightened vigilance to prevent these rare but devastating outcomes has made hyperbilirubinemia the most common cause of hospital readmission in infants in the United States³ and one with significant health care costs. This article summarizes the evidence and recommendations for the screening, evaluation, and management of hyperbilirubinemia in term infants.

But first, we begin with a quick look at the causes of hyperbilirubinemia.

Causes of conjugated vs unconjugated hyperbilirubinemia

Bilirubin is generated when red blood cells break down and release heme, which is metabolized into biliverdin and then to bilirubin. Unconjugated bilirubin binds to albumin in the blood and is transported to hepatocytes where conjugation occurs, allowing it to be excreted through the gastrointestinal tract. In neonates, most of the conjugated bilirubin that reaches the gut is then unconjugated, resulting in its recirculation. Additionally, neonates have an increased volume of red blood cells and a slow conjugating system. These factors all contribute to excess unconjugated bilirubin, which manifests as physiologic, nonpathologic jaundice.⁴TABLE 1^4-6 lists causes of unconjugated hyperbilirubinemia.

Elevated conjugated hyperbilirubinemia (conjugated bilirubin level ≥20% of total serum bilirubin [TSB]) is always pathologic and occurs due to intrahepatic or extrahepatic obstruction. TABLE 2⁷ lists causes of conjugated hyperbilirubinemia. Infants found to have conjugated hyperbilirubinemia should undergo an additional work-up to determine the cause and identify potential complications of this disease.⁸

Given that the differential for conjugated hyperbilirubinemia is so broad and that it is often associated with severe disease requiring complicated and invasive treatments, infants with conjugated hyperbilirubinemia should be referred to a pediatric tertiary care facility with pediatric gastroenterologists, infectious disease specialists, and surgeons.⁷

What puts newborns at risk?

Major and minor risk factors for the development of severe hyperbilirubinemia in well newborns ≥35 weeks’ gestation are listed in TABLE 3.⁹ Those that carry the highest risk include gestational age <38 weeks, having a sibling who required phototherapy, visible jaundice by the time of discharge, and exclusive breastfeeding.⁹ Several more recent cohort studies, however, suggest that breastfeeding may not be a significant risk factor.¹⁰ The more risk factors present, the higher the risk. Infants who are formula fed, age ≥41 gestational weeks, or have no major or minor risk factors have a very low likelihood of developing severe hyperbilirubinemia.⁹

Continue to: The Bhutani curve...

The Bhutani curve¹¹ is a widely used, validated nomogram based on pre-discharge hour-specific serum bilirubin measurements. (Go to http://pediatrics.aappublications.org/content/114/1/297 and see Figure 2.) It is the most reliable way to assess the risk for subsequent development of significant hyperbilirubinemia requiring phototherapy.⁹ As such, it is the basis for several online calculators and apps such as BiliTool (bilitool.org).

An alternative nomogram developed by Varvarigou et al¹² is available for predicting significant hyperbilirubinemia based on transcutaneous bilirubin assessment. (Go to https://pdfs.semanticscholar.org/a9a6/5a988dba7a3442bcebc149ad5aea5e3c35d5.pdf and see Figure 3.) The American Academy of Pediatrics (AAP) supports the use of either bilirubin assessment for the screening and diagnosis of hyperbilirubinemia in infants ≥35 weeks’ gestation.⁹

Neurotoxicity risk factors. It is important to differentiate the major and minor risk factors for severe hyperbilirubinemia from neurotoxicity risk factors, also listed in TABLE 3.⁹ Neurotoxicity risk factors are indicative of conditions that may affect albumin binding of bilirubin and are thought to lower the threshold at which bilirubin may cross the blood-brain barrier and render the brain more susceptible to damage from bilirubin. These neurotoxicity risk factors should be applied to the AAP phototherapy nomogram (see Figure 3 at pediatrics.aappublications.org/content/114/1/297) to determine the threshold for initiation of phototherapy in infants with hyperbilirubinemia.⁹

Hyperbilirubinemia is the most common cause of hospital readmission of infants in the United States.

Few investigators have attempted to define risk factors for the development of poor neurologic outcomes associated with hyperbilirubinemia. Evidence to date has not allowed the determination of a specific bilirubin level at which subsequent development of kernicterus occurs.⁹ The limited data available suggest a poor correlation between TSB level and bilirubin-induced neurologic dysfunction.¹³

(For more on kernicterus, as well as ABE and bilirubin-induced neurologic dysfunction [BIND], see “Why do we worry about hyperbilirubinemia?”^9,14-16)

Continue to: Diagnosis relies on TSB and/or TcB

Diagnosis relies on TSB and/or TcB

TSB measurement is the traditional and most widely used method for screening and diagnosing neonatal hyperbilirubinemia, but the blood draw is invasive and carries a risk (albeit low) of infection and anemia.¹⁷ Transcutaneous bilirubin (TcB) assessment is a noninvasive alternative that generally correlates well with TSB values ≤15 mg/dL,^17-20 even in Hispanic, African, and multiethnic populations.^18,21,22

Diagnosis of hyperbilirubinemia is made with TSB or TcB measured at >95th percentile for age in hours. TcB levels measured at >15 mg/dL should be confirmed with TSB measurement. Visual assessment of jaundice should not be used for diagnosis, as it may lead to errors.^9-23

The total cost of testing is lower with TcB ($4-$15 per patient¹⁷) than with TSB when the cost of supplies and personnel are considered.²⁴ Although more recent evidence suggests that TcB is an acceptable way to measure bilirubin in premature infants, no professional society currently recommends the use of TcB for the diagnosis of hyperbilirubinemia in infants²⁵ <35 weeks’ gestation.

Screening recommendations lack consensus

There is a lack of consensus among professional societies on appropriate screening for neonatal hyperbilirubinemia, likely due to limited available data, necessitating expert-driven recommendations.

The AAP recommends universal screening of infants ≥35 weeks’ gestation prior to discharge with measurement of TSB/TcB and/or clinical assessment.⁹ The Canadian Pediatric Society recommends universal screening with TSB/TcB measurement in all infants in the first 72 hours of life.²⁶

Continue to: The US Preventive Services Task Force...

The US Preventative Services Task Force, however, found insufficient evidence to recommend universal screening for infants ≥35 weeks’ gestation.²⁷ The main rationale for their “I” recommendation was that although screening can identify infants at risk of developing severe hyperbilirubinemia, there is no clear evidence that identifying and treating elevated bilirubin levels results in the prevention of kernicterus.

The United Kingdom’s National Institute for Health and Care Excellence (NICE) guidelines do not support universal screening either.²⁸ NICE recommends risk factor assessment and visual inspection for jaundice in all newborns and also additional physical examination for newborns with risk factors. NICE recommends against routine monitoring of bilirubin levels in infants who do not appear jaundiced.

Several recent cohort studies suggest that breastfeeding may not be a significant risk factor for hyperbilirubinemia.

All infants who appear jaundiced should be evaluated with either risk factor assessment or bilirubin measurement (TSB or TcB). Infants born to mothers who are Rh-negative or have type O blood should have cord blood tested for blood type, Rh status, and other antibodies with a direct Coombs test, as ABO and Rh incompatibility are major risk factors for development of hyperbilirubinemia because of hemolysis.^8,9

A question of cost-efficacy? Data from a multicenter prospective clinical trial suggest a number needed to screen of 128,600 to prevent 1 case of kernicterus,²⁹ making cost another important factor in the discussion about screening for neonatal hyperbilirubinemia. Universal screening is associated not only with the cost of TSB and TcB measurements, but also with the cost of phototherapy, rates of which are increased with universal screening.^24,29,30 The cost of caring for 1 patient with kernicterus over a lifetime is estimated at $900,000, while the estimated cost to prevent 1 case of kernicterus with universal TSB/TcB screening is between $5.7 and $9.2 million.³¹

In Canada, universal screening was found to decrease emergency department visits for jaundice, but did not affect rates of readmission for hyperbilirubinemia, length of hospital stay, or rates of phototherapy after discharge.³⁰

Continue to: Phototherapy: What kind of light, when to initiate

Phototherapy: What kind of light, when to initiate

The initial management of hyperbilirubinemia is phototherapy. Light directed at the skin converts bilirubin to lumirubin—a compound that unlike bilirubin does not require conjugation in the liver and can be directly excreted in the urine or bile.⁸

No professional society currently recommends the use of TcB for the diagnosis of hyperbilirubinemia in infants <35 weeks’ gestation.

Light in the blue-green spectrum (460-490 nm) is most effective. Generally, phototherapy is more effective the closer the light is to the infant and the greater the surface area of skin the infant has exposed. There are many different types of lights used to provide phototherapy including fluorescent, halogen, light emitting diode (LED), and fiber optic lights, which are commonly used in home biliblankets.⁸ Fluorescent and halogen lights are the conventional methods, but newer LED systems are equally effective in terms of rate of decline of serum bilirubin levels, duration of phototherapy required, and need for exchange transfusion. Fiber optic lights work as well as other lights in preterm infants but are less effective in term infants. Using 2 fiber optic lights in term infants can increase efficacy to the level of a single conventional or LED source.³²

Phototherapy thresholds. The AAP phototherapy curve (see Figure 3 at http://pediatrics.aappublications.org/content/114/1/297) is commonly used to determine phototherapy thresholds for infants with hyperbilirubinemia. This nomogram applies TSB level and age in hours to a “low,” “medium,” or “high” risk curve that is determined by the presence of neurotoxicity risk factors and gestational age. Infants on the “medium” and “high” risk curves have lower thresholds for initiation of phototherapy.⁹ The majority of infants born at gestational age ≥38 weeks being cared for in a newborn nursery will be assigned to a low risk curve on the AAP phototherapy nomogram, as many of the neurotoxicity risk factors that elevate risk would also be reasons for infants to be in an intensive care unit.

Online calculators and apps based on the AAP phototherapy nomogram, such as BiliTool (bilitool.org), offer recommendations for phototherapy thresholds and may suggest a time interval at which to repeat bilirubin testing if phototherapy is not indicated.

The additional work-up for infants requiring phototherapy often includes neonatal blood type, direct Coombs test, complete blood count and smear, and conjugated bilirubin level.⁹ Besser et al,³³ however, found that 88% of infants requiring phototherapy had normal laboratory results. They also found that those infants with lab abnormalities often started phototherapy before 48 hours of age and did not have an appropriate decrease in bilirubin after initiation of phototherapy.

Continue to: Timing

Timing. Based on this data, it is reasonable to start phototherapy in term infants who develop jaundice at >48 to 72 hours of age without doing additional testing.

Bilirubin levels are expected to drop about 0.5 mg/dL per hour in the first 4 to 8 hours after starting phototherapy, but if the bilirubin measurement is not decreasing as expected or is increasing, additional work-up, with reticulocyte count, G6PD (glucose-6-phosphate dehydrogenase) concentration, end-tidal carbon dioxide determination (ETCO), and a bilirubin/albumin (B/A) ratio is warranted.⁸ Since unbound bilirubin can cross the blood-brain barrier, increased B/A ratio could theoretically be a predictor of bilirubin-induced neurologic dysfunction risk, but Iskander et al³⁴ found that it was not superior to TSB levels in predicting neurotoxicity. ETCO may help identify children with ongoing hemolysis.⁸

The ideal time to stop phototherapy is not clear. Expert recommendations for phototherapy discontinuation thresholds range from 4-5 mg/dL to 13-14 mg/dL,⁸ while other clinicians stop phototherapy when bilirubin falls 1 to 2 mg/dL below the phototherapy initiation threshold. Phototherapy should be continued for any infant with signs of acute bilirubin encephalopathy, even if the bilirubin level is decreasing.⁹ Rebound hyperbilirubinemia is rare, and checking rebound bilirubin levels is not recommended.⁸

Safety. Phototherapy is generally considered safe, but both short- and long-term adverse effects are possible. Immediate adverse effects include intestinal hypermobility/diarrhea and temperature instability. Long-term issues include increased risks of the development of childhood asthma (odds ratio=1.4) and type 1 diabetes (odds ratio=3.79).³⁵ Phototherapy can also be distressing for parents, as it requires frequent blood draws, physical separation, and possible disruption of breastfeeding.³⁶ One study found a number needed to harm of 4 for cessation of breastfeeding at 1 month in jaundiced infants.³⁷

Maintain breastfeeding. The AAP recommends breastfeeding be continued and promoted in infants who are jaundiced and receiving phototherapy.⁹ Maternal interaction with health care professionals who are encouraging of this practice was the best predictor of ongoing breastfeeding in a qualitative study of jaundiced infants and their families.³⁸ Interrupting phototherapy for up to 30 minutes to allow for breastfeeding without eye covers has not been shown to decrease the efficacy of phototherapy.³⁸

Continue to: Available evidence does not provide a clear answer...

