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Urge expectant parents to have prenatal pediatrician visit
All parents-to-be, especially first-time parents, should visit a pediatrician during the third trimester of pregnancy to establish a relationship, according to an updated clinical report on the prenatal visit issued by the American Academy of Pediatrics. The report was published online June 25 and in the July issue of Pediatrics.
“It’s a chance to talk about how to keep a baby safe and thriving physically, but also ways to build strong parent-child bonds that promote resilience and help a child stay emotionally healthy,” Michael Yogman, MD, of Harvard Medical School, Boston, said in a statement. Dr. Yogman was the lead author of the report and chair of the AAP Committee on Psychosocial Aspects of Child and Family Health.
A comprehensive prenatal visit gives pediatricians the opportunity to meet four objectives: build a trusting relationship with parents, gather information about family history, provide advice and guidance on infant care and safety, and identify risk factors for psychosocial issues such as perinatal depression, according to the report in Pediatrics.
The prenatal visit allows families and clinicians to learn whether their philosophies align to start a relationship that may last for many years and this visit can include extended family members such as grandparents. In addition, pediatricians can use the prenatal visit as an opportunity to learn more about family history including past pregnancies, failed and successful, as well as pregnancy complications, chronic medical conditions in family members that may affect the home environment, and plans for child care if parents will be working outside the home.
The report also emphasizes “positive parenting” and the role of pediatricians at a prenatal visit in offering support and guidance to help prepare parents for infant care. This guidance may include advice on feeding, sleeping, diapering, and bathing, as well as acknowledging cultural practices.
The authors noted that a prime opporunity to schedule the prenatal visit is when an expectant parent seeking information about insurance, practice hours, and whether the practice is taking new patients.
The AAP advises clinicians to encourage same sex parents, parents expecting via surrogate, and parents who are adopting to schedule a prenatal visit to identify particular concerns they may have.
“This is the only routine child wellness visit recommended by the American Academy of Pediatrics that doesn’t actually require a child in the room,” coauthor Arthur Lavin, MD, also of Harvard Medical School, said in a statement.
The prenatal visit “gives parents an opportunity to really focus on any questions and concerns they may have. They can talk with a pediatrician before the fatigue of new parenthood sets in and there’s an adorably distracting little human in their arms who may be crying, spitting up, or in immediate need of feeding or a diaper change,” Dr. Lavin said.
“At its heart and soul,” Dr. Lavin noted, “this visit is about laying a foundation for a trusting, supportive relationship between the family and their pediatrician, who will work together to keep the child healthy for the next 18 or 20 years.”
The report recommends the Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, Fourth Edition, as a resource for clinicians. The researchers had no financial conflicts to disclose.
SOURCE: Yogman M et al. Pediatrics. 2018; doi: 10.1542/peds. 2018-1218
All parents-to-be, especially first-time parents, should visit a pediatrician during the third trimester of pregnancy to establish a relationship, according to an updated clinical report on the prenatal visit issued by the American Academy of Pediatrics. The report was published online June 25 and in the July issue of Pediatrics.
“It’s a chance to talk about how to keep a baby safe and thriving physically, but also ways to build strong parent-child bonds that promote resilience and help a child stay emotionally healthy,” Michael Yogman, MD, of Harvard Medical School, Boston, said in a statement. Dr. Yogman was the lead author of the report and chair of the AAP Committee on Psychosocial Aspects of Child and Family Health.
A comprehensive prenatal visit gives pediatricians the opportunity to meet four objectives: build a trusting relationship with parents, gather information about family history, provide advice and guidance on infant care and safety, and identify risk factors for psychosocial issues such as perinatal depression, according to the report in Pediatrics.
The prenatal visit allows families and clinicians to learn whether their philosophies align to start a relationship that may last for many years and this visit can include extended family members such as grandparents. In addition, pediatricians can use the prenatal visit as an opportunity to learn more about family history including past pregnancies, failed and successful, as well as pregnancy complications, chronic medical conditions in family members that may affect the home environment, and plans for child care if parents will be working outside the home.
The report also emphasizes “positive parenting” and the role of pediatricians at a prenatal visit in offering support and guidance to help prepare parents for infant care. This guidance may include advice on feeding, sleeping, diapering, and bathing, as well as acknowledging cultural practices.
The authors noted that a prime opporunity to schedule the prenatal visit is when an expectant parent seeking information about insurance, practice hours, and whether the practice is taking new patients.
The AAP advises clinicians to encourage same sex parents, parents expecting via surrogate, and parents who are adopting to schedule a prenatal visit to identify particular concerns they may have.
“This is the only routine child wellness visit recommended by the American Academy of Pediatrics that doesn’t actually require a child in the room,” coauthor Arthur Lavin, MD, also of Harvard Medical School, said in a statement.
The prenatal visit “gives parents an opportunity to really focus on any questions and concerns they may have. They can talk with a pediatrician before the fatigue of new parenthood sets in and there’s an adorably distracting little human in their arms who may be crying, spitting up, or in immediate need of feeding or a diaper change,” Dr. Lavin said.
“At its heart and soul,” Dr. Lavin noted, “this visit is about laying a foundation for a trusting, supportive relationship between the family and their pediatrician, who will work together to keep the child healthy for the next 18 or 20 years.”
The report recommends the Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, Fourth Edition, as a resource for clinicians. The researchers had no financial conflicts to disclose.
SOURCE: Yogman M et al. Pediatrics. 2018; doi: 10.1542/peds. 2018-1218
All parents-to-be, especially first-time parents, should visit a pediatrician during the third trimester of pregnancy to establish a relationship, according to an updated clinical report on the prenatal visit issued by the American Academy of Pediatrics. The report was published online June 25 and in the July issue of Pediatrics.
“It’s a chance to talk about how to keep a baby safe and thriving physically, but also ways to build strong parent-child bonds that promote resilience and help a child stay emotionally healthy,” Michael Yogman, MD, of Harvard Medical School, Boston, said in a statement. Dr. Yogman was the lead author of the report and chair of the AAP Committee on Psychosocial Aspects of Child and Family Health.
A comprehensive prenatal visit gives pediatricians the opportunity to meet four objectives: build a trusting relationship with parents, gather information about family history, provide advice and guidance on infant care and safety, and identify risk factors for psychosocial issues such as perinatal depression, according to the report in Pediatrics.
The prenatal visit allows families and clinicians to learn whether their philosophies align to start a relationship that may last for many years and this visit can include extended family members such as grandparents. In addition, pediatricians can use the prenatal visit as an opportunity to learn more about family history including past pregnancies, failed and successful, as well as pregnancy complications, chronic medical conditions in family members that may affect the home environment, and plans for child care if parents will be working outside the home.
The report also emphasizes “positive parenting” and the role of pediatricians at a prenatal visit in offering support and guidance to help prepare parents for infant care. This guidance may include advice on feeding, sleeping, diapering, and bathing, as well as acknowledging cultural practices.
The authors noted that a prime opporunity to schedule the prenatal visit is when an expectant parent seeking information about insurance, practice hours, and whether the practice is taking new patients.
The AAP advises clinicians to encourage same sex parents, parents expecting via surrogate, and parents who are adopting to schedule a prenatal visit to identify particular concerns they may have.
“This is the only routine child wellness visit recommended by the American Academy of Pediatrics that doesn’t actually require a child in the room,” coauthor Arthur Lavin, MD, also of Harvard Medical School, said in a statement.
The prenatal visit “gives parents an opportunity to really focus on any questions and concerns they may have. They can talk with a pediatrician before the fatigue of new parenthood sets in and there’s an adorably distracting little human in their arms who may be crying, spitting up, or in immediate need of feeding or a diaper change,” Dr. Lavin said.
“At its heart and soul,” Dr. Lavin noted, “this visit is about laying a foundation for a trusting, supportive relationship between the family and their pediatrician, who will work together to keep the child healthy for the next 18 or 20 years.”
The report recommends the Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, Fourth Edition, as a resource for clinicians. The researchers had no financial conflicts to disclose.
SOURCE: Yogman M et al. Pediatrics. 2018; doi: 10.1542/peds. 2018-1218
FROM PEDIATRICS
Buprenorphine endangers lives and health of children
Eleven children died from exposure to buprenorphine – a drug used to treat opioid exposure – from 2007 to 2016, mostly very young children who accidentally ingested the drug.
Four deaths, however, were teens who took buprenorphine recreationally or used it in a suicide attempt, according to a new database review by Sara Post, MS, of the Research Institute at Nationwide Children’s Hospital, Columbus, Ohio, and her associates.
“In 2016, the American Academy of Pediatrics issued a statement advocating for increased access to buprenorphine for opioid-addicted adolescents in primary care settings,” the authors noted. “This recommendation is warranted because of the high and increasing prevalence of opioid dependence among adolescents. However, caution should be used, because increased prescriptions among adolescents could lead to increased diversion and abuse and increased access to younger children in the home. Therefore, patient education for adolescents should include information about the dangers of misusing and/or abusing prescription drugs and the proper storage of medications.”
The deaths comprise a small fraction of the 11,275 children aged 19 years and younger whose buprenorphine ingestions were reported to a poison control center during that time, the investigators said. Nevertheless, almost half (45%) of the exposed children were admitted to a health care facility – with 22% needing treatment in a critical care unit.
The rate of exposures was highest during the years when only tablet formulations were available and fell after film was introduced, wrote Ms. Post, a medical student at the Northeast Ohio Medical University in Rootstown, and her colleagues. But after 2013, the rate held steady, at about 38 exposures per 1 million children per year.