Available evidence does not provide a clear answer regarding whether formula supplementation should be initiated in breastfed infants with hyperbilirubinemia. Cow’s milk formula supplementation decreases intestinal reabsorption of bilirubin, lowering serum bilirubin levels, but may interfere with successful breastfeeding.³⁹ The Academy of Breastfeeding Medicine recommends an individual discussion about formula supplementation in place of, or prior to, phototherapy if an infant’s bilirubin is approaching (within 2-3 mg/dL) or above the threshold for phototherapy.³⁹ Routine supplementation with intravenous fluids or other non–milk-based supplementation is not recommended for infants receiving phototherapy.⁹

Adjuvant therapies and exchange transfusion

Clofibrate, metalloporphyrins, and ursodiol have been studied in the management of unconjugated hyperbilirubinemia as augmentation to phototherapy. Honar et al⁴⁰ found that ursodiol added at the time of phototherapy initiation demonstrated a significant reduction in peak bilirubin levels and duration of phototherapy in term infants with unconjugated hyperbilirubinemia without any adverse effects. Cochrane reviews of clofibrat⁵ and metalloporphyrins⁴¹ found that when added to phototherapy, these medications significantly decreased serum bilirubin levels and duration of phototherapy. However, there was insufficient evidence to recommend their use due to inadequate data on safety and long-term outcomes.

Exchange transfusion. Infants with bilirubin levels >25 mg/dL, those who are not responding to phototherapy, and those with evidence of acute bilirubin encephalopathy should be treated with exchange transfusion, with initiation based on an infant’s age in hours and neurotoxicity risk factors.⁹ Exchange transfusion involves taking small aliquots of blood from the infant and replacing them with donor red cells until the infant’s blood volume has been replaced twice to remove bilirubin and antibodies that may be causing hemolysis. It should be carried out in a neonatal intensive care unit due to significant risks.

About 88% of infants requiring phototherapy have normal laboratory study results.

Approximately 12% of infants have a complication from exchange transfusion including infection, electrolyte imbalances, thrombosis, thrombocytopenia, and necrotizing enterocolitis.⁸ The mortality rate in neonates without hemolysis who undergo exchange transfusion is 3 to 4 per 1000 treated.⁴²

Post-discharge follow-up

Infants discharged before 72 hours of life should be seen within 2 days of discharge. Those infants with significant risk factors for development of severe hyperbilirubinemia should be seen within 1 day. Arrangements for follow-up should be made prior to discharge. Some infants discharged before 48 hours of life may require 2 follow-up visits. If follow-up cannot be ensured for an infant with risk factors for the development of severe hyperbilirubinemia, delay of discharge may be appropriate.⁹

CORRESPONDENCE
Katharine C. DeGeorge, MD, MS, Department of Family Medicine, University of Virginia, PO Box 800729, Charlottesville, VA, 22908-0729; kd6fp@virginia.edu.

More than 60% of newborns appear clinically jaundiced in the first few weeks of life,¹ most often due to physiologic jaundice. Mild hyperbilirubinemia peaks at Days 3 to 5 and returns to normal in the following weeks.¹ However, approximately 10% of term and 25% of late preterm infants will undergo phototherapy for hyperbilirubinemia in an effort to prevent acute bilirubin encephalopathy (ABE) and kernicterus.²

Heightened vigilance to prevent these rare but devastating outcomes has made hyperbilirubinemia the most common cause of hospital readmission in infants in the United States³ and one with significant health care costs. This article summarizes the evidence and recommendations for the screening, evaluation, and management of hyperbilirubinemia in term infants.

But first, we begin with a quick look at the causes of hyperbilirubinemia.

Causes of conjugated vs unconjugated hyperbilirubinemia

Bilirubin is generated when red blood cells break down and release heme, which is metabolized into biliverdin and then to bilirubin. Unconjugated bilirubin binds to albumin in the blood and is transported to hepatocytes where conjugation occurs, allowing it to be excreted through the gastrointestinal tract. In neonates, most of the conjugated bilirubin that reaches the gut is then unconjugated, resulting in its recirculation. Additionally, neonates have an increased volume of red blood cells and a slow conjugating system. These factors all contribute to excess unconjugated bilirubin, which manifests as physiologic, nonpathologic jaundice.⁴TABLE 1^4-6 lists causes of unconjugated hyperbilirubinemia.

Elevated conjugated hyperbilirubinemia (conjugated bilirubin level ≥20% of total serum bilirubin [TSB]) is always pathologic and occurs due to intrahepatic or extrahepatic obstruction. TABLE 2⁷ lists causes of conjugated hyperbilirubinemia. Infants found to have conjugated hyperbilirubinemia should undergo an additional work-up to determine the cause and identify potential complications of this disease.⁸

Given that the differential for conjugated hyperbilirubinemia is so broad and that it is often associated with severe disease requiring complicated and invasive treatments, infants with conjugated hyperbilirubinemia should be referred to a pediatric tertiary care facility with pediatric gastroenterologists, infectious disease specialists, and surgeons.⁷

What puts newborns at risk?

Major and minor risk factors for the development of severe hyperbilirubinemia in well newborns ≥35 weeks’ gestation are listed in TABLE 3.⁹ Those that carry the highest risk include gestational age <38 weeks, having a sibling who required phototherapy, visible jaundice by the time of discharge, and exclusive breastfeeding.⁹ Several more recent cohort studies, however, suggest that breastfeeding may not be a significant risk factor.¹⁰ The more risk factors present, the higher the risk. Infants who are formula fed, age ≥41 gestational weeks, or have no major or minor risk factors have a very low likelihood of developing severe hyperbilirubinemia.⁹

Continue to: The Bhutani curve...

The Bhutani curve¹¹ is a widely used, validated nomogram based on pre-discharge hour-specific serum bilirubin measurements. (Go to http://pediatrics.aappublications.org/content/114/1/297 and see Figure 2.) It is the most reliable way to assess the risk for subsequent development of significant hyperbilirubinemia requiring phototherapy.⁹ As such, it is the basis for several online calculators and apps such as BiliTool (bilitool.org).

An alternative nomogram developed by Varvarigou et al¹² is available for predicting significant hyperbilirubinemia based on transcutaneous bilirubin assessment. (Go to https://pdfs.semanticscholar.org/a9a6/5a988dba7a3442bcebc149ad5aea5e3c35d5.pdf and see Figure 3.) The American Academy of Pediatrics (AAP) supports the use of either bilirubin assessment for the screening and diagnosis of hyperbilirubinemia in infants ≥35 weeks’ gestation.⁹

Neurotoxicity risk factors. It is important to differentiate the major and minor risk factors for severe hyperbilirubinemia from neurotoxicity risk factors, also listed in TABLE 3.⁹ Neurotoxicity risk factors are indicative of conditions that may affect albumin binding of bilirubin and are thought to lower the threshold at which bilirubin may cross the blood-brain barrier and render the brain more susceptible to damage from bilirubin. These neurotoxicity risk factors should be applied to the AAP phototherapy nomogram (see Figure 3 at pediatrics.aappublications.org/content/114/1/297) to determine the threshold for initiation of phototherapy in infants with hyperbilirubinemia.⁹

Hyperbilirubinemia is the most common cause of hospital readmission of infants in the United States.

Few investigators have attempted to define risk factors for the development of poor neurologic outcomes associated with hyperbilirubinemia. Evidence to date has not allowed the determination of a specific bilirubin level at which subsequent development of kernicterus occurs.⁹ The limited data available suggest a poor correlation between TSB level and bilirubin-induced neurologic dysfunction.¹³

(For more on kernicterus, as well as ABE and bilirubin-induced neurologic dysfunction [BIND], see “Why do we worry about hyperbilirubinemia?”^9,14-16)

Continue to: Diagnosis relies on TSB and/or TcB

Diagnosis relies on TSB and/or TcB

TSB measurement is the traditional and most widely used method for screening and diagnosing neonatal hyperbilirubinemia, but the blood draw is invasive and carries a risk (albeit low) of infection and anemia.¹⁷ Transcutaneous bilirubin (TcB) assessment is a noninvasive alternative that generally correlates well with TSB values ≤15 mg/dL,^17-20 even in Hispanic, African, and multiethnic populations.^18,21,22

Diagnosis of hyperbilirubinemia is made with TSB or TcB measured at >95th percentile for age in hours. TcB levels measured at >15 mg/dL should be confirmed with TSB measurement. Visual assessment of jaundice should not be used for diagnosis, as it may lead to errors.^9-23

The total cost of testing is lower with TcB ($4-$15 per patient¹⁷) than with TSB when the cost of supplies and personnel are considered.²⁴ Although more recent evidence suggests that TcB is an acceptable way to measure bilirubin in premature infants, no professional society currently recommends the use of TcB for the diagnosis of hyperbilirubinemia in infants²⁵ <35 weeks’ gestation.

Screening recommendations lack consensus

There is a lack of consensus among professional societies on appropriate screening for neonatal hyperbilirubinemia, likely due to limited available data, necessitating expert-driven recommendations.

The AAP recommends universal screening of infants ≥35 weeks’ gestation prior to discharge with measurement of TSB/TcB and/or clinical assessment.⁹ The Canadian Pediatric Society recommends universal screening with TSB/TcB measurement in all infants in the first 72 hours of life.²⁶

Continue to: The US Preventive Services Task Force...

The US Preventative Services Task Force, however, found insufficient evidence to recommend universal screening for infants ≥35 weeks’ gestation.²⁷ The main rationale for their “I” recommendation was that although screening can identify infants at risk of developing severe hyperbilirubinemia, there is no clear evidence that identifying and treating elevated bilirubin levels results in the prevention of kernicterus.

The United Kingdom’s National Institute for Health and Care Excellence (NICE) guidelines do not support universal screening either.²⁸ NICE recommends risk factor assessment and visual inspection for jaundice in all newborns and also additional physical examination for newborns with risk factors. NICE recommends against routine monitoring of bilirubin levels in infants who do not appear jaundiced.

Several recent cohort studies suggest that breastfeeding may not be a significant risk factor for hyperbilirubinemia.

All infants who appear jaundiced should be evaluated with either risk factor assessment or bilirubin measurement (TSB or TcB). Infants born to mothers who are Rh-negative or have type O blood should have cord blood tested for blood type, Rh status, and other antibodies with a direct Coombs test, as ABO and Rh incompatibility are major risk factors for development of hyperbilirubinemia because of hemolysis.^8,9

A question of cost-efficacy? Data from a multicenter prospective clinical trial suggest a number needed to screen of 128,600 to prevent 1 case of kernicterus,²⁹ making cost another important factor in the discussion about screening for neonatal hyperbilirubinemia. Universal screening is associated not only with the cost of TSB and TcB measurements, but also with the cost of phototherapy, rates of which are increased with universal screening.^24,29,30 The cost of caring for 1 patient with kernicterus over a lifetime is estimated at $900,000, while the estimated cost to prevent 1 case of kernicterus with universal TSB/TcB screening is between $5.7 and $9.2 million.³¹

In Canada, universal screening was found to decrease emergency department visits for jaundice, but did not affect rates of readmission for hyperbilirubinemia, length of hospital stay, or rates of phototherapy after discharge.³⁰

Continue to: Phototherapy: What kind of light, when to initiate

Phototherapy: What kind of light, when to initiate

The initial management of hyperbilirubinemia is phototherapy. Light directed at the skin converts bilirubin to lumirubin—a compound that unlike bilirubin does not require conjugation in the liver and can be directly excreted in the urine or bile.⁸

No professional society currently recommends the use of TcB for the diagnosis of hyperbilirubinemia in infants <35 weeks’ gestation.

Light in the blue-green spectrum (460-490 nm) is most effective. Generally, phototherapy is more effective the closer the light is to the infant and the greater the surface area of skin the infant has exposed. There are many different types of lights used to provide phototherapy including fluorescent, halogen, light emitting diode (LED), and fiber optic lights, which are commonly used in home biliblankets.⁸ Fluorescent and halogen lights are the conventional methods, but newer LED systems are equally effective in terms of rate of decline of serum bilirubin levels, duration of phototherapy required, and need for exchange transfusion. Fiber optic lights work as well as other lights in preterm infants but are less effective in term infants. Using 2 fiber optic lights in term infants can increase efficacy to the level of a single conventional or LED source.³²

Phototherapy thresholds. The AAP phototherapy curve (see Figure 3 at http://pediatrics.aappublications.org/content/114/1/297) is commonly used to determine phototherapy thresholds for infants with hyperbilirubinemia. This nomogram applies TSB level and age in hours to a “low,” “medium,” or “high” risk curve that is determined by the presence of neurotoxicity risk factors and gestational age. Infants on the “medium” and “high” risk curves have lower thresholds for initiation of phototherapy.⁹ The majority of infants born at gestational age ≥38 weeks being cared for in a newborn nursery will be assigned to a low risk curve on the AAP phototherapy nomogram, as many of the neurotoxicity risk factors that elevate risk would also be reasons for infants to be in an intensive care unit.

Online calculators and apps based on the AAP phototherapy nomogram, such as BiliTool (bilitool.org), offer recommendations for phototherapy thresholds and may suggest a time interval at which to repeat bilirubin testing if phototherapy is not indicated.

The additional work-up for infants requiring phototherapy often includes neonatal blood type, direct Coombs test, complete blood count and smear, and conjugated bilirubin level.⁹ Besser et al,³³ however, found that 88% of infants requiring phototherapy had normal laboratory results. They also found that those infants with lab abnormalities often started phototherapy before 48 hours of age and did not have an appropriate decrease in bilirubin after initiation of phototherapy.

Continue to: Timing

Timing. Based on this data, it is reasonable to start phototherapy in term infants who develop jaundice at >48 to 72 hours of age without doing additional testing.

Bilirubin levels are expected to drop about 0.5 mg/dL per hour in the first 4 to 8 hours after starting phototherapy, but if the bilirubin measurement is not decreasing as expected or is increasing, additional work-up, with reticulocyte count, G6PD (glucose-6-phosphate dehydrogenase) concentration, end-tidal carbon dioxide determination (ETCO), and a bilirubin/albumin (B/A) ratio is warranted.⁸ Since unbound bilirubin can cross the blood-brain barrier, increased B/A ratio could theoretically be a predictor of bilirubin-induced neurologic dysfunction risk, but Iskander et al³⁴ found that it was not superior to TSB levels in predicting neurotoxicity. ETCO may help identify children with ongoing hemolysis.⁸

The ideal time to stop phototherapy is not clear. Expert recommendations for phototherapy discontinuation thresholds range from 4-5 mg/dL to 13-14 mg/dL,⁸ while other clinicians stop phototherapy when bilirubin falls 1 to 2 mg/dL below the phototherapy initiation threshold. Phototherapy should be continued for any infant with signs of acute bilirubin encephalopathy, even if the bilirubin level is decreasing.⁹ Rebound hyperbilirubinemia is rare, and checking rebound bilirubin levels is not recommended.⁸

Safety. Phototherapy is generally considered safe, but both short- and long-term adverse effects are possible. Immediate adverse effects include intestinal hypermobility/diarrhea and temperature instability. Long-term issues include increased risks of the development of childhood asthma (odds ratio=1.4) and type 1 diabetes (odds ratio=3.79).³⁵ Phototherapy can also be distressing for parents, as it requires frequent blood draws, physical separation, and possible disruption of breastfeeding.³⁶ One study found a number needed to harm of 4 for cessation of breastfeeding at 1 month in jaundiced infants.³⁷

Maintain breastfeeding. The AAP recommends breastfeeding be continued and promoted in infants who are jaundiced and receiving phototherapy.⁹ Maternal interaction with health care professionals who are encouraging of this practice was the best predictor of ongoing breastfeeding in a qualitative study of jaundiced infants and their families.³⁸ Interrupting phototherapy for up to 30 minutes to allow for breastfeeding without eye covers has not been shown to decrease the efficacy of phototherapy.³⁸

Continue to: Available evidence does not provide a clear answer...

Available evidence does not provide a clear answer regarding whether formula supplementation should be initiated in breastfed infants with hyperbilirubinemia. Cow’s milk formula supplementation decreases intestinal reabsorption of bilirubin, lowering serum bilirubin levels, but may interfere with successful breastfeeding.³⁹ The Academy of Breastfeeding Medicine recommends an individual discussion about formula supplementation in place of, or prior to, phototherapy if an infant’s bilirubin is approaching (within 2-3 mg/dL) or above the threshold for phototherapy.³⁹ Routine supplementation with intravenous fluids or other non–milk-based supplementation is not recommended for infants receiving phototherapy.⁹

Adjuvant therapies and exchange transfusion

Clofibrate, metalloporphyrins, and ursodiol have been studied in the management of unconjugated hyperbilirubinemia as augmentation to phototherapy. Honar et al⁴⁰ found that ursodiol added at the time of phototherapy initiation demonstrated a significant reduction in peak bilirubin levels and duration of phototherapy in term infants with unconjugated hyperbilirubinemia without any adverse effects. Cochrane reviews of clofibrat⁵ and metalloporphyrins⁴¹ found that when added to phototherapy, these medications significantly decreased serum bilirubin levels and duration of phototherapy. However, there was insufficient evidence to recommend their use due to inadequate data on safety and long-term outcomes.

Exchange transfusion. Infants with bilirubin levels >25 mg/dL, those who are not responding to phototherapy, and those with evidence of acute bilirubin encephalopathy should be treated with exchange transfusion, with initiation based on an infant’s age in hours and neurotoxicity risk factors.⁹ Exchange transfusion involves taking small aliquots of blood from the infant and replacing them with donor red cells until the infant’s blood volume has been replaced twice to remove bilirubin and antibodies that may be causing hemolysis. It should be carried out in a neonatal intensive care unit due to significant risks.

About 88% of infants requiring phototherapy have normal laboratory study results.

Approximately 12% of infants have a complication from exchange transfusion including infection, electrolyte imbalances, thrombosis, thrombocytopenia, and necrotizing enterocolitis.⁸ The mortality rate in neonates without hemolysis who undergo exchange transfusion is 3 to 4 per 1000 treated.⁴²

Post-discharge follow-up

Infants discharged before 72 hours of life should be seen within 2 days of discharge. Those infants with significant risk factors for development of severe hyperbilirubinemia should be seen within 1 day. Arrangements for follow-up should be made prior to discharge. Some infants discharged before 48 hours of life may require 2 follow-up visits. If follow-up cannot be ensured for an infant with risk factors for the development of severe hyperbilirubinemia, delay of discharge may be appropriate.⁹

CORRESPONDENCE
Katharine C. DeGeorge, MD, MS, Department of Family Medicine, University of Virginia, PO Box 800729, Charlottesville, VA, 22908-0729; kd6fp@virginia.edu.

More than 60% of newborns appear clinically jaundiced in the first few weeks of life,¹ most often due to physiologic jaundice. Mild hyperbilirubinemia peaks at Days 3 to 5 and returns to normal in the following weeks.¹ However, approximately 10% of term and 25% of late preterm infants will undergo phototherapy for hyperbilirubinemia in an effort to prevent acute bilirubin encephalopathy (ABE) and kernicterus.²

Heightened vigilance to prevent these rare but devastating outcomes has made hyperbilirubinemia the most common cause of hospital readmission in infants in the United States³ and one with significant health care costs. This article summarizes the evidence and recommendations for the screening, evaluation, and management of hyperbilirubinemia in term infants.

But first, we begin with a quick look at the causes of hyperbilirubinemia.

Causes of conjugated vs unconjugated hyperbilirubinemia

Bilirubin is generated when red blood cells break down and release heme, which is metabolized into biliverdin and then to bilirubin. Unconjugated bilirubin binds to albumin in the blood and is transported to hepatocytes where conjugation occurs, allowing it to be excreted through the gastrointestinal tract. In neonates, most of the conjugated bilirubin that reaches the gut is then unconjugated, resulting in its recirculation. Additionally, neonates have an increased volume of red blood cells and a slow conjugating system. These factors all contribute to excess unconjugated bilirubin, which manifests as physiologic, nonpathologic jaundice.⁴TABLE 1^4-6 lists causes of unconjugated hyperbilirubinemia.

Elevated conjugated hyperbilirubinemia (conjugated bilirubin level ≥20% of total serum bilirubin [TSB]) is always pathologic and occurs due to intrahepatic or extrahepatic obstruction. TABLE 2⁷ lists causes of conjugated hyperbilirubinemia. Infants found to have conjugated hyperbilirubinemia should undergo an additional work-up to determine the cause and identify potential complications of this disease.⁸

Given that the differential for conjugated hyperbilirubinemia is so broad and that it is often associated with severe disease requiring complicated and invasive treatments, infants with conjugated hyperbilirubinemia should be referred to a pediatric tertiary care facility with pediatric gastroenterologists, infectious disease specialists, and surgeons.⁷

What puts newborns at risk?

Major and minor risk factors for the development of severe hyperbilirubinemia in well newborns ≥35 weeks’ gestation are listed in TABLE 3.⁹ Those that carry the highest risk include gestational age <38 weeks, having a sibling who required phototherapy, visible jaundice by the time of discharge, and exclusive breastfeeding.⁹ Several more recent cohort studies, however, suggest that breastfeeding may not be a significant risk factor.¹⁰ The more risk factors present, the higher the risk. Infants who are formula fed, age ≥41 gestational weeks, or have no major or minor risk factors have a very low likelihood of developing severe hyperbilirubinemia.⁹

Continue to: The Bhutani curve...

The Bhutani curve¹¹ is a widely used, validated nomogram based on pre-discharge hour-specific serum bilirubin measurements. (Go to http://pediatrics.aappublications.org/content/114/1/297 and see Figure 2.) It is the most reliable way to assess the risk for subsequent development of significant hyperbilirubinemia requiring phototherapy.⁹ As such, it is the basis for several online calculators and apps such as BiliTool (bilitool.org).

An alternative nomogram developed by Varvarigou et al¹² is available for predicting significant hyperbilirubinemia based on transcutaneous bilirubin assessment. (Go to https://pdfs.semanticscholar.org/a9a6/5a988dba7a3442bcebc149ad5aea5e3c35d5.pdf and see Figure 3.) The American Academy of Pediatrics (AAP) supports the use of either bilirubin assessment for the screening and diagnosis of hyperbilirubinemia in infants ≥35 weeks’ gestation.⁹

Neurotoxicity risk factors. It is important to differentiate the major and minor risk factors for severe hyperbilirubinemia from neurotoxicity risk factors, also listed in TABLE 3.⁹ Neurotoxicity risk factors are indicative of conditions that may affect albumin binding of bilirubin and are thought to lower the threshold at which bilirubin may cross the blood-brain barrier and render the brain more susceptible to damage from bilirubin. These neurotoxicity risk factors should be applied to the AAP phototherapy nomogram (see Figure 3 at pediatrics.aappublications.org/content/114/1/297) to determine the threshold for initiation of phototherapy in infants with hyperbilirubinemia.⁹

Hyperbilirubinemia is the most common cause of hospital readmission of infants in the United States.