Childproof packaging for all buprenorphine formulations could help protect younger children, and education could help protect older ones, she and her coinvestigators said. Manufacturers should use unit-dose packaging for all buprenorphine products to help prevent unintentional exposure among young children. Health care providers should inform caregivers of young children about the dangers of buprenorphine exposure and provide instructions on proper storage and disposal of medications. Adolescents should receive information regarding the risks of substance abuse and misuse.”
Ms. Post and her colleagues analyzed calls to poison control centers affiliated with the National Poison Data System from 2007 to 2016. During that time, the centers received 11,275 calls about buprenorphine exposure among children and adolescents 19 years and younger.
The mean age of exposure in children was about 4 years; children younger than 6 years comprised 86% of the exposures (9,709).
The investigators noted temporal trends in exposure rates in this group. From 2007 to 2013, the rate increased by 215%, peaking at 20 per 1 million in 2010. A decline followed, with exposure dropping to 12 per 1 million in 2013, before rising again to 13 in 2016.
The increase “was likely attributable to the increasing number of buprenorphine prescriptions dispensed since the Food and Drug Administration approved its use as a treatment of opioid dependence in 2002,” Ms. Post and her colleagues wrote.
The transient decrease may have been related to a shift in adult prescribing patterns, as the drug was prescribed less often to those in their 20s and gradually given more often to people aged 40-59 years.
The decrease also was probably related to the packaging shift from tablet to film. “In 2013, the leading brand-name tablets were voluntarily withdrawn from the U.S. market because of potential risk of unintentional pediatric exposures,” the team wrote. Unfortunately, the film packaging didn’t completely deter some children; from 2013 to 2016, there was a 30% increase in the frequency of exposures to buprenorphine film.
The bulk of exposures were unintentional (98%) and involved ingestion of a single buprenorphine product. However, the authors noted, even a single adult therapeutic dose can be extremely dangerous to a small child.
“Therapeutic doses of buprenorphine-naloxone for pediatric patients are 2 to 6 mcg/kg, so ingestion of a single 2-mg sublingual tablet in a 10-kg child can result in more than a 30-fold overdose. This is particularly dangerous, because children exposed to buprenorphine do not display the ‘ceiling effect’ reported in adults, in which escalating doses do not lead to additional increases in respiratory depression,” Ms. Post and her coauthors said.
This was reflected in the serious clinical effects experienced: respiratory depression, bradycardia, coma, cyanosis, respiratory arrest, seizure, and cardiac arrest. These youngest children experienced the most serious outcomes, with half requiring a hospital admittance and 21% experiencing a serious medical outcome. Seven died, six of whom were 2 years or younger.
There were 315 (3%) exposures in children aged 6-12 years; most of these (83%) were either unintentional or therapeutic errors (18%). About 30% of the group required hospital admission and about 12% experienced a serious medical outcome. There were no fatalities among this group, the investigators noted.
Among adolescents aged 13-19 years, there were 1,251 (11%) exposures and four deaths. The bulk of these (77%) was intentional, with suspected suicide accounting for 12%, and 30% involving more than one substance. The exposure rate followed the same general trends, rising to a peak of about 6 per 1 million in 2010 and the falling and leveling off at about 3 per 1 million in 2016, they said.
About 22% of teen exposures required hospital admission, with 11% needing treatment in a critical care unit. The four deaths, one of which was a suicide, all involved multiple substances (benzodiazepines, alcohol, and marijuana).
Ms. Post received a research stipend from the National Student Injury Research Training Program while she worked on the study. The coauthors had no relevant financial disclosures.
SOURCE: Post et al. Pediatrics. 2018;142:e20173652.
Eleven children died from exposure to buprenorphine – a drug used to treat opioid exposure – from 2007 to 2016, mostly very young children who accidentally ingested the drug.
Four deaths, however, were teens who took buprenorphine recreationally or used it in a suicide attempt, according to a new database review by Sara Post, MS, of the Research Institute at Nationwide Children’s Hospital, Columbus, Ohio, and her associates.
“In 2016, the American Academy of Pediatrics issued a statement advocating for increased access to buprenorphine for opioid-addicted adolescents in primary care settings,” the authors noted. “This recommendation is warranted because of the high and increasing prevalence of opioid dependence among adolescents. However, caution should be used, because increased prescriptions among adolescents could lead to increased diversion and abuse and increased access to younger children in the home. Therefore, patient education for adolescents should include information about the dangers of misusing and/or abusing prescription drugs and the proper storage of medications.”
The deaths comprise a small fraction of the 11,275 children aged 19 years and younger whose buprenorphine ingestions were reported to a poison control center during that time, the investigators said. Nevertheless, almost half (45%) of the exposed children were admitted to a health care facility – with 22% needing treatment in a critical care unit.
The rate of exposures was highest during the years when only tablet formulations were available and fell after film was introduced, wrote Ms. Post, a medical student at the Northeast Ohio Medical University in Rootstown, and her colleagues. But after 2013, the rate held steady, at about 38 exposures per 1 million children per year.
Childproof packaging for all buprenorphine formulations could help protect younger children, and education could help protect older ones, she and her coinvestigators said. Manufacturers should use unit-dose packaging for all buprenorphine products to help prevent unintentional exposure among young children. Health care providers should inform caregivers of young children about the dangers of buprenorphine exposure and provide instructions on proper storage and disposal of medications. Adolescents should receive information regarding the risks of substance abuse and misuse.”
Ms. Post and her colleagues analyzed calls to poison control centers affiliated with the National Poison Data System from 2007 to 2016. During that time, the centers received 11,275 calls about buprenorphine exposure among children and adolescents 19 years and younger.
The mean age of exposure in children was about 4 years; children younger than 6 years comprised 86% of the exposures (9,709).
The investigators noted temporal trends in exposure rates in this group. From 2007 to 2013, the rate increased by 215%, peaking at 20 per 1 million in 2010. A decline followed, with exposure dropping to 12 per 1 million in 2013, before rising again to 13 in 2016.
The increase “was likely attributable to the increasing number of buprenorphine prescriptions dispensed since the Food and Drug Administration approved its use as a treatment of opioid dependence in 2002,” Ms. Post and her colleagues wrote.
The transient decrease may have been related to a shift in adult prescribing patterns, as the drug was prescribed less often to those in their 20s and gradually given more often to people aged 40-59 years.
The decrease also was probably related to the packaging shift from tablet to film. “In 2013, the leading brand-name tablets were voluntarily withdrawn from the U.S. market because of potential risk of unintentional pediatric exposures,” the team wrote. Unfortunately, the film packaging didn’t completely deter some children; from 2013 to 2016, there was a 30% increase in the frequency of exposures to buprenorphine film.
The bulk of exposures were unintentional (98%) and involved ingestion of a single buprenorphine product. However, the authors noted, even a single adult therapeutic dose can be extremely dangerous to a small child.
“Therapeutic doses of buprenorphine-naloxone for pediatric patients are 2 to 6 mcg/kg, so ingestion of a single 2-mg sublingual tablet in a 10-kg child can result in more than a 30-fold overdose. This is particularly dangerous, because children exposed to buprenorphine do not display the ‘ceiling effect’ reported in adults, in which escalating doses do not lead to additional increases in respiratory depression,” Ms. Post and her coauthors said.
This was reflected in the serious clinical effects experienced: respiratory depression, bradycardia, coma, cyanosis, respiratory arrest, seizure, and cardiac arrest. These youngest children experienced the most serious outcomes, with half requiring a hospital admittance and 21% experiencing a serious medical outcome. Seven died, six of whom were 2 years or younger.
There were 315 (3%) exposures in children aged 6-12 years; most of these (83%) were either unintentional or therapeutic errors (18%). About 30% of the group required hospital admission and about 12% experienced a serious medical outcome. There were no fatalities among this group, the investigators noted.
Among adolescents aged 13-19 years, there were 1,251 (11%) exposures and four deaths. The bulk of these (77%) was intentional, with suspected suicide accounting for 12%, and 30% involving more than one substance. The exposure rate followed the same general trends, rising to a peak of about 6 per 1 million in 2010 and the falling and leveling off at about 3 per 1 million in 2016, they said.
About 22% of teen exposures required hospital admission, with 11% needing treatment in a critical care unit. The four deaths, one of which was a suicide, all involved multiple substances (benzodiazepines, alcohol, and marijuana).
Ms. Post received a research stipend from the National Student Injury Research Training Program while she worked on the study. The coauthors had no relevant financial disclosures.
SOURCE: Post et al. Pediatrics. 2018;142:e20173652.
Eleven children died from exposure to buprenorphine – a drug used to treat opioid exposure – from 2007 to 2016, mostly very young children who accidentally ingested the drug.
Four deaths, however, were teens who took buprenorphine recreationally or used it in a suicide attempt, according to a new database review by Sara Post, MS, of the Research Institute at Nationwide Children’s Hospital, Columbus, Ohio, and her associates.
“In 2016, the American Academy of Pediatrics issued a statement advocating for increased access to buprenorphine for opioid-addicted adolescents in primary care settings,” the authors noted. “This recommendation is warranted because of the high and increasing prevalence of opioid dependence among adolescents. However, caution should be used, because increased prescriptions among adolescents could lead to increased diversion and abuse and increased access to younger children in the home. Therefore, patient education for adolescents should include information about the dangers of misusing and/or abusing prescription drugs and the proper storage of medications.”
The deaths comprise a small fraction of the 11,275 children aged 19 years and younger whose buprenorphine ingestions were reported to a poison control center during that time, the investigators said. Nevertheless, almost half (45%) of the exposed children were admitted to a health care facility – with 22% needing treatment in a critical care unit.