Few investigators have attempted to define risk factors for the development of poor neurologic outcomes associated with hyperbilirubinemia. Evidence to date has not allowed the determination of a specific bilirubin level at which subsequent development of kernicterus occurs.⁹ The limited data available suggest a poor correlation between TSB level and bilirubin-induced neurologic dysfunction.¹³

(For more on kernicterus, as well as ABE and bilirubin-induced neurologic dysfunction [BIND], see “Why do we worry about hyperbilirubinemia?”^9,14-16)

Continue to: Diagnosis relies on TSB and/or TcB

Diagnosis relies on TSB and/or TcB

TSB measurement is the traditional and most widely used method for screening and diagnosing neonatal hyperbilirubinemia, but the blood draw is invasive and carries a risk (albeit low) of infection and anemia.¹⁷ Transcutaneous bilirubin (TcB) assessment is a noninvasive alternative that generally correlates well with TSB values ≤15 mg/dL,^17-20 even in Hispanic, African, and multiethnic populations.^18,21,22

Diagnosis of hyperbilirubinemia is made with TSB or TcB measured at >95th percentile for age in hours. TcB levels measured at >15 mg/dL should be confirmed with TSB measurement. Visual assessment of jaundice should not be used for diagnosis, as it may lead to errors.^9-23

The total cost of testing is lower with TcB ($4-$15 per patient¹⁷) than with TSB when the cost of supplies and personnel are considered.²⁴ Although more recent evidence suggests that TcB is an acceptable way to measure bilirubin in premature infants, no professional society currently recommends the use of TcB for the diagnosis of hyperbilirubinemia in infants²⁵ <35 weeks’ gestation.

Screening recommendations lack consensus

There is a lack of consensus among professional societies on appropriate screening for neonatal hyperbilirubinemia, likely due to limited available data, necessitating expert-driven recommendations.

The AAP recommends universal screening of infants ≥35 weeks’ gestation prior to discharge with measurement of TSB/TcB and/or clinical assessment.⁹ The Canadian Pediatric Society recommends universal screening with TSB/TcB measurement in all infants in the first 72 hours of life.²⁶

Continue to: The US Preventive Services Task Force...

The US Preventative Services Task Force, however, found insufficient evidence to recommend universal screening for infants ≥35 weeks’ gestation.²⁷ The main rationale for their “I” recommendation was that although screening can identify infants at risk of developing severe hyperbilirubinemia, there is no clear evidence that identifying and treating elevated bilirubin levels results in the prevention of kernicterus.

The United Kingdom’s National Institute for Health and Care Excellence (NICE) guidelines do not support universal screening either.²⁸ NICE recommends risk factor assessment and visual inspection for jaundice in all newborns and also additional physical examination for newborns with risk factors. NICE recommends against routine monitoring of bilirubin levels in infants who do not appear jaundiced.

Several recent cohort studies suggest that breastfeeding may not be a significant risk factor for hyperbilirubinemia.

All infants who appear jaundiced should be evaluated with either risk factor assessment or bilirubin measurement (TSB or TcB). Infants born to mothers who are Rh-negative or have type O blood should have cord blood tested for blood type, Rh status, and other antibodies with a direct Coombs test, as ABO and Rh incompatibility are major risk factors for development of hyperbilirubinemia because of hemolysis.^8,9

A question of cost-efficacy? Data from a multicenter prospective clinical trial suggest a number needed to screen of 128,600 to prevent 1 case of kernicterus,²⁹ making cost another important factor in the discussion about screening for neonatal hyperbilirubinemia. Universal screening is associated not only with the cost of TSB and TcB measurements, but also with the cost of phototherapy, rates of which are increased with universal screening.^24,29,30 The cost of caring for 1 patient with kernicterus over a lifetime is estimated at $900,000, while the estimated cost to prevent 1 case of kernicterus with universal TSB/TcB screening is between $5.7 and $9.2 million.³¹

In Canada, universal screening was found to decrease emergency department visits for jaundice, but did not affect rates of readmission for hyperbilirubinemia, length of hospital stay, or rates of phototherapy after discharge.³⁰

Continue to: Phototherapy: What kind of light, when to initiate

Phototherapy: What kind of light, when to initiate

The initial management of hyperbilirubinemia is phototherapy. Light directed at the skin converts bilirubin to lumirubin—a compound that unlike bilirubin does not require conjugation in the liver and can be directly excreted in the urine or bile.⁸

No professional society currently recommends the use of TcB for the diagnosis of hyperbilirubinemia in infants <35 weeks’ gestation.

Light in the blue-green spectrum (460-490 nm) is most effective. Generally, phototherapy is more effective the closer the light is to the infant and the greater the surface area of skin the infant has exposed. There are many different types of lights used to provide phototherapy including fluorescent, halogen, light emitting diode (LED), and fiber optic lights, which are commonly used in home biliblankets.⁸ Fluorescent and halogen lights are the conventional methods, but newer LED systems are equally effective in terms of rate of decline of serum bilirubin levels, duration of phototherapy required, and need for exchange transfusion. Fiber optic lights work as well as other lights in preterm infants but are less effective in term infants. Using 2 fiber optic lights in term infants can increase efficacy to the level of a single conventional or LED source.³²

Phototherapy thresholds. The AAP phototherapy curve (see Figure 3 at http://pediatrics.aappublications.org/content/114/1/297) is commonly used to determine phototherapy thresholds for infants with hyperbilirubinemia. This nomogram applies TSB level and age in hours to a “low,” “medium,” or “high” risk curve that is determined by the presence of neurotoxicity risk factors and gestational age. Infants on the “medium” and “high” risk curves have lower thresholds for initiation of phototherapy.⁹ The majority of infants born at gestational age ≥38 weeks being cared for in a newborn nursery will be assigned to a low risk curve on the AAP phototherapy nomogram, as many of the neurotoxicity risk factors that elevate risk would also be reasons for infants to be in an intensive care unit.

Online calculators and apps based on the AAP phototherapy nomogram, such as BiliTool (bilitool.org), offer recommendations for phototherapy thresholds and may suggest a time interval at which to repeat bilirubin testing if phototherapy is not indicated.

The additional work-up for infants requiring phototherapy often includes neonatal blood type, direct Coombs test, complete blood count and smear, and conjugated bilirubin level.⁹ Besser et al,³³ however, found that 88% of infants requiring phototherapy had normal laboratory results. They also found that those infants with lab abnormalities often started phototherapy before 48 hours of age and did not have an appropriate decrease in bilirubin after initiation of phototherapy.

Continue to: Timing

Timing. Based on this data, it is reasonable to start phototherapy in term infants who develop jaundice at >48 to 72 hours of age without doing additional testing.

Bilirubin levels are expected to drop about 0.5 mg/dL per hour in the first 4 to 8 hours after starting phototherapy, but if the bilirubin measurement is not decreasing as expected or is increasing, additional work-up, with reticulocyte count, G6PD (glucose-6-phosphate dehydrogenase) concentration, end-tidal carbon dioxide determination (ETCO), and a bilirubin/albumin (B/A) ratio is warranted.⁸ Since unbound bilirubin can cross the blood-brain barrier, increased B/A ratio could theoretically be a predictor of bilirubin-induced neurologic dysfunction risk, but Iskander et al³⁴ found that it was not superior to TSB levels in predicting neurotoxicity. ETCO may help identify children with ongoing hemolysis.⁸

The ideal time to stop phototherapy is not clear. Expert recommendations for phototherapy discontinuation thresholds range from 4-5 mg/dL to 13-14 mg/dL,⁸ while other clinicians stop phototherapy when bilirubin falls 1 to 2 mg/dL below the phototherapy initiation threshold. Phototherapy should be continued for any infant with signs of acute bilirubin encephalopathy, even if the bilirubin level is decreasing.⁹ Rebound hyperbilirubinemia is rare, and checking rebound bilirubin levels is not recommended.⁸

Safety. Phototherapy is generally considered safe, but both short- and long-term adverse effects are possible. Immediate adverse effects include intestinal hypermobility/diarrhea and temperature instability. Long-term issues include increased risks of the development of childhood asthma (odds ratio=1.4) and type 1 diabetes (odds ratio=3.79).³⁵ Phototherapy can also be distressing for parents, as it requires frequent blood draws, physical separation, and possible disruption of breastfeeding.³⁶ One study found a number needed to harm of 4 for cessation of breastfeeding at 1 month in jaundiced infants.³⁷

Maintain breastfeeding. The AAP recommends breastfeeding be continued and promoted in infants who are jaundiced and receiving phototherapy.⁹ Maternal interaction with health care professionals who are encouraging of this practice was the best predictor of ongoing breastfeeding in a qualitative study of jaundiced infants and their families.³⁸ Interrupting phototherapy for up to 30 minutes to allow for breastfeeding without eye covers has not been shown to decrease the efficacy of phototherapy.³⁸

Continue to: Available evidence does not provide a clear answer...

Available evidence does not provide a clear answer regarding whether formula supplementation should be initiated in breastfed infants with hyperbilirubinemia. Cow’s milk formula supplementation decreases intestinal reabsorption of bilirubin, lowering serum bilirubin levels, but may interfere with successful breastfeeding.³⁹ The Academy of Breastfeeding Medicine recommends an individual discussion about formula supplementation in place of, or prior to, phototherapy if an infant’s bilirubin is approaching (within 2-3 mg/dL) or above the threshold for phototherapy.³⁹ Routine supplementation with intravenous fluids or other non–milk-based supplementation is not recommended for infants receiving phototherapy.⁹

Adjuvant therapies and exchange transfusion

Clofibrate, metalloporphyrins, and ursodiol have been studied in the management of unconjugated hyperbilirubinemia as augmentation to phototherapy. Honar et al⁴⁰ found that ursodiol added at the time of phototherapy initiation demonstrated a significant reduction in peak bilirubin levels and duration of phototherapy in term infants with unconjugated hyperbilirubinemia without any adverse effects. Cochrane reviews of clofibrat⁵ and metalloporphyrins⁴¹ found that when added to phototherapy, these medications significantly decreased serum bilirubin levels and duration of phototherapy. However, there was insufficient evidence to recommend their use due to inadequate data on safety and long-term outcomes.

Exchange transfusion. Infants with bilirubin levels >25 mg/dL, those who are not responding to phototherapy, and those with evidence of acute bilirubin encephalopathy should be treated with exchange transfusion, with initiation based on an infant’s age in hours and neurotoxicity risk factors.⁹ Exchange transfusion involves taking small aliquots of blood from the infant and replacing them with donor red cells until the infant’s blood volume has been replaced twice to remove bilirubin and antibodies that may be causing hemolysis. It should be carried out in a neonatal intensive care unit due to significant risks.

About 88% of infants requiring phototherapy have normal laboratory study results.

Approximately 12% of infants have a complication from exchange transfusion including infection, electrolyte imbalances, thrombosis, thrombocytopenia, and necrotizing enterocolitis.⁸ The mortality rate in neonates without hemolysis who undergo exchange transfusion is 3 to 4 per 1000 treated.⁴²

Post-discharge follow-up

Infants discharged before 72 hours of life should be seen within 2 days of discharge. Those infants with significant risk factors for development of severe hyperbilirubinemia should be seen within 1 day. Arrangements for follow-up should be made prior to discharge. Some infants discharged before 48 hours of life may require 2 follow-up visits. If follow-up cannot be ensured for an infant with risk factors for the development of severe hyperbilirubinemia, delay of discharge may be appropriate.⁹

CORRESPONDENCE
Katharine C. DeGeorge, MD, MS, Department of Family Medicine, University of Virginia, PO Box 800729, Charlottesville, VA, 22908-0729; kd6fp@virginia.edu.

BROOKLYN, N.Y. – There are studies demonstrating depression is more likely to resolve if depressed parents are also treated dating back more than 10 years, but new evidence suggests this effect may extend to children as young as 3 years of age, according to an update on current strategies for early intervention presented at a pediatric psychopharmacology update held by the American Academy of Child and Adolescent Psychiatry.

Of multiple triggers that can be caught and treated early to prevent children from progressing to chronic depression, addressing parental depression is an important target, according to Karen Dineen Wagner, MD, Director of the Division of Child and Adolescent Psychiatry at the University of Texas Medical Branch in Galveston.

In an overview of strategies for intervening early in children who have or are at risk for depression, Dr. Wagner looked at several targets. The purpose of recognizing and addressing such targets as parental depression is to get children well faster and avoid disease chronicity.

“If we want to intervene and potentially prevent the occurrence of depression, we need to look at disorders or triggers that may precede the depression and that, had they been treated, might have eliminated the stressors that tip the child into depression,” Dr. Wagner said.

Parental depression was just one of these factors, but along with others, such as child abuse of any kind and bullying, each poses a threat for chronic mood disorders, according to Dr. Wagner.

In the case of parental depression, Dr. Wagner cited numerous studies demonstrating a close correlation between remission in the parent and remission in the child. These trajectories interact, so children are less likely to get well if an affected parent does not get well.

“Make sure you consider depression in the parent when you are doing an evaluation, and it is not just depression in the parent who is there. Ask about the other partner who is not there,” Dr. Wagner advised. Parents reluctant to address their own depression should be informed that the mental health of their child is at risk.

The most recent evidence to show benefit from treating both child and parent was drawn from a controlled study that enrolled young children (Luby JL et al. Am J Psychiatry. 2018 Jun 20. doi: 10.1176/appi.ajp.2018.18030321).

In this study, 229 parent-child dyads were randomized to receive parent-child psychotherapy for early childhood depression or to a wait-list. The age range for the children was 3-6.2 years. The therapy was specifically designed to improve the parents’ ability to help young children cope with their feelings.

The parent-child interaction therapy “focused on emotional development which was designed to train parents to work with the child on developing emotional competence in which the child understands their emotions, understands how events affect how they are feeling, and controls emotional reactivity,” Dr. Wagner explained.

For the primary outcome of depression at the end of 18 weeks, the rates were significantly lower in those who participated in the interaction therapy than they were in those on the wait-list. Measures of parent depression and stress were also lower in the therapy group.

Currently, the U. S. Preventive Task Force recommends screening all children at age 12 for depression with the adolescent version of the Patient Health Questionnaire (PHQ-A), according to Dr. Wagner. Given the rising prevalence of depression in adolescents, which climbed 46% from 2005 (8.7%) to 2015 (12.7%) according to a published national survey, this screening is prudent, Dr. Wagner indicated. However, she further suggested that it is reasonable to screen children with risk factors, such as learning disorders or anxiety disorders, even earlier.

The reason is that there are effective therapies. Early treatment may prevent chronic and more severe forms of depression, according to Dr. Wagner. She suggested that there is a growing emphasis on not just treating depression at its early stages but also in recognizing the child at risk, identifying subsyndromal symptoms leading toward depression, and preventing children from ever reaching diagnostic criteria.

Indeed, an initiative for better and earlier detection and treatment of depression in children was begun by the AACAP when Dr. Wagner served recently as its president. Several parts of that program have now been launched. Dr. Wagner encouraged those with an interest to visit the AACAP website, where more information about this initiative can be accessed.

Dr. Wagner reported no potential conflicts of interest.

BROOKLYN, N.Y. – There are studies demonstrating depression is more likely to resolve if depressed parents are also treated dating back more than 10 years, but new evidence suggests this effect may extend to children as young as 3 years of age, according to an update on current strategies for early intervention presented at a pediatric psychopharmacology update held by the American Academy of Child and Adolescent Psychiatry.

Of multiple triggers that can be caught and treated early to prevent children from progressing to chronic depression, addressing parental depression is an important target, according to Karen Dineen Wagner, MD, Director of the Division of Child and Adolescent Psychiatry at the University of Texas Medical Branch in Galveston.

In an overview of strategies for intervening early in children who have or are at risk for depression, Dr. Wagner looked at several targets. The purpose of recognizing and addressing such targets as parental depression is to get children well faster and avoid disease chronicity.

“If we want to intervene and potentially prevent the occurrence of depression, we need to look at disorders or triggers that may precede the depression and that, had they been treated, might have eliminated the stressors that tip the child into depression,” Dr. Wagner said.

Parental depression was just one of these factors, but along with others, such as child abuse of any kind and bullying, each poses a threat for chronic mood disorders, according to Dr. Wagner.

In the case of parental depression, Dr. Wagner cited numerous studies demonstrating a close correlation between remission in the parent and remission in the child. These trajectories interact, so children are less likely to get well if an affected parent does not get well.

“Make sure you consider depression in the parent when you are doing an evaluation, and it is not just depression in the parent who is there. Ask about the other partner who is not there,” Dr. Wagner advised. Parents reluctant to address their own depression should be informed that the mental health of their child is at risk.

The most recent evidence to show benefit from treating both child and parent was drawn from a controlled study that enrolled young children (Luby JL et al. Am J Psychiatry. 2018 Jun 20. doi: 10.1176/appi.ajp.2018.18030321).

In this study, 229 parent-child dyads were randomized to receive parent-child psychotherapy for early childhood depression or to a wait-list. The age range for the children was 3-6.2 years. The therapy was specifically designed to improve the parents’ ability to help young children cope with their feelings.

The parent-child interaction therapy “focused on emotional development which was designed to train parents to work with the child on developing emotional competence in which the child understands their emotions, understands how events affect how they are feeling, and controls emotional reactivity,” Dr. Wagner explained.

For the primary outcome of depression at the end of 18 weeks, the rates were significantly lower in those who participated in the interaction therapy than they were in those on the wait-list. Measures of parent depression and stress were also lower in the therapy group.

Currently, the U. S. Preventive Task Force recommends screening all children at age 12 for depression with the adolescent version of the Patient Health Questionnaire (PHQ-A), according to Dr. Wagner. Given the rising prevalence of depression in adolescents, which climbed 46% from 2005 (8.7%) to 2015 (12.7%) according to a published national survey, this screening is prudent, Dr. Wagner indicated. However, she further suggested that it is reasonable to screen children with risk factors, such as learning disorders or anxiety disorders, even earlier.

The reason is that there are effective therapies. Early treatment may prevent chronic and more severe forms of depression, according to Dr. Wagner. She suggested that there is a growing emphasis on not just treating depression at its early stages but also in recognizing the child at risk, identifying subsyndromal symptoms leading toward depression, and preventing children from ever reaching diagnostic criteria.

Indeed, an initiative for better and earlier detection and treatment of depression in children was begun by the AACAP when Dr. Wagner served recently as its president. Several parts of that program have now been launched. Dr. Wagner encouraged those with an interest to visit the AACAP website, where more information about this initiative can be accessed.

Dr. Wagner reported no potential conflicts of interest.

BROOKLYN, N.Y. – There are studies demonstrating depression is more likely to resolve if depressed parents are also treated dating back more than 10 years, but new evidence suggests this effect may extend to children as young as 3 years of age, according to an update on current strategies for early intervention presented at a pediatric psychopharmacology update held by the American Academy of Child and Adolescent Psychiatry.

Of multiple triggers that can be caught and treated early to prevent children from progressing to chronic depression, addressing parental depression is an important target, according to Karen Dineen Wagner, MD, Director of the Division of Child and Adolescent Psychiatry at the University of Texas Medical Branch in Galveston.

In an overview of strategies for intervening early in children who have or are at risk for depression, Dr. Wagner looked at several targets. The purpose of recognizing and addressing such targets as parental depression is to get children well faster and avoid disease chronicity.

“If we want to intervene and potentially prevent the occurrence of depression, we need to look at disorders or triggers that may precede the depression and that, had they been treated, might have eliminated the stressors that tip the child into depression,” Dr. Wagner said.

Parental depression was just one of these factors, but along with others, such as child abuse of any kind and bullying, each poses a threat for chronic mood disorders, according to Dr. Wagner.

In the case of parental depression, Dr. Wagner cited numerous studies demonstrating a close correlation between remission in the parent and remission in the child. These trajectories interact, so children are less likely to get well if an affected parent does not get well.

“Make sure you consider depression in the parent when you are doing an evaluation, and it is not just depression in the parent who is there. Ask about the other partner who is not there,” Dr. Wagner advised. Parents reluctant to address their own depression should be informed that the mental health of their child is at risk.

The most recent evidence to show benefit from treating both child and parent was drawn from a controlled study that enrolled young children (Luby JL et al. Am J Psychiatry. 2018 Jun 20. doi: 10.1176/appi.ajp.2018.18030321).

In this study, 229 parent-child dyads were randomized to receive parent-child psychotherapy for early childhood depression or to a wait-list. The age range for the children was 3-6.2 years. The therapy was specifically designed to improve the parents’ ability to help young children cope with their feelings.

The parent-child interaction therapy “focused on emotional development which was designed to train parents to work with the child on developing emotional competence in which the child understands their emotions, understands how events affect how they are feeling, and controls emotional reactivity,” Dr. Wagner explained.

For the primary outcome of depression at the end of 18 weeks, the rates were significantly lower in those who participated in the interaction therapy than they were in those on the wait-list. Measures of parent depression and stress were also lower in the therapy group.

Currently, the U. S. Preventive Task Force recommends screening all children at age 12 for depression with the adolescent version of the Patient Health Questionnaire (PHQ-A), according to Dr. Wagner. Given the rising prevalence of depression in adolescents, which climbed 46% from 2005 (8.7%) to 2015 (12.7%) according to a published national survey, this screening is prudent, Dr. Wagner indicated. However, she further suggested that it is reasonable to screen children with risk factors, such as learning disorders or anxiety disorders, even earlier.

The reason is that there are effective therapies. Early treatment may prevent chronic and more severe forms of depression, according to Dr. Wagner. She suggested that there is a growing emphasis on not just treating depression at its early stages but also in recognizing the child at risk, identifying subsyndromal symptoms leading toward depression, and preventing children from ever reaching diagnostic criteria.

Indeed, an initiative for better and earlier detection and treatment of depression in children was begun by the AACAP when Dr. Wagner served recently as its president. Several parts of that program have now been launched. Dr. Wagner encouraged those with an interest to visit the AACAP website, where more information about this initiative can be accessed.

Dr. Wagner reported no potential conflicts of interest.

Most parents are unaware their teenager has been having suicidal thoughts or thinking about death, according to a study published in Pediatrics.

asiseeit/E+/Getty Images

Jason D. Jones, PhD, from the Children’s Hospital of Philadelphia, and his coauthors wrote that more than two-thirds of adolescents who experience suicidal thoughts do not get medical help, and this may be because their parents – the gatekeepers for mental health services – are unaware of what their teen is going through.

In this study, researchers recruited 5,137 adolescents aged 11-17 years and either a parent or step-parent, and interviewed both about the adolescent’s lifetime suicidal thoughts.

While 413 (8%) of the adolescents surveyed said they had had thoughts about killing themselves, 50% of those adolescents’ parents said their teen hadn’t experienced suicidal thoughts. Similarly, 786 (15%) of adolescents surveyed said they had had thoughts about death and dying, but three-quarters of their parents were unaware.

A significant number of parents – 8% – said their teenager had had suicidal thoughts, but in 48% of these cases, the teenager said they had not thought about killing themselves.

Researchers saw more agreement between parents and adolescents when the adolescents were older: The parents were less likely to be unaware that their older teen had had suicidal thoughts, and older adolescents were less likely to deny it.

“This indicates that younger adolescents may be more likely to go unnoticed and not receive services either because their parents are unaware of their suicidal thoughts or because they deny suicidal thoughts that their parents think they are having,” Dr. Jones and his associates wrote. They also suggested younger adolescents may have “interpretive difficulties” around questions of suicidal ideation.

“These age findings are particularly noteworthy in light of recent evidence that deaths by suicide have increased among younger adolescents,” they noted.

There also was an interaction between age and gender. For girls, parents were less likely to be aware of suicidal thoughts in their younger daughters but more likely to be aware of them in their older daughters. However the opposite was true for boys: Parental unawareness increased slightly in older boys.

Parents of Hispanic or Latino ethnicity were less likely to be aware that their offspring had had thoughts about death and dying.

Generally fathers were less likely than mothers to be aware of suicidal thoughts in their adolescents.