The rate of exposures was highest during the years when only tablet formulations were available and fell after film was introduced, wrote Ms. Post, a medical student at the Northeast Ohio Medical University in Rootstown, and her colleagues. But after 2013, the rate held steady, at about 38 exposures per 1 million children per year.
Childproof packaging for all buprenorphine formulations could help protect younger children, and education could help protect older ones, she and her coinvestigators said. Manufacturers should use unit-dose packaging for all buprenorphine products to help prevent unintentional exposure among young children. Health care providers should inform caregivers of young children about the dangers of buprenorphine exposure and provide instructions on proper storage and disposal of medications. Adolescents should receive information regarding the risks of substance abuse and misuse.”
Ms. Post and her colleagues analyzed calls to poison control centers affiliated with the National Poison Data System from 2007 to 2016. During that time, the centers received 11,275 calls about buprenorphine exposure among children and adolescents 19 years and younger.
The mean age of exposure in children was about 4 years; children younger than 6 years comprised 86% of the exposures (9,709).
The investigators noted temporal trends in exposure rates in this group. From 2007 to 2013, the rate increased by 215%, peaking at 20 per 1 million in 2010. A decline followed, with exposure dropping to 12 per 1 million in 2013, before rising again to 13 in 2016.
The increase “was likely attributable to the increasing number of buprenorphine prescriptions dispensed since the Food and Drug Administration approved its use as a treatment of opioid dependence in 2002,” Ms. Post and her colleagues wrote.
The transient decrease may have been related to a shift in adult prescribing patterns, as the drug was prescribed less often to those in their 20s and gradually given more often to people aged 40-59 years.
The decrease also was probably related to the packaging shift from tablet to film. “In 2013, the leading brand-name tablets were voluntarily withdrawn from the U.S. market because of potential risk of unintentional pediatric exposures,” the team wrote. Unfortunately, the film packaging didn’t completely deter some children; from 2013 to 2016, there was a 30% increase in the frequency of exposures to buprenorphine film.
The bulk of exposures were unintentional (98%) and involved ingestion of a single buprenorphine product. However, the authors noted, even a single adult therapeutic dose can be extremely dangerous to a small child.
“Therapeutic doses of buprenorphine-naloxone for pediatric patients are 2 to 6 mcg/kg, so ingestion of a single 2-mg sublingual tablet in a 10-kg child can result in more than a 30-fold overdose. This is particularly dangerous, because children exposed to buprenorphine do not display the ‘ceiling effect’ reported in adults, in which escalating doses do not lead to additional increases in respiratory depression,” Ms. Post and her coauthors said.
This was reflected in the serious clinical effects experienced: respiratory depression, bradycardia, coma, cyanosis, respiratory arrest, seizure, and cardiac arrest. These youngest children experienced the most serious outcomes, with half requiring a hospital admittance and 21% experiencing a serious medical outcome. Seven died, six of whom were 2 years or younger.
There were 315 (3%) exposures in children aged 6-12 years; most of these (83%) were either unintentional or therapeutic errors (18%). About 30% of the group required hospital admission and about 12% experienced a serious medical outcome. There were no fatalities among this group, the investigators noted.
Among adolescents aged 13-19 years, there were 1,251 (11%) exposures and four deaths. The bulk of these (77%) was intentional, with suspected suicide accounting for 12%, and 30% involving more than one substance. The exposure rate followed the same general trends, rising to a peak of about 6 per 1 million in 2010 and the falling and leveling off at about 3 per 1 million in 2016, they said.
About 22% of teen exposures required hospital admission, with 11% needing treatment in a critical care unit. The four deaths, one of which was a suicide, all involved multiple substances (benzodiazepines, alcohol, and marijuana).
Ms. Post received a research stipend from the National Student Injury Research Training Program while she worked on the study. The coauthors had no relevant financial disclosures.
SOURCE: Post et al. Pediatrics. 2018;142:e20173652.
FROM PEDIATRICS
Key clinical point: Buprenorphine ingestion remains a threat to children, especially those younger than 6 years.
Major finding: From 2007 to 2016, 11,275 exposures were reported; 11 children died.
Study details: The database review looked at records from the National Poison Data System.
Disclosures: Ms. Post received a research stipend from the National Student Injury Research Training Program while she worked on the study. The coauthors had no relevant financial disclosures.
Source: Post et al. Pediatrics. 2018;142:e20173652.
Norovirus vaccine appears promising in children
MALMO, SWEDEN – in an interim analysis of an ongoing phase 2 study, Taisei Masuda, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
The randomized, double-blind, multinational trial remains blinded because follow-up is continuing, so – to the disappointment of the ESPID audience – there are as yet no data on duration of antibody persistence or clinical efficacy.
However, an earlier phase 2 study in 420 healthy participants aged 18-64 years showed that the Takeda vaccine elicited persistent immune responses 1 year post vaccination and that higher antibody levels correlated with a reduced frequency of moderate to severe vomiting and diarrheal illness following oral challenge with norovirus (Clin Vaccine Immunol. 2015 Aug;22[8]:923-9). Follow-up will continue in order to learn how long the protective immune response lasts in adults, according to Dr. Masuda, of Takeda Pharmaceuticals in Zurich.
The bivalent Takeda vaccine is the first candidate vaccine to reach the randomized trial stage. An oral vaccine in tablet form under development by Vaxart, a San Francisco Bay Area biotech company, recently completed preliminary phase 1 studies.
Dr. Masuda explained that the Takeda vaccine contains virus-like particle antigens from norovirus strains GI.1 and GII.4c, which together account for the majority of human norovirus illness. These virus-like particles are formed on the outer surface of the virus. Of note, virus-like particle–based vaccines against hepatitis B and human papillomavirus have won regulatory approval in the United States, Europe, and elsewhere.
He presented data on 120 healthy subjects aged 1 year to less than 4 years old and another 120 aged 4 years to less than 9 years. They are part of a larger phase 2 study of 840 children as young as age 6 weeks. This was a dose-finding study, so participants received various doses of the vaccine on day 1 and either a second dose or a saline injection 28 days later. The vaccine, which contains aluminum hydroxide to enhance immunogenicity, comes in prefilled syringes.
At 57 days of follow-up in this interim analysis, protective seroresponse rates as defined by at least a fourfold increase in histo-blood group antigen–blocking titers approached 100%. In the older group, this was typically achieved with a single dose of vaccine. However, the younger group of children generally derived further benefit from a second dose, according to Dr. Masuda.
In terms of safety concerns, he said no serious adverse events occurred in the study and no one withdrew from the trial because of vaccine-related side effects. The overall safety picture was the same in the two age groups. The incidence of fever of 38° C or higher was similar after administration of vaccine and placebo. Injection site pain occurred in one-quarter of younger vaccine recipients, in 38%-63% of those aged 4 years or older, and in 17%-22% who got placebo injections. Those and other local and systemic adverse events were mostly mild and transient. Their incidence and severity weren’t related to vaccine dosage.
In sum, Dr. Masuda deemed the safety profile “clinically acceptable.”
Session chair Karina Butler, MD, of Temple Street Children’s University Hospital, Dublin, raised the question of how might this vaccine, which may require two doses in younger children, fit into an already crowded pediatric immunization schedule – will parents and physicians embrace it?
Dr. Masuda replied that noroviruses are the No. 1 cause of acute gastroenteritis worldwide and there is a clamor for development of effective vaccines to protect the groups that bear the greatest burden of disease, including children, the elderly, military personnel, cruise ship vacationers, and others who experience crowded conditions. He expressed confidence that a safe and effective vaccine will be in high demand.
“In the future, we’ll look at the possibility of a combination vaccine,” he added.
In response to audience questions, Dr. Masuda said that in adult studies higher levels of immunogenicity have been achieved after vaccination, compared with natural infection; however, there are as yet no pediatric data on that score. Also, investigators have seen evidence of cross-reactivity to the vaccine in some but not all naturally circulating nonvaccine strains.
The vaccine formulation being carried forward into advanced clinical trials in adults is 15 mcg of GI.1/50 mcg of GII.4c (J Infect Dis. 2018 Jan 30;217[4]:597-607).
The phase 2 study presented by Dr. Masuda was supported by the U.S. Army.
MALMO, SWEDEN – in an interim analysis of an ongoing phase 2 study, Taisei Masuda, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
The randomized, double-blind, multinational trial remains blinded because follow-up is continuing, so – to the disappointment of the ESPID audience – there are as yet no data on duration of antibody persistence or clinical efficacy.
However, an earlier phase 2 study in 420 healthy participants aged 18-64 years showed that the Takeda vaccine elicited persistent immune responses 1 year post vaccination and that higher antibody levels correlated with a reduced frequency of moderate to severe vomiting and diarrheal illness following oral challenge with norovirus (Clin Vaccine Immunol. 2015 Aug;22[8]:923-9). Follow-up will continue in order to learn how long the protective immune response lasts in adults, according to Dr. Masuda, of Takeda Pharmaceuticals in Zurich.
The bivalent Takeda vaccine is the first candidate vaccine to reach the randomized trial stage. An oral vaccine in tablet form under development by Vaxart, a San Francisco Bay Area biotech company, recently completed preliminary phase 1 studies.
Dr. Masuda explained that the Takeda vaccine contains virus-like particle antigens from norovirus strains GI.1 and GII.4c, which together account for the majority of human norovirus illness. These virus-like particles are formed on the outer surface of the virus. Of note, virus-like particle–based vaccines against hepatitis B and human papillomavirus have won regulatory approval in the United States, Europe, and elsewhere.