However, if adolescents had previously received psychiatric treatment, or there was a family history of suicide, parents were more likely to be aware of suicidal thoughts, and adolescents who had a history of psychiatric hospitalization were less likely to deny suicidal thoughts, the researchers reported.

The study was supported by grants from the National Institutes of Health, the Dowshen Program for Neuroscience, and the Lifespan Brain Institute of the Children’s Hospital of Philadelphia and University of Pennsylvania. The study was funded by NIH. One author declared a board position and stock options in Taliaz Health unrelated to the study subject; the other authors said they had no relevant financial disclosures.

SOURCE: Jones JD et al. Pediatrics. 2019 Jan 14. doi: 10.1542/peds.2018-1771.
 

Most parents are unaware their teenager has been having suicidal thoughts or thinking about death, according to a study published in Pediatrics.

asiseeit/E+/Getty Images

Jason D. Jones, PhD, from the Children’s Hospital of Philadelphia, and his coauthors wrote that more than two-thirds of adolescents who experience suicidal thoughts do not get medical help, and this may be because their parents – the gatekeepers for mental health services – are unaware of what their teen is going through.

In this study, researchers recruited 5,137 adolescents aged 11-17 years and either a parent or step-parent, and interviewed both about the adolescent’s lifetime suicidal thoughts.

While 413 (8%) of the adolescents surveyed said they had had thoughts about killing themselves, 50% of those adolescents’ parents said their teen hadn’t experienced suicidal thoughts. Similarly, 786 (15%) of adolescents surveyed said they had had thoughts about death and dying, but three-quarters of their parents were unaware.

A significant number of parents – 8% – said their teenager had had suicidal thoughts, but in 48% of these cases, the teenager said they had not thought about killing themselves.

Researchers saw more agreement between parents and adolescents when the adolescents were older: The parents were less likely to be unaware that their older teen had had suicidal thoughts, and older adolescents were less likely to deny it.

“This indicates that younger adolescents may be more likely to go unnoticed and not receive services either because their parents are unaware of their suicidal thoughts or because they deny suicidal thoughts that their parents think they are having,” Dr. Jones and his associates wrote. They also suggested younger adolescents may have “interpretive difficulties” around questions of suicidal ideation.

“These age findings are particularly noteworthy in light of recent evidence that deaths by suicide have increased among younger adolescents,” they noted.

There also was an interaction between age and gender. For girls, parents were less likely to be aware of suicidal thoughts in their younger daughters but more likely to be aware of them in their older daughters. However the opposite was true for boys: Parental unawareness increased slightly in older boys.

Parents of Hispanic or Latino ethnicity were less likely to be aware that their offspring had had thoughts about death and dying.

Generally fathers were less likely than mothers to be aware of suicidal thoughts in their adolescents.

However, if adolescents had previously received psychiatric treatment, or there was a family history of suicide, parents were more likely to be aware of suicidal thoughts, and adolescents who had a history of psychiatric hospitalization were less likely to deny suicidal thoughts, the researchers reported.

The study was supported by grants from the National Institutes of Health, the Dowshen Program for Neuroscience, and the Lifespan Brain Institute of the Children’s Hospital of Philadelphia and University of Pennsylvania. The study was funded by NIH. One author declared a board position and stock options in Taliaz Health unrelated to the study subject; the other authors said they had no relevant financial disclosures.

SOURCE: Jones JD et al. Pediatrics. 2019 Jan 14. doi: 10.1542/peds.2018-1771.
 

Most parents are unaware their teenager has been having suicidal thoughts or thinking about death, according to a study published in Pediatrics.

asiseeit/E+/Getty Images

Jason D. Jones, PhD, from the Children’s Hospital of Philadelphia, and his coauthors wrote that more than two-thirds of adolescents who experience suicidal thoughts do not get medical help, and this may be because their parents – the gatekeepers for mental health services – are unaware of what their teen is going through.

In this study, researchers recruited 5,137 adolescents aged 11-17 years and either a parent or step-parent, and interviewed both about the adolescent’s lifetime suicidal thoughts.

While 413 (8%) of the adolescents surveyed said they had had thoughts about killing themselves, 50% of those adolescents’ parents said their teen hadn’t experienced suicidal thoughts. Similarly, 786 (15%) of adolescents surveyed said they had had thoughts about death and dying, but three-quarters of their parents were unaware.

A significant number of parents – 8% – said their teenager had had suicidal thoughts, but in 48% of these cases, the teenager said they had not thought about killing themselves.

Researchers saw more agreement between parents and adolescents when the adolescents were older: The parents were less likely to be unaware that their older teen had had suicidal thoughts, and older adolescents were less likely to deny it.

“This indicates that younger adolescents may be more likely to go unnoticed and not receive services either because their parents are unaware of their suicidal thoughts or because they deny suicidal thoughts that their parents think they are having,” Dr. Jones and his associates wrote. They also suggested younger adolescents may have “interpretive difficulties” around questions of suicidal ideation.

“These age findings are particularly noteworthy in light of recent evidence that deaths by suicide have increased among younger adolescents,” they noted.

There also was an interaction between age and gender. For girls, parents were less likely to be aware of suicidal thoughts in their younger daughters but more likely to be aware of them in their older daughters. However the opposite was true for boys: Parental unawareness increased slightly in older boys.

Parents of Hispanic or Latino ethnicity were less likely to be aware that their offspring had had thoughts about death and dying.

Generally fathers were less likely than mothers to be aware of suicidal thoughts in their adolescents.

However, if adolescents had previously received psychiatric treatment, or there was a family history of suicide, parents were more likely to be aware of suicidal thoughts, and adolescents who had a history of psychiatric hospitalization were less likely to deny suicidal thoughts, the researchers reported.

The study was supported by grants from the National Institutes of Health, the Dowshen Program for Neuroscience, and the Lifespan Brain Institute of the Children’s Hospital of Philadelphia and University of Pennsylvania. The study was funded by NIH. One author declared a board position and stock options in Taliaz Health unrelated to the study subject; the other authors said they had no relevant financial disclosures.

SOURCE: Jones JD et al. Pediatrics. 2019 Jan 14. doi: 10.1542/peds.2018-1771.
 

The Food and Drug Administration has approved the 0.5-mL dosage of Fluzone Quadrivalent, an influenza vaccine, for use in children aged 6-35 months, according to Sanofi Pasteur, the vaccine’s manufacturer.

FDA approval was based on results of a phase 4 safety and immunogenicity study of nearly 2,000 children. Children aged 6-35 months who received one or two doses of Fluzone at 0.50 mL had a safety profile similar to that of children who received one or two doses of Fluzone at 0.25 mL. Results from the study were presented at the Pediatric Academic Societies annual meeting in April 2018.

This flu vaccine should not be given to anyone with a severe allergic reaction (anaphylaxis) to egg or egg products, according to the press release.

In children, the most common adverse events are injection site reactions, muscle aches, fatigue, and headache; in young children, irritability, abnormal crying, drowsiness, appetite loss, vomiting, and fever are common.

“Offering pediatricians the convenience of the same 0.5-mL dose option for children may help streamline immunization efforts. The potentially life-threatening effects of influenza in children reported during the 2017-18 season, especially among those who were not vaccinated, is sobering,” David P. Greenberg, MD, regional medical head of Sanofi Pasteur of North America, said in the press release.

Find the full press release on the Sanofi website.

lfranki@mdedge.com

The Food and Drug Administration has approved the 0.5-mL dosage of Fluzone Quadrivalent, an influenza vaccine, for use in children aged 6-35 months, according to Sanofi Pasteur, the vaccine’s manufacturer.

FDA approval was based on results of a phase 4 safety and immunogenicity study of nearly 2,000 children. Children aged 6-35 months who received one or two doses of Fluzone at 0.50 mL had a safety profile similar to that of children who received one or two doses of Fluzone at 0.25 mL. Results from the study were presented at the Pediatric Academic Societies annual meeting in April 2018.

This flu vaccine should not be given to anyone with a severe allergic reaction (anaphylaxis) to egg or egg products, according to the press release.

In children, the most common adverse events are injection site reactions, muscle aches, fatigue, and headache; in young children, irritability, abnormal crying, drowsiness, appetite loss, vomiting, and fever are common.

“Offering pediatricians the convenience of the same 0.5-mL dose option for children may help streamline immunization efforts. The potentially life-threatening effects of influenza in children reported during the 2017-18 season, especially among those who were not vaccinated, is sobering,” David P. Greenberg, MD, regional medical head of Sanofi Pasteur of North America, said in the press release.

Find the full press release on the Sanofi website.

lfranki@mdedge.com

The Food and Drug Administration has approved the 0.5-mL dosage of Fluzone Quadrivalent, an influenza vaccine, for use in children aged 6-35 months, according to Sanofi Pasteur, the vaccine’s manufacturer.

FDA approval was based on results of a phase 4 safety and immunogenicity study of nearly 2,000 children. Children aged 6-35 months who received one or two doses of Fluzone at 0.50 mL had a safety profile similar to that of children who received one or two doses of Fluzone at 0.25 mL. Results from the study were presented at the Pediatric Academic Societies annual meeting in April 2018.

This flu vaccine should not be given to anyone with a severe allergic reaction (anaphylaxis) to egg or egg products, according to the press release.

In children, the most common adverse events are injection site reactions, muscle aches, fatigue, and headache; in young children, irritability, abnormal crying, drowsiness, appetite loss, vomiting, and fever are common.

“Offering pediatricians the convenience of the same 0.5-mL dose option for children may help streamline immunization efforts. The potentially life-threatening effects of influenza in children reported during the 2017-18 season, especially among those who were not vaccinated, is sobering,” David P. Greenberg, MD, regional medical head of Sanofi Pasteur of North America, said in the press release.

Find the full press release on the Sanofi website.

lfranki@mdedge.com

In what is believed to be the first study of its kind to compare all available pharmacologic treatment options for relief of symptoms associated with neonatal abstinence syndrome (NAS), buprenorphine has the greatest probability of reducing duration of treatment and length of stay among newborns, reported Timothy Disher, PhD, of Dalhousie University School of Nursing, Halifax, N.S., and his associates.

Courtesy UNC Children&#039;s Hospital

It was noteworthy that the study also found morphine and phenobarbital monotherapies to be worst in overall effectiveness and ranking because these pharmacotherapies are the most frequently used treatments in the United States, according to the authors. Dr. Disher and his associates underscored the need for concern over the common rationale of treatment centers, especially in using phenobarbital, since the American Academy of Pediatrics “highlights that phenobarbital is most commonly used only as adjuvant therapy” and was not intended as a first-line treatment.

In their efforts to identify treatments that are most effective at easing the symptoms of NAS, Dr. Disher and his colleagues conducted a systematic review and network meta-analysis in June 2018, which included a search of the Cochrane Central Register of Controlled Trials, Ovid MEDLINE, Embase, and the Web of Science Core Collection. In addition, they referenced ClinicalTrials.gov to identify relevant ongoing trials. Studies ultimately included in the review were randomized clinical trials comparing at least two pharmacotherapies prescribed for NAS that had been published in peer-reviewed journals.

Eighteen studies examining treatment for NAS among 1,072 newborns, including 10 studies published since 2000, were identified; the remaining studies were published between 1977 and 1986. Altogether, eight treatment interventions were examined across 10 studies

Dr. Disher and his associates reported that, during 2004-2014, there was a fivefold increase in the number of babies presenting with NAS, from 1.5/1,000 live births to 8.0/1,000, which represented a sevenfold increase in treatment cost in the Medicaid population during the same period, from $65.4 million to $462 million.

Although Dr. Disher and his colleagues acknowledged that buprenorphine was identified as best treatment by median ranks, “the ranks for most treatments are imprecise,” they said. According to results of their analysis, buprenorphine was associated with a reduction in 2.19 days of treatment, compared with clonidine, and 12.75 days, compared with morphine. In terms of secondary outcomes, buprenorphine was associated with a reduction in length of stay of 5.35 days, compared with clonidine, and 11.43 days, compared with morphine.

Seven of the studies evaluated (n = 394) included infants requiring adjuvant treatment. Agthe et al. reported that no infants in the concomitant diluted tincture of opium (DTO) and clonidine arm needed adjuvant treatment compared with five infants in the DTO-only arm who did. Surran et al. reported 2 of 32 infants who failed attempts to wean in the concomitant morphine and clonidine group compared with none of the 34 who were in the morphine and phenobarbital group.

In terms of adverse events, one study reported a seizure that was unrelated to treatment (Kraft et al). Agthe et al. reported three infants experiencing seizure in the DTO-only group compared with no infants who received concomitant clonidine. In Surran et al., three infants receiving concomitant phenobarbital and morphine were reported to be oversedated.

In general, the rationale explaining differences in why pharmacologic therapies affect treatment length is underdeveloped, the authors said. Buprenorphine, in particular, is favored because of its ease of dosing schedule and the possible improved safety profile given its longer half-life and greater micro-opioid receptor activity. It has been further suggested that the prolonged half-life of buprenorphine may be responsible for preventing sudden withdrawal symptoms. The researchers found no significant adverse events associated with buprenorphine treatment.

Although there were differences across buprenorphine treatment protocols, Dr. Disher and his colleagues noted that they were “broadly similar.” The authors conceded, however, that there is reason to question “how much of the observed improvement in buprenorphine may be attributable to the differences in optimization of the treatment and weaning protocols.”

Based on findings in this review, the authors caution that it is unlikely “that the current evidence base is sufficient to recommend specific large-scale changes in treatment away from the current standard of care.”

Despite recent research, which proposes trying nonpharmacologic treatments first and incorporating shared rooms for families and infants to reduce length of stay when treatment is required, up to 70% of infants ultimately require pharmacologic treatment. When drug therapy is needed, the average length of stay and overall treatment costs double, 10.9 vs. 22 days and $20,708 vs. $44,720, respectively.

Since results of the analysis show benefit, however variable, in reducing the length of treatment, “continued efforts to identify the optimal pharmacological agents are justified,” urged Dr. Disher and his associates.

Ultimately, before buprenorphine can be considered as a universally accepted standard of care in the treatment of NAS, “a large multisite pragmatic trial that compares buprenorphine with other treatments” will be needed.

One of the researchers – Chris Cameron, PhD – is an employee and holds shares of the Cornerstone Research Group, which provides consultant services to various pharmaceutical and device companies. Dr. Disher is a subcontractor for the Cornerstone Research Group. There were no other disclosures to report.

SOURCE: Disher T et al. JAMA Pediatr. 2019. doi: 10.1001/jamapediatrics.2018.5044.

In what is believed to be the first study of its kind to compare all available pharmacologic treatment options for relief of symptoms associated with neonatal abstinence syndrome (NAS), buprenorphine has the greatest probability of reducing duration of treatment and length of stay among newborns, reported Timothy Disher, PhD, of Dalhousie University School of Nursing, Halifax, N.S., and his associates.

Courtesy UNC Children&#039;s Hospital

It was noteworthy that the study also found morphine and phenobarbital monotherapies to be worst in overall effectiveness and ranking because these pharmacotherapies are the most frequently used treatments in the United States, according to the authors. Dr. Disher and his associates underscored the need for concern over the common rationale of treatment centers, especially in using phenobarbital, since the American Academy of Pediatrics “highlights that phenobarbital is most commonly used only as adjuvant therapy” and was not intended as a first-line treatment.

In their efforts to identify treatments that are most effective at easing the symptoms of NAS, Dr. Disher and his colleagues conducted a systematic review and network meta-analysis in June 2018, which included a search of the Cochrane Central Register of Controlled Trials, Ovid MEDLINE, Embase, and the Web of Science Core Collection. In addition, they referenced ClinicalTrials.gov to identify relevant ongoing trials. Studies ultimately included in the review were randomized clinical trials comparing at least two pharmacotherapies prescribed for NAS that had been published in peer-reviewed journals.

Eighteen studies examining treatment for NAS among 1,072 newborns, including 10 studies published since 2000, were identified; the remaining studies were published between 1977 and 1986. Altogether, eight treatment interventions were examined across 10 studies

Dr. Disher and his associates reported that, during 2004-2014, there was a fivefold increase in the number of babies presenting with NAS, from 1.5/1,000 live births to 8.0/1,000, which represented a sevenfold increase in treatment cost in the Medicaid population during the same period, from $65.4 million to $462 million.

Although Dr. Disher and his colleagues acknowledged that buprenorphine was identified as best treatment by median ranks, “the ranks for most treatments are imprecise,” they said. According to results of their analysis, buprenorphine was associated with a reduction in 2.19 days of treatment, compared with clonidine, and 12.75 days, compared with morphine. In terms of secondary outcomes, buprenorphine was associated with a reduction in length of stay of 5.35 days, compared with clonidine, and 11.43 days, compared with morphine.

Seven of the studies evaluated (n = 394) included infants requiring adjuvant treatment. Agthe et al. reported that no infants in the concomitant diluted tincture of opium (DTO) and clonidine arm needed adjuvant treatment compared with five infants in the DTO-only arm who did. Surran et al. reported 2 of 32 infants who failed attempts to wean in the concomitant morphine and clonidine group compared with none of the 34 who were in the morphine and phenobarbital group.

In terms of adverse events, one study reported a seizure that was unrelated to treatment (Kraft et al). Agthe et al. reported three infants experiencing seizure in the DTO-only group compared with no infants who received concomitant clonidine. In Surran et al., three infants receiving concomitant phenobarbital and morphine were reported to be oversedated.

In general, the rationale explaining differences in why pharmacologic therapies affect treatment length is underdeveloped, the authors said. Buprenorphine, in particular, is favored because of its ease of dosing schedule and the possible improved safety profile given its longer half-life and greater micro-opioid receptor activity. It has been further suggested that the prolonged half-life of buprenorphine may be responsible for preventing sudden withdrawal symptoms. The researchers found no significant adverse events associated with buprenorphine treatment.

Although there were differences across buprenorphine treatment protocols, Dr. Disher and his colleagues noted that they were “broadly similar.” The authors conceded, however, that there is reason to question “how much of the observed improvement in buprenorphine may be attributable to the differences in optimization of the treatment and weaning protocols.”

Based on findings in this review, the authors caution that it is unlikely “that the current evidence base is sufficient to recommend specific large-scale changes in treatment away from the current standard of care.”

Despite recent research, which proposes trying nonpharmacologic treatments first and incorporating shared rooms for families and infants to reduce length of stay when treatment is required, up to 70% of infants ultimately require pharmacologic treatment. When drug therapy is needed, the average length of stay and overall treatment costs double, 10.9 vs. 22 days and $20,708 vs. $44,720, respectively.

Since results of the analysis show benefit, however variable, in reducing the length of treatment, “continued efforts to identify the optimal pharmacological agents are justified,” urged Dr. Disher and his associates.

Ultimately, before buprenorphine can be considered as a universally accepted standard of care in the treatment of NAS, “a large multisite pragmatic trial that compares buprenorphine with other treatments” will be needed.

One of the researchers – Chris Cameron, PhD – is an employee and holds shares of the Cornerstone Research Group, which provides consultant services to various pharmaceutical and device companies. Dr. Disher is a subcontractor for the Cornerstone Research Group. There were no other disclosures to report.

SOURCE: Disher T et al. JAMA Pediatr. 2019. doi: 10.1001/jamapediatrics.2018.5044.

In what is believed to be the first study of its kind to compare all available pharmacologic treatment options for relief of symptoms associated with neonatal abstinence syndrome (NAS), buprenorphine has the greatest probability of reducing duration of treatment and length of stay among newborns, reported Timothy Disher, PhD, of Dalhousie University School of Nursing, Halifax, N.S., and his associates.

Courtesy UNC Children&#039;s Hospital

It was noteworthy that the study also found morphine and phenobarbital monotherapies to be worst in overall effectiveness and ranking because these pharmacotherapies are the most frequently used treatments in the United States, according to the authors. Dr. Disher and his associates underscored the need for concern over the common rationale of treatment centers, especially in using phenobarbital, since the American Academy of Pediatrics “highlights that phenobarbital is most commonly used only as adjuvant therapy” and was not intended as a first-line treatment.

In their efforts to identify treatments that are most effective at easing the symptoms of NAS, Dr. Disher and his colleagues conducted a systematic review and network meta-analysis in June 2018, which included a search of the Cochrane Central Register of Controlled Trials, Ovid MEDLINE, Embase, and the Web of Science Core Collection. In addition, they referenced ClinicalTrials.gov to identify relevant ongoing trials. Studies ultimately included in the review were randomized clinical trials comparing at least two pharmacotherapies prescribed for NAS that had been published in peer-reviewed journals.

Eighteen studies examining treatment for NAS among 1,072 newborns, including 10 studies published since 2000, were identified; the remaining studies were published between 1977 and 1986. Altogether, eight treatment interventions were examined across 10 studies

Dr. Disher and his associates reported that, during 2004-2014, there was a fivefold increase in the number of babies presenting with NAS, from 1.5/1,000 live births to 8.0/1,000, which represented a sevenfold increase in treatment cost in the Medicaid population during the same period, from $65.4 million to $462 million.

Although Dr. Disher and his colleagues acknowledged that buprenorphine was identified as best treatment by median ranks, “the ranks for most treatments are imprecise,” they said. According to results of their analysis, buprenorphine was associated with a reduction in 2.19 days of treatment, compared with clonidine, and 12.75 days, compared with morphine. In terms of secondary outcomes, buprenorphine was associated with a reduction in length of stay of 5.35 days, compared with clonidine, and 11.43 days, compared with morphine.

Seven of the studies evaluated (n = 394) included infants requiring adjuvant treatment. Agthe et al. reported that no infants in the concomitant diluted tincture of opium (DTO) and clonidine arm needed adjuvant treatment compared with five infants in the DTO-only arm who did. Surran et al. reported 2 of 32 infants who failed attempts to wean in the concomitant morphine and clonidine group compared with none of the 34 who were in the morphine and phenobarbital group.

In terms of adverse events, one study reported a seizure that was unrelated to treatment (Kraft et al). Agthe et al. reported three infants experiencing seizure in the DTO-only group compared with no infants who received concomitant clonidine. In Surran et al., three infants receiving concomitant phenobarbital and morphine were reported to be oversedated.

In general, the rationale explaining differences in why pharmacologic therapies affect treatment length is underdeveloped, the authors said. Buprenorphine, in particular, is favored because of its ease of dosing schedule and the possible improved safety profile given its longer half-life and greater micro-opioid receptor activity. It has been further suggested that the prolonged half-life of buprenorphine may be responsible for preventing sudden withdrawal symptoms. The researchers found no significant adverse events associated with buprenorphine treatment.

Although there were differences across buprenorphine treatment protocols, Dr. Disher and his colleagues noted that they were “broadly similar.” The authors conceded, however, that there is reason to question “how much of the observed improvement in buprenorphine may be attributable to the differences in optimization of the treatment and weaning protocols.”

Based on findings in this review, the authors caution that it is unlikely “that the current evidence base is sufficient to recommend specific large-scale changes in treatment away from the current standard of care.”

Despite recent research, which proposes trying nonpharmacologic treatments first and incorporating shared rooms for families and infants to reduce length of stay when treatment is required, up to 70% of infants ultimately require pharmacologic treatment. When drug therapy is needed, the average length of stay and overall treatment costs double, 10.9 vs. 22 days and $20,708 vs. $44,720, respectively.

Since results of the analysis show benefit, however variable, in reducing the length of treatment, “continued efforts to identify the optimal pharmacological agents are justified,” urged Dr. Disher and his associates.

Ultimately, before buprenorphine can be considered as a universally accepted standard of care in the treatment of NAS, “a large multisite pragmatic trial that compares buprenorphine with other treatments” will be needed.

One of the researchers – Chris Cameron, PhD – is an employee and holds shares of the Cornerstone Research Group, which provides consultant services to various pharmaceutical and device companies. Dr. Disher is a subcontractor for the Cornerstone Research Group. There were no other disclosures to report.