He presented data on 120 healthy subjects aged 1 year to less than 4 years old and another 120 aged 4 years to less than 9 years. They are part of a larger phase 2 study of 840 children as young as age 6 weeks. This was a dose-finding study, so participants received various doses of the vaccine on day 1 and either a second dose or a saline injection 28 days later. The vaccine, which contains aluminum hydroxide to enhance immunogenicity, comes in prefilled syringes.
At 57 days of follow-up in this interim analysis, protective seroresponse rates as defined by at least a fourfold increase in histo-blood group antigen–blocking titers approached 100%. In the older group, this was typically achieved with a single dose of vaccine. However, the younger group of children generally derived further benefit from a second dose, according to Dr. Masuda.
In terms of safety concerns, he said no serious adverse events occurred in the study and no one withdrew from the trial because of vaccine-related side effects. The overall safety picture was the same in the two age groups. The incidence of fever of 38° C or higher was similar after administration of vaccine and placebo. Injection site pain occurred in one-quarter of younger vaccine recipients, in 38%-63% of those aged 4 years or older, and in 17%-22% who got placebo injections. Those and other local and systemic adverse events were mostly mild and transient. Their incidence and severity weren’t related to vaccine dosage.
In sum, Dr. Masuda deemed the safety profile “clinically acceptable.”
Session chair Karina Butler, MD, of Temple Street Children’s University Hospital, Dublin, raised the question of how might this vaccine, which may require two doses in younger children, fit into an already crowded pediatric immunization schedule – will parents and physicians embrace it?
Dr. Masuda replied that noroviruses are the No. 1 cause of acute gastroenteritis worldwide and there is a clamor for development of effective vaccines to protect the groups that bear the greatest burden of disease, including children, the elderly, military personnel, cruise ship vacationers, and others who experience crowded conditions. He expressed confidence that a safe and effective vaccine will be in high demand.
“In the future, we’ll look at the possibility of a combination vaccine,” he added.
In response to audience questions, Dr. Masuda said that in adult studies higher levels of immunogenicity have been achieved after vaccination, compared with natural infection; however, there are as yet no pediatric data on that score. Also, investigators have seen evidence of cross-reactivity to the vaccine in some but not all naturally circulating nonvaccine strains.
The vaccine formulation being carried forward into advanced clinical trials in adults is 15 mcg of GI.1/50 mcg of GII.4c (J Infect Dis. 2018 Jan 30;217[4]:597-607).
The phase 2 study presented by Dr. Masuda was supported by the U.S. Army.
MALMO, SWEDEN – in an interim analysis of an ongoing phase 2 study, Taisei Masuda, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
The randomized, double-blind, multinational trial remains blinded because follow-up is continuing, so – to the disappointment of the ESPID audience – there are as yet no data on duration of antibody persistence or clinical efficacy.
However, an earlier phase 2 study in 420 healthy participants aged 18-64 years showed that the Takeda vaccine elicited persistent immune responses 1 year post vaccination and that higher antibody levels correlated with a reduced frequency of moderate to severe vomiting and diarrheal illness following oral challenge with norovirus (Clin Vaccine Immunol. 2015 Aug;22[8]:923-9). Follow-up will continue in order to learn how long the protective immune response lasts in adults, according to Dr. Masuda, of Takeda Pharmaceuticals in Zurich.
The bivalent Takeda vaccine is the first candidate vaccine to reach the randomized trial stage. An oral vaccine in tablet form under development by Vaxart, a San Francisco Bay Area biotech company, recently completed preliminary phase 1 studies.
Dr. Masuda explained that the Takeda vaccine contains virus-like particle antigens from norovirus strains GI.1 and GII.4c, which together account for the majority of human norovirus illness. These virus-like particles are formed on the outer surface of the virus. Of note, virus-like particle–based vaccines against hepatitis B and human papillomavirus have won regulatory approval in the United States, Europe, and elsewhere.
He presented data on 120 healthy subjects aged 1 year to less than 4 years old and another 120 aged 4 years to less than 9 years. They are part of a larger phase 2 study of 840 children as young as age 6 weeks. This was a dose-finding study, so participants received various doses of the vaccine on day 1 and either a second dose or a saline injection 28 days later. The vaccine, which contains aluminum hydroxide to enhance immunogenicity, comes in prefilled syringes.
At 57 days of follow-up in this interim analysis, protective seroresponse rates as defined by at least a fourfold increase in histo-blood group antigen–blocking titers approached 100%. In the older group, this was typically achieved with a single dose of vaccine. However, the younger group of children generally derived further benefit from a second dose, according to Dr. Masuda.
In terms of safety concerns, he said no serious adverse events occurred in the study and no one withdrew from the trial because of vaccine-related side effects. The overall safety picture was the same in the two age groups. The incidence of fever of 38° C or higher was similar after administration of vaccine and placebo. Injection site pain occurred in one-quarter of younger vaccine recipients, in 38%-63% of those aged 4 years or older, and in 17%-22% who got placebo injections. Those and other local and systemic adverse events were mostly mild and transient. Their incidence and severity weren’t related to vaccine dosage.
In sum, Dr. Masuda deemed the safety profile “clinically acceptable.”
Session chair Karina Butler, MD, of Temple Street Children’s University Hospital, Dublin, raised the question of how might this vaccine, which may require two doses in younger children, fit into an already crowded pediatric immunization schedule – will parents and physicians embrace it?
Dr. Masuda replied that noroviruses are the No. 1 cause of acute gastroenteritis worldwide and there is a clamor for development of effective vaccines to protect the groups that bear the greatest burden of disease, including children, the elderly, military personnel, cruise ship vacationers, and others who experience crowded conditions. He expressed confidence that a safe and effective vaccine will be in high demand.
“In the future, we’ll look at the possibility of a combination vaccine,” he added.
In response to audience questions, Dr. Masuda said that in adult studies higher levels of immunogenicity have been achieved after vaccination, compared with natural infection; however, there are as yet no pediatric data on that score. Also, investigators have seen evidence of cross-reactivity to the vaccine in some but not all naturally circulating nonvaccine strains.
The vaccine formulation being carried forward into advanced clinical trials in adults is 15 mcg of GI.1/50 mcg of GII.4c (J Infect Dis. 2018 Jan 30;217[4]:597-607).
The phase 2 study presented by Dr. Masuda was supported by the U.S. Army.
REPORTING FROM ESPID 2018
Key clinical point: Hope runs high that an effective norovirus vaccine is in the works.
Major finding: Protective seroresponse rates against the two chief disease-causing strains of norovirus were seen in nearly 100% of vaccinated children aged 1-8 years.
Study details: This is an ongoing prospective, multicenter, double-blind, phase 2 randomized trial including 840 children.
Disclosures: The study was supported by the U.S. Army and presented by an employee of Takeda Pharmaceuticals.
U.S. immigration policy: What harms will persist?
The Trump policy of separating children and teenagers from their parents after crossing the U.S. border has been called un-American, immoral, cruel, and inhumane. The policy thankfully has been reversed or at least subject to delay. However, as I write today, 2,300 children and their parents are separated, not in contact, lost to each other, and with no clear plan on reunification. The ultimate outcome of immigration legislation and policy is unknown and mired in partisan politics. The policy hopefully has changed permanently, but what are the harms that will persist?
1. Many if not all of the 2,300 children taken from their parents to institutional settings will have suffered acute anxiety and despair. Following data gathered by René Spitz and John Bowlby 80 years ago, children forced to separate from their parents for long hospitalizations with limited visitation went through phases of protest, despair, and if repeated or lengthy separations, “detachment” that impaired their ability to form relationships.1
2. Many of these children have suffered traumas in their country of origin and through the journey to the U.S. border. Some of this traumatic experience was mitigated by being in the presence of their parent(s). Very likely some children have psychiatric and physical disorders that will add to the level of risk. The current trauma, forcible separation by armed guards into restrictive facilities, will compound or intensify the previous traumas without the benefit of parental support.
3. Will the harms persist? Likely this level of trauma has such a strong neurologic and psychological impact that many of the children will suffer from nightmares, depression, and persistent anxiety about trusting the safety of their setting. 2
4. The parents who are jailed, have had their children removed, and do not know where they are and aren’t able to talk to them have suffered a massive trauma. We all have lost sight of a child for a minute or two in a store or on the beach. Our anxiety is immediate, and if the separation is longer, we may remember those frightening minutes for the rest of our lives. How many immigrant parents will develop depression and posttraumatic stress disorder?
5. Guards were ordered to be the front-line implementers of the policy and must have been torn between their sworn duty and their inner knowledge that what they are doing is wrong. Hearing the children crying and calling for their parents must have elicited painful feelings of what it would have been like to have their own children taken away with no way to reach them or knowing where they were taken. Implementing this policy dehumanized them, and I believe made them feel guilty or unworthy.
6. Millions of immigrants – whether lawful, dreamers, or undocumented – must have felt fearful, powerless, and angry about this policy. Millions of their children must have been worried and lost a little bit of faith in their parents and in the United States.
7. Did U.S. citizens, many from immigrant roots, wonder if this could happen to them? How many children felt a little less secure? Was the anxiety higher for descendants of the U.S. citizens remembering the trauma of the World War II Japanese internment camps? Other descendants (like me) will remember quite vividly their mother’s story of being on the St. Louis steam ship and being turned away from the United States to face a high likelihood of death in Nazi Germany. A bit of fear will replace trust in and loyalty to the United States.
Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email him at pdnews@mdedge.com.
References:
1. Dev Psychol. 1992;28:759-75.
2. www.cdc.gov/violenceprevention/acestudy/index.html
The Trump policy of separating children and teenagers from their parents after crossing the U.S. border has been called un-American, immoral, cruel, and inhumane. The policy thankfully has been reversed or at least subject to delay. However, as I write today, 2,300 children and their parents are separated, not in contact, lost to each other, and with no clear plan on reunification. The ultimate outcome of immigration legislation and policy is unknown and mired in partisan politics. The policy hopefully has changed permanently, but what are the harms that will persist?
1. Many if not all of the 2,300 children taken from their parents to institutional settings will have suffered acute anxiety and despair. Following data gathered by René Spitz and John Bowlby 80 years ago, children forced to separate from their parents for long hospitalizations with limited visitation went through phases of protest, despair, and if repeated or lengthy separations, “detachment” that impaired their ability to form relationships.1
2. Many of these children have suffered traumas in their country of origin and through the journey to the U.S. border. Some of this traumatic experience was mitigated by being in the presence of their parent(s). Very likely some children have psychiatric and physical disorders that will add to the level of risk. The current trauma, forcible separation by armed guards into restrictive facilities, will compound or intensify the previous traumas without the benefit of parental support.
3. Will the harms persist? Likely this level of trauma has such a strong neurologic and psychological impact that many of the children will suffer from nightmares, depression, and persistent anxiety about trusting the safety of their setting. 2
4. The parents who are jailed, have had their children removed, and do not know where they are and aren’t able to talk to them have suffered a massive trauma. We all have lost sight of a child for a minute or two in a store or on the beach. Our anxiety is immediate, and if the separation is longer, we may remember those frightening minutes for the rest of our lives. How many immigrant parents will develop depression and posttraumatic stress disorder?
5. Guards were ordered to be the front-line implementers of the policy and must have been torn between their sworn duty and their inner knowledge that what they are doing is wrong. Hearing the children crying and calling for their parents must have elicited painful feelings of what it would have been like to have their own children taken away with no way to reach them or knowing where they were taken. Implementing this policy dehumanized them, and I believe made them feel guilty or unworthy.
6. Millions of immigrants – whether lawful, dreamers, or undocumented – must have felt fearful, powerless, and angry about this policy. Millions of their children must have been worried and lost a little bit of faith in their parents and in the United States.
7. Did U.S. citizens, many from immigrant roots, wonder if this could happen to them? How many children felt a little less secure? Was the anxiety higher for descendants of the U.S. citizens remembering the trauma of the World War II Japanese internment camps? Other descendants (like me) will remember quite vividly their mother’s story of being on the St. Louis steam ship and being turned away from the United States to face a high likelihood of death in Nazi Germany. A bit of fear will replace trust in and loyalty to the United States.
Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email him at pdnews@mdedge.com.
References:
1. Dev Psychol. 1992;28:759-75.
2. www.cdc.gov/violenceprevention/acestudy/index.html
The Trump policy of separating children and teenagers from their parents after crossing the U.S. border has been called un-American, immoral, cruel, and inhumane. The policy thankfully has been reversed or at least subject to delay. However, as I write today, 2,300 children and their parents are separated, not in contact, lost to each other, and with no clear plan on reunification. The ultimate outcome of immigration legislation and policy is unknown and mired in partisan politics. The policy hopefully has changed permanently, but what are the harms that will persist?
1. Many if not all of the 2,300 children taken from their parents to institutional settings will have suffered acute anxiety and despair. Following data gathered by René Spitz and John Bowlby 80 years ago, children forced to separate from their parents for long hospitalizations with limited visitation went through phases of protest, despair, and if repeated or lengthy separations, “detachment” that impaired their ability to form relationships.1
2. Many of these children have suffered traumas in their country of origin and through the journey to the U.S. border. Some of this traumatic experience was mitigated by being in the presence of their parent(s). Very likely some children have psychiatric and physical disorders that will add to the level of risk. The current trauma, forcible separation by armed guards into restrictive facilities, will compound or intensify the previous traumas without the benefit of parental support.
3. Will the harms persist? Likely this level of trauma has such a strong neurologic and psychological impact that many of the children will suffer from nightmares, depression, and persistent anxiety about trusting the safety of their setting. 2
4. The parents who are jailed, have had their children removed, and do not know where they are and aren’t able to talk to them have suffered a massive trauma. We all have lost sight of a child for a minute or two in a store or on the beach. Our anxiety is immediate, and if the separation is longer, we may remember those frightening minutes for the rest of our lives. How many immigrant parents will develop depression and posttraumatic stress disorder?
5. Guards were ordered to be the front-line implementers of the policy and must have been torn between their sworn duty and their inner knowledge that what they are doing is wrong. Hearing the children crying and calling for their parents must have elicited painful feelings of what it would have been like to have their own children taken away with no way to reach them or knowing where they were taken. Implementing this policy dehumanized them, and I believe made them feel guilty or unworthy.
6. Millions of immigrants – whether lawful, dreamers, or undocumented – must have felt fearful, powerless, and angry about this policy. Millions of their children must have been worried and lost a little bit of faith in their parents and in the United States.
7. Did U.S. citizens, many from immigrant roots, wonder if this could happen to them? How many children felt a little less secure? Was the anxiety higher for descendants of the U.S. citizens remembering the trauma of the World War II Japanese internment camps? Other descendants (like me) will remember quite vividly their mother’s story of being on the St. Louis steam ship and being turned away from the United States to face a high likelihood of death in Nazi Germany. A bit of fear will replace trust in and loyalty to the United States.
Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email him at pdnews@mdedge.com.
References:
1. Dev Psychol. 1992;28:759-75.
2. www.cdc.gov/violenceprevention/acestudy/index.html
Biomarker duo rapidly identifies serious bacterial infections
MALMO, SWEDEN – The combination of serum procalcitonin and C-reactive protein levels upon admission to a pediatric ICU displayed high utility for early diagnosis of serious bacterial infection in critically ill children in a large prospective observational study presented at the annual meeting of the European Society for Paediatric Infectious Diseases.
This winning combination significantly outperformed neutrophil gelatinase-associated lipocalin, activated partial thromboplastin time, and resistin, both individually and in various combinations, for the vital task of making a rapid distinction between infectious and noninfectious causes of pediatric systemic inflammatory response syndrome, reported Enitan D. Carrol, MD, professor of pediatric infection at the University of Liverpool (England).
“One of the clinical dilemmas we face in intensive care is being able to differentiate between infectious and noninfectious causes of systemic inflammatory response syndrome. This is important because we need to identify which children have life-threatening infections so that we can promptly initiate antimicrobial therapy,” she explained.
One in four deaths in pediatric ICUs are infection related, Dr. Carrol noted.
“There is an urgent need for infection markers which, firstly, change early in the course of bacterial infection, secondly, correlate with real-time clinical progression, and thirdly, have a rapid turn-around time to allow effective clinical decision making,” she observed.
The combination of procalcitonin and C-reactive protein (CRP) levels measured at admission fits the bill, Dr. Carrol continued. Of the five biomarkers evaluated in her study – all backed by some supporting evidence of efficacy in earlier studies – the top two individual performers in terms of negative predictive value (NPV) were a CRP less than 4.2 mg/dL with a negative NPV of 99%, and a procalcitonin less than 1.52 ng/mL with an NPV of 96%. The positive predictive value of each of the biomarkers was 37%. The sensitivity and specificity of procalcitonin for diagnosis of serious bacterial infection were 78% and 80%, respectively. For CRP, the figures were 93% and 76%.
The combination of procalcitonin and CRP outperformed a multitude of other two-, three-, and four-biomarker combinations tested, with an area under the curve of 93% for combined sensitivity and specificity.
The study included 657 children admitted to the pediatric ICU at Alder Hey Children’s Hospital in Liverpool with systemic inflammatory response syndrome. All had blood samples measured for the five biomarkers on days 1-7. Clinicians were blinded as to the biomarker results. Ninety-two (14%) patients were ultimately found to have a serious bacterial infection – essentially, bacterial meningitis or septic shock – and 565 (86%) had a nonbacterial etiology.
The 28-day mortality rate was 9% in the group with serious bacterial infection, significantly higher than the 2% rate in the group with other causes of their systemic inflammatory response syndrome.
Longitudinal trends in procalcitonin and CRP as evidenced in the study can be used in clinical decision making, according to Dr. Carrol. Mean values of procalcitonin plummeted by 80% from day 1 to day 5 in response to antimicrobial therapy in the group with serious bacterial infections. In contrast, CRP levels rose sharply from day 1 to a peak on day 2, then fell, although the 50% drop from day 2 to day 5 in response to antimicrobial therapy wasn’t as pronounced as the change in procalcitonin.
“There is an additive benefit for both biomarkers compared with CRP alone. The problem with CRP on admission, as I’ve demonstrated in this study, is it often hasn’t risen yet early after admission. So although it gave the best area under the curve of any of the biomarkers, I think that combined with procalcitonin you get a much better descriminator,” Dr. Carrol said.
The median duration of ICU stay in the patients with serious bacterial infection at admission was 5 days, compared with 3 days when the cause of systemic inflammatory response syndrome lay elsewhere. Their median duration of ventilation was significantly longer, too: 4 days versus 2 in children without a serious bacterial infection.
Stepwise logistic regression analysis pinpointed several clinical variables as being associated with prolonged ICU stay.