SOURCE: Disher T et al. JAMA Pediatr. 2019. doi: 10.1001/jamapediatrics.2018.5044.

Gay men who become fathers still commonly experience barriers and stigma, but those living in states that offer legal protections experienced less stigma and fewer barriers, according to Ellen C. Perrin, MD, of Tufts Medical Center in Boston and her associates.

Juanmonino/iStock/Getty Images

A total of 732 fathers living in 47 states, with 1,316 children (average age, 13 years), responded to a survey, they wrote in Pediatrics. More than 80% had a male partner, 64% had earned a bachelor degree or higher, and 81% were white and non-Hispanic.

In 35% of cases, children entered a family through adoption and/or foster care, 14% through the assistance of a pregnancy carrier or surrogate, and 39% through a heterosexual relationship. Families in states with fewer legal protections were more likely to have been formed through heterosexual relationships (odds ratio, 1.42; 95% confidence interval, 1.11-1.81), while families in states with a greater equality rating were more likely to have been formed through a pregnancy surrogate (OR, 1.41; 95% CI, 1.08-1.84). A total of 41% of fathers reported facing barriers to adoption, and 33% reported having difficulty arranging custody of children born in a heterosexual relationship.

Nearly two-thirds of fathers reported having experienced stigma, and just over half had actively avoided a situation for fear of stigma in the past year. Active stigma experienced by the fathers was most commonly experienced in a religious setting, reported by 35%, with other common sources including neighbors (28%), service providers (26%), family members (24%), gay friends (24%), the child’s school (18%), the workplace (16%), and in health care (11%). Children most often experienced active stigma by their friends (33%), followed by a religious setting (17%), school (16%), neighbors (15%), family (11%), and in health care settings (4%).

Active and avoidant stigma was more likely in states with a low equality rating, especially in religious settings and among family members and neighbors, the investigators noted.

“Given their important role as leaders in the community’s support for all families, pediatricians caring for children and their gay fathers should recognize the likelihood that stigma may be a part of the family’s experience and help both families and communities to counteract it. Pediatricians also have the opportunity to be leaders in opposing discrimination in religious and other community institutions,” Dr. Perrin and her associates wrote.

The study received funding from the Gil Foundation, the Arcus Foundation, and private donations. The study authors reported no relevant financial disclosures or conflicts of interest.

lfranki@mdedge.com

SOURCE: Perrin EC et al. Pediatrics. 2019 Jan 14. doi: 10.1542/peds.2018-0683.

Gay men who become fathers still commonly experience barriers and stigma, but those living in states that offer legal protections experienced less stigma and fewer barriers, according to Ellen C. Perrin, MD, of Tufts Medical Center in Boston and her associates.

Juanmonino/iStock/Getty Images

A total of 732 fathers living in 47 states, with 1,316 children (average age, 13 years), responded to a survey, they wrote in Pediatrics. More than 80% had a male partner, 64% had earned a bachelor degree or higher, and 81% were white and non-Hispanic.

In 35% of cases, children entered a family through adoption and/or foster care, 14% through the assistance of a pregnancy carrier or surrogate, and 39% through a heterosexual relationship. Families in states with fewer legal protections were more likely to have been formed through heterosexual relationships (odds ratio, 1.42; 95% confidence interval, 1.11-1.81), while families in states with a greater equality rating were more likely to have been formed through a pregnancy surrogate (OR, 1.41; 95% CI, 1.08-1.84). A total of 41% of fathers reported facing barriers to adoption, and 33% reported having difficulty arranging custody of children born in a heterosexual relationship.

Nearly two-thirds of fathers reported having experienced stigma, and just over half had actively avoided a situation for fear of stigma in the past year. Active stigma experienced by the fathers was most commonly experienced in a religious setting, reported by 35%, with other common sources including neighbors (28%), service providers (26%), family members (24%), gay friends (24%), the child’s school (18%), the workplace (16%), and in health care (11%). Children most often experienced active stigma by their friends (33%), followed by a religious setting (17%), school (16%), neighbors (15%), family (11%), and in health care settings (4%).

Active and avoidant stigma was more likely in states with a low equality rating, especially in religious settings and among family members and neighbors, the investigators noted.

“Given their important role as leaders in the community’s support for all families, pediatricians caring for children and their gay fathers should recognize the likelihood that stigma may be a part of the family’s experience and help both families and communities to counteract it. Pediatricians also have the opportunity to be leaders in opposing discrimination in religious and other community institutions,” Dr. Perrin and her associates wrote.

The study received funding from the Gil Foundation, the Arcus Foundation, and private donations. The study authors reported no relevant financial disclosures or conflicts of interest.

lfranki@mdedge.com

SOURCE: Perrin EC et al. Pediatrics. 2019 Jan 14. doi: 10.1542/peds.2018-0683.

Gay men who become fathers still commonly experience barriers and stigma, but those living in states that offer legal protections experienced less stigma and fewer barriers, according to Ellen C. Perrin, MD, of Tufts Medical Center in Boston and her associates.

Juanmonino/iStock/Getty Images

A total of 732 fathers living in 47 states, with 1,316 children (average age, 13 years), responded to a survey, they wrote in Pediatrics. More than 80% had a male partner, 64% had earned a bachelor degree or higher, and 81% were white and non-Hispanic.

In 35% of cases, children entered a family through adoption and/or foster care, 14% through the assistance of a pregnancy carrier or surrogate, and 39% through a heterosexual relationship. Families in states with fewer legal protections were more likely to have been formed through heterosexual relationships (odds ratio, 1.42; 95% confidence interval, 1.11-1.81), while families in states with a greater equality rating were more likely to have been formed through a pregnancy surrogate (OR, 1.41; 95% CI, 1.08-1.84). A total of 41% of fathers reported facing barriers to adoption, and 33% reported having difficulty arranging custody of children born in a heterosexual relationship.

Nearly two-thirds of fathers reported having experienced stigma, and just over half had actively avoided a situation for fear of stigma in the past year. Active stigma experienced by the fathers was most commonly experienced in a religious setting, reported by 35%, with other common sources including neighbors (28%), service providers (26%), family members (24%), gay friends (24%), the child’s school (18%), the workplace (16%), and in health care (11%). Children most often experienced active stigma by their friends (33%), followed by a religious setting (17%), school (16%), neighbors (15%), family (11%), and in health care settings (4%).

Active and avoidant stigma was more likely in states with a low equality rating, especially in religious settings and among family members and neighbors, the investigators noted.

“Given their important role as leaders in the community’s support for all families, pediatricians caring for children and their gay fathers should recognize the likelihood that stigma may be a part of the family’s experience and help both families and communities to counteract it. Pediatricians also have the opportunity to be leaders in opposing discrimination in religious and other community institutions,” Dr. Perrin and her associates wrote.

The study received funding from the Gil Foundation, the Arcus Foundation, and private donations. The study authors reported no relevant financial disclosures or conflicts of interest.

lfranki@mdedge.com

SOURCE: Perrin EC et al. Pediatrics. 2019 Jan 14. doi: 10.1542/peds.2018-0683.

The Food and Drug Administration has approved the Amplatzer Piccolo Occluder to treat patent ductus arteriosus (PDA) in premature infants weighing as little as 2 pounds.

PDA is a life-threatening opening between two blood vessels leading from the heart and commonly occurs in premature infants, with about one in five infants born prematurely having a hemodynamically significant PDA. The Amplatzer Piccolo Occluder is a self-expanding, wire mesh device that is minimally invasive and is the first device approved for use in very-low-birth-weight infants.

FDA approval was based on results of the ADO II AS trial, which evaluated the device in 50 patients with PDA who were older than 3 days. In addition, the safety and efficacy of the Amplatzer Piccolo Occluder was supported by a continued access protocol involving 150 more patients.

“This approval is a potentially life-saving advance for the very smallest premature infants that will help us treat these delicate babies who might otherwise not be able to survive,” said Evan Zahn, MD, principal investigator of ADO II AS and director of the congenital heart program at Cedars-Sinai’s Smidt Heart Institute in Los Angeles.

Find the full press release on the Abbott website.

lfranki@mdedge.com

The Food and Drug Administration has approved the Amplatzer Piccolo Occluder to treat patent ductus arteriosus (PDA) in premature infants weighing as little as 2 pounds.

PDA is a life-threatening opening between two blood vessels leading from the heart and commonly occurs in premature infants, with about one in five infants born prematurely having a hemodynamically significant PDA. The Amplatzer Piccolo Occluder is a self-expanding, wire mesh device that is minimally invasive and is the first device approved for use in very-low-birth-weight infants.

FDA approval was based on results of the ADO II AS trial, which evaluated the device in 50 patients with PDA who were older than 3 days. In addition, the safety and efficacy of the Amplatzer Piccolo Occluder was supported by a continued access protocol involving 150 more patients.

“This approval is a potentially life-saving advance for the very smallest premature infants that will help us treat these delicate babies who might otherwise not be able to survive,” said Evan Zahn, MD, principal investigator of ADO II AS and director of the congenital heart program at Cedars-Sinai’s Smidt Heart Institute in Los Angeles.

Find the full press release on the Abbott website.

lfranki@mdedge.com

The Food and Drug Administration has approved the Amplatzer Piccolo Occluder to treat patent ductus arteriosus (PDA) in premature infants weighing as little as 2 pounds.

PDA is a life-threatening opening between two blood vessels leading from the heart and commonly occurs in premature infants, with about one in five infants born prematurely having a hemodynamically significant PDA. The Amplatzer Piccolo Occluder is a self-expanding, wire mesh device that is minimally invasive and is the first device approved for use in very-low-birth-weight infants.

FDA approval was based on results of the ADO II AS trial, which evaluated the device in 50 patients with PDA who were older than 3 days. In addition, the safety and efficacy of the Amplatzer Piccolo Occluder was supported by a continued access protocol involving 150 more patients.

“This approval is a potentially life-saving advance for the very smallest premature infants that will help us treat these delicate babies who might otherwise not be able to survive,” said Evan Zahn, MD, principal investigator of ADO II AS and director of the congenital heart program at Cedars-Sinai’s Smidt Heart Institute in Los Angeles.

Find the full press release on the Abbott website.

lfranki@mdedge.com

Gail Erlick Robinson, MD, joins Lorenzo Norris, MD, at the 2018 meeting of the Group for the Advancement of Psychiatry in White Plains, N.Y., to talk about violence against women.Dr. Robinson is professor of psychiatry and obstetrics/gynecology and professor of equality, gender, and population at the University of Toronto. She’s also chair of GAP’s Committee on Gender & Mental Health. In this episode, Dr. Robinson delves into strategies for interacting with survivors of violence, the roots of the “Me Too” movement, as well as rising rates of maternal mortality in the United States.
​​​​​​​Amazon
Apple Podcasts
Google Podcasts
Spotify


 

Gail Erlick Robinson, MD, joins Lorenzo Norris, MD, at the 2018 meeting of the Group for the Advancement of Psychiatry in White Plains, N.Y., to talk about violence against women.Dr. Robinson is professor of psychiatry and obstetrics/gynecology and professor of equality, gender, and population at the University of Toronto. She’s also chair of GAP’s Committee on Gender & Mental Health. In this episode, Dr. Robinson delves into strategies for interacting with survivors of violence, the roots of the “Me Too” movement, as well as rising rates of maternal mortality in the United States.
​​​​​​​Amazon
Apple Podcasts
Google Podcasts
Spotify


 

Gail Erlick Robinson, MD, joins Lorenzo Norris, MD, at the 2018 meeting of the Group for the Advancement of Psychiatry in White Plains, N.Y., to talk about violence against women.Dr. Robinson is professor of psychiatry and obstetrics/gynecology and professor of equality, gender, and population at the University of Toronto. She’s also chair of GAP’s Committee on Gender & Mental Health. In this episode, Dr. Robinson delves into strategies for interacting with survivors of violence, the roots of the “Me Too” movement, as well as rising rates of maternal mortality in the United States.
​​​​​​​Amazon
Apple Podcasts
Google Podcasts
Spotify