In addition, initiation of antibiotic therapy prior to admission to the pediatric ICU was associated with a 50% reduction in the likelihood of a prolonged ICU stay. “This reflects the fact that early antibiotics give you a better prognosis if you have sepsis,” according to Dr. Carrol.
She and her coinvestigators now have embarked on a multicenter U.K. study looking at the impact of procalcitonin to guide duration of antimicrobial therapy in critically ill children.
The Alder Hey study was funded by the U.K. National Institute for Health Research. Dr. Carrol reported having no financial conflicts. Although she serves as a consultant to several health care companies, all remuneration goes directly to the University of Liverpool.
MALMO, SWEDEN – The combination of serum procalcitonin and C-reactive protein levels upon admission to a pediatric ICU displayed high utility for early diagnosis of serious bacterial infection in critically ill children in a large prospective observational study presented at the annual meeting of the European Society for Paediatric Infectious Diseases.
This winning combination significantly outperformed neutrophil gelatinase-associated lipocalin, activated partial thromboplastin time, and resistin, both individually and in various combinations, for the vital task of making a rapid distinction between infectious and noninfectious causes of pediatric systemic inflammatory response syndrome, reported Enitan D. Carrol, MD, professor of pediatric infection at the University of Liverpool (England).
“One of the clinical dilemmas we face in intensive care is being able to differentiate between infectious and noninfectious causes of systemic inflammatory response syndrome. This is important because we need to identify which children have life-threatening infections so that we can promptly initiate antimicrobial therapy,” she explained.
One in four deaths in pediatric ICUs are infection related, Dr. Carrol noted.
“There is an urgent need for infection markers which, firstly, change early in the course of bacterial infection, secondly, correlate with real-time clinical progression, and thirdly, have a rapid turn-around time to allow effective clinical decision making,” she observed.
The combination of procalcitonin and C-reactive protein (CRP) levels measured at admission fits the bill, Dr. Carrol continued. Of the five biomarkers evaluated in her study – all backed by some supporting evidence of efficacy in earlier studies – the top two individual performers in terms of negative predictive value (NPV) were a CRP less than 4.2 mg/dL with a negative NPV of 99%, and a procalcitonin less than 1.52 ng/mL with an NPV of 96%. The positive predictive value of each of the biomarkers was 37%. The sensitivity and specificity of procalcitonin for diagnosis of serious bacterial infection were 78% and 80%, respectively. For CRP, the figures were 93% and 76%.
The combination of procalcitonin and CRP outperformed a multitude of other two-, three-, and four-biomarker combinations tested, with an area under the curve of 93% for combined sensitivity and specificity.
The study included 657 children admitted to the pediatric ICU at Alder Hey Children’s Hospital in Liverpool with systemic inflammatory response syndrome. All had blood samples measured for the five biomarkers on days 1-7. Clinicians were blinded as to the biomarker results. Ninety-two (14%) patients were ultimately found to have a serious bacterial infection – essentially, bacterial meningitis or septic shock – and 565 (86%) had a nonbacterial etiology.
The 28-day mortality rate was 9% in the group with serious bacterial infection, significantly higher than the 2% rate in the group with other causes of their systemic inflammatory response syndrome.
Longitudinal trends in procalcitonin and CRP as evidenced in the study can be used in clinical decision making, according to Dr. Carrol. Mean values of procalcitonin plummeted by 80% from day 1 to day 5 in response to antimicrobial therapy in the group with serious bacterial infections. In contrast, CRP levels rose sharply from day 1 to a peak on day 2, then fell, although the 50% drop from day 2 to day 5 in response to antimicrobial therapy wasn’t as pronounced as the change in procalcitonin.
“There is an additive benefit for both biomarkers compared with CRP alone. The problem with CRP on admission, as I’ve demonstrated in this study, is it often hasn’t risen yet early after admission. So although it gave the best area under the curve of any of the biomarkers, I think that combined with procalcitonin you get a much better descriminator,” Dr. Carrol said.
The median duration of ICU stay in the patients with serious bacterial infection at admission was 5 days, compared with 3 days when the cause of systemic inflammatory response syndrome lay elsewhere. Their median duration of ventilation was significantly longer, too: 4 days versus 2 in children without a serious bacterial infection.
Stepwise logistic regression analysis pinpointed several clinical variables as being associated with prolonged ICU stay.
In addition, initiation of antibiotic therapy prior to admission to the pediatric ICU was associated with a 50% reduction in the likelihood of a prolonged ICU stay. “This reflects the fact that early antibiotics give you a better prognosis if you have sepsis,” according to Dr. Carrol.
She and her coinvestigators now have embarked on a multicenter U.K. study looking at the impact of procalcitonin to guide duration of antimicrobial therapy in critically ill children.
The Alder Hey study was funded by the U.K. National Institute for Health Research. Dr. Carrol reported having no financial conflicts. Although she serves as a consultant to several health care companies, all remuneration goes directly to the University of Liverpool.
MALMO, SWEDEN – The combination of serum procalcitonin and C-reactive protein levels upon admission to a pediatric ICU displayed high utility for early diagnosis of serious bacterial infection in critically ill children in a large prospective observational study presented at the annual meeting of the European Society for Paediatric Infectious Diseases.
This winning combination significantly outperformed neutrophil gelatinase-associated lipocalin, activated partial thromboplastin time, and resistin, both individually and in various combinations, for the vital task of making a rapid distinction between infectious and noninfectious causes of pediatric systemic inflammatory response syndrome, reported Enitan D. Carrol, MD, professor of pediatric infection at the University of Liverpool (England).
“One of the clinical dilemmas we face in intensive care is being able to differentiate between infectious and noninfectious causes of systemic inflammatory response syndrome. This is important because we need to identify which children have life-threatening infections so that we can promptly initiate antimicrobial therapy,” she explained.
One in four deaths in pediatric ICUs are infection related, Dr. Carrol noted.
“There is an urgent need for infection markers which, firstly, change early in the course of bacterial infection, secondly, correlate with real-time clinical progression, and thirdly, have a rapid turn-around time to allow effective clinical decision making,” she observed.
The combination of procalcitonin and C-reactive protein (CRP) levels measured at admission fits the bill, Dr. Carrol continued. Of the five biomarkers evaluated in her study – all backed by some supporting evidence of efficacy in earlier studies – the top two individual performers in terms of negative predictive value (NPV) were a CRP less than 4.2 mg/dL with a negative NPV of 99%, and a procalcitonin less than 1.52 ng/mL with an NPV of 96%. The positive predictive value of each of the biomarkers was 37%. The sensitivity and specificity of procalcitonin for diagnosis of serious bacterial infection were 78% and 80%, respectively. For CRP, the figures were 93% and 76%.
The combination of procalcitonin and CRP outperformed a multitude of other two-, three-, and four-biomarker combinations tested, with an area under the curve of 93% for combined sensitivity and specificity.
The study included 657 children admitted to the pediatric ICU at Alder Hey Children’s Hospital in Liverpool with systemic inflammatory response syndrome. All had blood samples measured for the five biomarkers on days 1-7. Clinicians were blinded as to the biomarker results. Ninety-two (14%) patients were ultimately found to have a serious bacterial infection – essentially, bacterial meningitis or septic shock – and 565 (86%) had a nonbacterial etiology.
The 28-day mortality rate was 9% in the group with serious bacterial infection, significantly higher than the 2% rate in the group with other causes of their systemic inflammatory response syndrome.
Longitudinal trends in procalcitonin and CRP as evidenced in the study can be used in clinical decision making, according to Dr. Carrol. Mean values of procalcitonin plummeted by 80% from day 1 to day 5 in response to antimicrobial therapy in the group with serious bacterial infections. In contrast, CRP levels rose sharply from day 1 to a peak on day 2, then fell, although the 50% drop from day 2 to day 5 in response to antimicrobial therapy wasn’t as pronounced as the change in procalcitonin.
“There is an additive benefit for both biomarkers compared with CRP alone. The problem with CRP on admission, as I’ve demonstrated in this study, is it often hasn’t risen yet early after admission. So although it gave the best area under the curve of any of the biomarkers, I think that combined with procalcitonin you get a much better descriminator,” Dr. Carrol said.
The median duration of ICU stay in the patients with serious bacterial infection at admission was 5 days, compared with 3 days when the cause of systemic inflammatory response syndrome lay elsewhere. Their median duration of ventilation was significantly longer, too: 4 days versus 2 in children without a serious bacterial infection.
Stepwise logistic regression analysis pinpointed several clinical variables as being associated with prolonged ICU stay.
In addition, initiation of antibiotic therapy prior to admission to the pediatric ICU was associated with a 50% reduction in the likelihood of a prolonged ICU stay. “This reflects the fact that early antibiotics give you a better prognosis if you have sepsis,” according to Dr. Carrol.
She and her coinvestigators now have embarked on a multicenter U.K. study looking at the impact of procalcitonin to guide duration of antimicrobial therapy in critically ill children.
The Alder Hey study was funded by the U.K. National Institute for Health Research. Dr. Carrol reported having no financial conflicts. Although she serves as a consultant to several health care companies, all remuneration goes directly to the University of Liverpool.
REPORTING FROM ESPID 2018
Key clinical point:
Major finding: The area under the curve combining sensitivity and specificity was 93%.
Study details: This was a prospective, observational, single-center, clinician-blinded study of 657 patients admitted to a pediatric ICU with symptoms of systemic inflammatory response syndrome.
Disclosures: The study was funded by the U.K. National Institute for Health Research. The presenter reported having no relevant financial conflicts. Although she serves as a consultant to several health care companies, all remuneration goes directly to the University of Liverpool.
Mindfulness skill can help in parenting
Behavioral parent management training (PMT), which teaches parents concrete skills to increase their attention to positive behavior and to plan for their response to undesired behavior, has abundant evidence for success for many challenging child behaviors. But sometimes parents have a hard time managing their own emotional responses in the often highly triggering situation of family conflict. Mindfulness has the potential to provide a complement to the PMT skills. Studies are beginning to explore these possibilities.
Case summary
Zoe is a bright 5-year-old who has been “strong willed” and shown intense emotional responses since early in life. The usual 2-year-old temper tantrums increased over time. She has outbursts of yelling, kicking, and hitting, especially with transitions. Her parents tried behavioral parent training, but found it frustrating. If Zoe has been yelling and hitting earlier in the day, her mother feels hurt and angry and can’t bring herself to pay warm attention when Zoe is doing better. When Zoe refuses to pick up her room, her father is flooded with thoughts about his own father hitting him for the slightest disrespect. He thinks that he is a bad, weak father, and sometimes “sees red” and ends up yelling at Zoe instead of putting into place a calm consequence.
Discussion
Mindfulness is defined by Jon Kabat-Zinn as “paying attention in a particular way – on purpose, in the present moment, and nonjudgmentally.” A central feature of mindfulness is strengthening the ability to focus our attention. We learn to pay attention to aspects of the present moment, be that breathing, the sensations in our body, or the experiences of our senses. Often the first skill in behavioral training methods is getting parents to pay attention to their children by participating in child-led play or spending attentive time with older children. This means attending to what the child is doing or talking about rather than jumping in and taking over with suggestions, instructions, or judgments. This meshes very well with this central aspect of mindfulness.
As we practice paying attention, we observe that the mind naturally jumps around from what we mean to be attending to, to a host of distractions, worries, plans, memories, thoughts, and emotions. Mindfulness encourages practitioners to notice these thoughts, to avoid criticizing or judging oneself for becoming involved with these, but instead gently lead the mind back to what you had intended to focus on. This observation of the mind’s activity gives the mindfulness practitioner a bit of space from the thought or emotion itself. We are encouraged to name the thought or emotional processes we notice: “I am worrying, I am planning, I am remembering.”
In the heat of a difficult moment with the child, parents often are flooded with intense emotions (such as anger, fear, anxiety, panic, despair) and thoughts (such as “If my child keeps acting this way he is going to go to jail when he grows up,” “I am a terrible parent,” “Why is my child doing this to me?” or “He is just like his father”). These emotions and thoughts can drive intense, impulsive responses from the parents. As they practice mindfulness, they can gain the ability to observe themselves having these thoughts; observe harsh judgments of themselves or their children or their partners; have some space from them; and realize they may change in a few minutes or realize they may be painful but don’t necessarily have to spur impulsive action. In that moment, parents can give themselves time and space to think through possible actions, and then choose one.
From a behavioral parenting standpoint, we know that parents and humans often react intensely to negative behaviors and inadvertently make them worse with intense emotional reactivity. We want parents to have a plan about how they will respond, to remain calm in the moment, and then put the plan in place. Mindfulness may enhance parents’ ability to notice their own responses and have the space to remember what the plan was and then put it into place. It also can give them space to consider what the child might be experiencing and respond in light of this awareness. This ability does require a significant amount of mindfulness practice.
The combination of mindfulness and parenting is just beginning to be studied in research trials using a range of study designs. Some of these programs have looked at the effect of mindfulness courses, especially mindfulness-based stress reduction without any specific parenting content or indices of parent stress and child behavior. Others have looked at programs which add mindfulness to standard behavioral parenting programs, and still others are specific mindfulness/parenting programs. So far, many of these studies are quasi-experimental in nature. A recent systematic review by Townshend et al. found seven randomized controlled trials of low to moderate quality with some suggestion of ability to decrease parental stress and ADHD symptoms (JBI Database System Rev Implement Rep. 2016 Mar;14[3]:139-80). There is a clear need for randomized controlled trials with larger sample sizes.
While we may not have specific, highly evidence-based mindful parenting programs available, individuals with experience in yoga, meditation, mindfulness, dialectical behavioral therapy, and acceptance and commitment therapy can be encouraged to bring these skills to bear as parents.
Zoe’s parents had pursued outside mindfulness programs. Mindfulness concepts were brought into a standard parenting program. Her parents were encouraged to engage in child-led play with Zoe in a mindful way, fully attending to her actions and experience. Zoe’s parents also were encouraged to observe their own emotional reactions and thoughts in stressful moments and to take a breathing space before taking action.
Dr. Hall is assistant professor of psychiatry and pediatrics at the University of Vermont, Burlington. She said she had no relevant financial disclosures. Email her at pdnews@mdedge.com.
Resources
“Mindful Parenting” (New York: Norton & Co., 2015).
“Integrating mindfulness with parent training: Effects of the mindfulness-enhanced strengthening families program” (Dev Psychol. 2015;51[1]:26-35).
“Everyday blessings: The inner work of mindful parenting,” (New York: Hyperion, 1997).
Behavioral parent management training (PMT), which teaches parents concrete skills to increase their attention to positive behavior and to plan for their response to undesired behavior, has abundant evidence for success for many challenging child behaviors. But sometimes parents have a hard time managing their own emotional responses in the often highly triggering situation of family conflict. Mindfulness has the potential to provide a complement to the PMT skills. Studies are beginning to explore these possibilities.
Case summary
Zoe is a bright 5-year-old who has been “strong willed” and shown intense emotional responses since early in life. The usual 2-year-old temper tantrums increased over time. She has outbursts of yelling, kicking, and hitting, especially with transitions. Her parents tried behavioral parent training, but found it frustrating. If Zoe has been yelling and hitting earlier in the day, her mother feels hurt and angry and can’t bring herself to pay warm attention when Zoe is doing better. When Zoe refuses to pick up her room, her father is flooded with thoughts about his own father hitting him for the slightest disrespect. He thinks that he is a bad, weak father, and sometimes “sees red” and ends up yelling at Zoe instead of putting into place a calm consequence.
Discussion
Mindfulness is defined by Jon Kabat-Zinn as “paying attention in a particular way – on purpose, in the present moment, and nonjudgmentally.” A central feature of mindfulness is strengthening the ability to focus our attention. We learn to pay attention to aspects of the present moment, be that breathing, the sensations in our body, or the experiences of our senses. Often the first skill in behavioral training methods is getting parents to pay attention to their children by participating in child-led play or spending attentive time with older children. This means attending to what the child is doing or talking about rather than jumping in and taking over with suggestions, instructions, or judgments. This meshes very well with this central aspect of mindfulness.
As we practice paying attention, we observe that the mind naturally jumps around from what we mean to be attending to, to a host of distractions, worries, plans, memories, thoughts, and emotions. Mindfulness encourages practitioners to notice these thoughts, to avoid criticizing or judging oneself for becoming involved with these, but instead gently lead the mind back to what you had intended to focus on. This observation of the mind’s activity gives the mindfulness practitioner a bit of space from the thought or emotion itself. We are encouraged to name the thought or emotional processes we notice: “I am worrying, I am planning, I am remembering.”
In the heat of a difficult moment with the child, parents often are flooded with intense emotions (such as anger, fear, anxiety, panic, despair) and thoughts (such as “If my child keeps acting this way he is going to go to jail when he grows up,” “I am a terrible parent,” “Why is my child doing this to me?” or “He is just like his father”). These emotions and thoughts can drive intense, impulsive responses from the parents. As they practice mindfulness, they can gain the ability to observe themselves having these thoughts; observe harsh judgments of themselves or their children or their partners; have some space from them; and realize they may change in a few minutes or realize they may be painful but don’t necessarily have to spur impulsive action. In that moment, parents can give themselves time and space to think through possible actions, and then choose one.
From a behavioral parenting standpoint, we know that parents and humans often react intensely to negative behaviors and inadvertently make them worse with intense emotional reactivity. We want parents to have a plan about how they will respond, to remain calm in the moment, and then put the plan in place. Mindfulness may enhance parents’ ability to notice their own responses and have the space to remember what the plan was and then put it into place. It also can give them space to consider what the child might be experiencing and respond in light of this awareness. This ability does require a significant amount of mindfulness practice.
The combination of mindfulness and parenting is just beginning to be studied in research trials using a range of study designs. Some of these programs have looked at the effect of mindfulness courses, especially mindfulness-based stress reduction without any specific parenting content or indices of parent stress and child behavior. Others have looked at programs which add mindfulness to standard behavioral parenting programs, and still others are specific mindfulness/parenting programs. So far, many of these studies are quasi-experimental in nature. A recent systematic review by Townshend et al. found seven randomized controlled trials of low to moderate quality with some suggestion of ability to decrease parental stress and ADHD symptoms (JBI Database System Rev Implement Rep. 2016 Mar;14[3]:139-80). There is a clear need for randomized controlled trials with larger sample sizes.
While we may not have specific, highly evidence-based mindful parenting programs available, individuals with experience in yoga, meditation, mindfulness, dialectical behavioral therapy, and acceptance and commitment therapy can be encouraged to bring these skills to bear as parents.
Zoe’s parents had pursued outside mindfulness programs. Mindfulness concepts were brought into a standard parenting program. Her parents were encouraged to engage in child-led play with Zoe in a mindful way, fully attending to her actions and experience. Zoe’s parents also were encouraged to observe their own emotional reactions and thoughts in stressful moments and to take a breathing space before taking action.
Dr. Hall is assistant professor of psychiatry and pediatrics at the University of Vermont, Burlington. She said she had no relevant financial disclosures. Email her at pdnews@mdedge.com.
Resources
“Mindful Parenting” (New York: Norton & Co., 2015).
“Integrating mindfulness with parent training: Effects of the mindfulness-enhanced strengthening families program” (Dev Psychol. 2015;51[1]:26-35).
“Everyday blessings: The inner work of mindful parenting,” (New York: Hyperion, 1997).
Behavioral parent management training (PMT), which teaches parents concrete skills to increase their attention to positive behavior and to plan for their response to undesired behavior, has abundant evidence for success for many challenging child behaviors. But sometimes parents have a hard time managing their own emotional responses in the often highly triggering situation of family conflict. Mindfulness has the potential to provide a complement to the PMT skills. Studies are beginning to explore these possibilities.
Case summary
Zoe is a bright 5-year-old who has been “strong willed” and shown intense emotional responses since early in life. The usual 2-year-old temper tantrums increased over time. She has outbursts of yelling, kicking, and hitting, especially with transitions. Her parents tried behavioral parent training, but found it frustrating. If Zoe has been yelling and hitting earlier in the day, her mother feels hurt and angry and can’t bring herself to pay warm attention when Zoe is doing better. When Zoe refuses to pick up her room, her father is flooded with thoughts about his own father hitting him for the slightest disrespect. He thinks that he is a bad, weak father, and sometimes “sees red” and ends up yelling at Zoe instead of putting into place a calm consequence.
Discussion
Mindfulness is defined by Jon Kabat-Zinn as “paying attention in a particular way – on purpose, in the present moment, and nonjudgmentally.” A central feature of mindfulness is strengthening the ability to focus our attention. We learn to pay attention to aspects of the present moment, be that breathing, the sensations in our body, or the experiences of our senses. Often the first skill in behavioral training methods is getting parents to pay attention to their children by participating in child-led play or spending attentive time with older children. This means attending to what the child is doing or talking about rather than jumping in and taking over with suggestions, instructions, or judgments. This meshes very well with this central aspect of mindfulness.
As we practice paying attention, we observe that the mind naturally jumps around from what we mean to be attending to, to a host of distractions, worries, plans, memories, thoughts, and emotions. Mindfulness encourages practitioners to notice these thoughts, to avoid criticizing or judging oneself for becoming involved with these, but instead gently lead the mind back to what you had intended to focus on. This observation of the mind’s activity gives the mindfulness practitioner a bit of space from the thought or emotion itself. We are encouraged to name the thought or emotional processes we notice: “I am worrying, I am planning, I am remembering.”
In the heat of a difficult moment with the child, parents often are flooded with intense emotions (such as anger, fear, anxiety, panic, despair) and thoughts (such as “If my child keeps acting this way he is going to go to jail when he grows up,” “I am a terrible parent,” “Why is my child doing this to me?” or “He is just like his father”). These emotions and thoughts can drive intense, impulsive responses from the parents. As they practice mindfulness, they can gain the ability to observe themselves having these thoughts; observe harsh judgments of themselves or their children or their partners; have some space from them; and realize they may change in a few minutes or realize they may be painful but don’t necessarily have to spur impulsive action. In that moment, parents can give themselves time and space to think through possible actions, and then choose one.
From a behavioral parenting standpoint, we know that parents and humans often react intensely to negative behaviors and inadvertently make them worse with intense emotional reactivity. We want parents to have a plan about how they will respond, to remain calm in the moment, and then put the plan in place. Mindfulness may enhance parents’ ability to notice their own responses and have the space to remember what the plan was and then put it into place. It also can give them space to consider what the child might be experiencing and respond in light of this awareness. This ability does require a significant amount of mindfulness practice.
The combination of mindfulness and parenting is just beginning to be studied in research trials using a range of study designs. Some of these programs have looked at the effect of mindfulness courses, especially mindfulness-based stress reduction without any specific parenting content or indices of parent stress and child behavior. Others have looked at programs which add mindfulness to standard behavioral parenting programs, and still others are specific mindfulness/parenting programs. So far, many of these studies are quasi-experimental in nature. A recent systematic review by Townshend et al. found seven randomized controlled trials of low to moderate quality with some suggestion of ability to decrease parental stress and ADHD symptoms (JBI Database System Rev Implement Rep. 2016 Mar;14[3]:139-80). There is a clear need for randomized controlled trials with larger sample sizes.
While we may not have specific, highly evidence-based mindful parenting programs available, individuals with experience in yoga, meditation, mindfulness, dialectical behavioral therapy, and acceptance and commitment therapy can be encouraged to bring these skills to bear as parents.
Zoe’s parents had pursued outside mindfulness programs. Mindfulness concepts were brought into a standard parenting program. Her parents were encouraged to engage in child-led play with Zoe in a mindful way, fully attending to her actions and experience. Zoe’s parents also were encouraged to observe their own emotional reactions and thoughts in stressful moments and to take a breathing space before taking action.
Dr. Hall is assistant professor of psychiatry and pediatrics at the University of Vermont, Burlington. She said she had no relevant financial disclosures. Email her at pdnews@mdedge.com.
Resources
“Mindful Parenting” (New York: Norton & Co., 2015).
“Integrating mindfulness with parent training: Effects of the mindfulness-enhanced strengthening families program” (Dev Psychol. 2015;51[1]:26-35).
“Everyday blessings: The inner work of mindful parenting,” (New York: Hyperion, 1997).
Pediatric Dermatology Consult - July 2018
Frequently misdiagnosed, streptococcal intertrigo more commonly affects infants and toddlers but is rarely reported, especially compared with other Streptococcus pyogenes infections, including impetigo, erysipelas, and cellulitis.1
Intertrigo, meaning “between” (inter) and “to rub” (terere) in Latin, describes any skin disorder involving two opposing skin surfaces that touch or rub to cause friction.2 The continuous chaffing, coupled with moisture trapped within the skin folds, leads to irritation and maceration, which provides an ideal environment for pathogens to thrive. Thus, frictional dermatitides that arise may become secondarily infected with one or more microorganisms, such as Candida albicans, Staphylococcus aureus, Streptococcus pyogenes, and even organisms less commonly associated with cutaneous infection, such as Proteus mirabilis.3
Streptococcal intertrigo may affect any intertriginous area, but most commonly it affects the folds of the neck; this is likely because of the combination of the deep folds that develop in shorter, infantile necks and the moisture from drool and saliva that pools in the area.5,6 In addition to these cervical folds, other intertriginous areas commonly are affected, including the inguinal, axillary, popliteal, posterior auricular, perianal, and genital folds.
Perianal streptococcal disease may present in a similar manner as streptococcal intertrigo, manifesting as well-demarcated, beefy red plaques in the skin folds around the anus and, in females, frequently perivaginally.7 Unlike streptococcal intertrigo, perianal streptococcal disease is often characterized by pain, pruritus, and fissuring of the involved area.8 It is associated with pharyngeal colonization of group A beta-hemolytic streptococci.7
Diagnosis is straight forward and may be confirmed by a positive streptococcal rapid antigen test of swab specimens of one or more surfaces of affected skin or by culture from a skin swab yielding growth of the organism.1,5 Skin biopsy is not necessary. If the index of suspicion for candida is high, a potassium hydroxide preparation and culture may be performed. Checking serum anti-DNase B antibodies, antistreptolysin O, and pharyngeal cultures is often unrevealing.9 A urinalysis may be performed to assess for poststreptococcal glomerulonephritis if the patient later develops facial or orbital edema, hypertension, hematuria, or lethargy.9
Treatment consists of systemic antistreptococcal therapy; oral amoxicillin and penicillin frequently have been used.9 Moisture in the area should be reduced with application of absorptive powders and physical barriers, such as zinc oxide, after gentle cleansing of the area.5
Other diagnoses to consider when evaluating dermatitides affecting skin folds include: other infectious causes, which may be ruled out by fungal or bacterial culture; inverse psoriasis, which will frequently demonstrate scale; atopic dermatitis, which will be pruritic with history of atopy; irritant or contact dermatitis, which will often have correlating clinical history; seborrheic dermatitis, which will often involve greasiness and scale; and less commonly, acrodermatitis enteropathica, which will be accompanied by diarrhea and hair loss.2,9 Scabies also may be on the differential if the patient endorses severe pruritus with close contacts with similar symptoms.
Ms. Han is a medical student at the University of California, San Diego. Dr. Eichenfield is chief of pediatric and adolescent dermatology at Rady Children’s Hospital–San Diego. He is vice chair of the department of dermatology and a professor of dermatology and pediatrics at the university. They had no conflicts of interest or disclosures to report.
References
1. Pediatr Dermatol. 2014 Mar-Apr;31(2):e71-2.
2. Clin Dermatol. 2011 Mar-Apr;29(2):173-9.
3. Pediatrics. 2003 Dec;112(6 pt 1):1427-9.
4. BMJ Case Rep. 2018 Mar 20. doi: 10.1136/bcr-2018-224179.
5. Pediatr Infect Dis J. 2012 Aug;31(8):872-3.
6. J Pediatr. 2015 May;166(5):1318.
7. J Pediatr. 2015 Sep;167(3):687-93.e1-2.
8. Pediatrics in Review. 1991;12(8):248-55.
9. J Pediatr. 2017 May;184:230-1.e1.
Frequently misdiagnosed, streptococcal intertrigo more commonly affects infants and toddlers but is rarely reported, especially compared with other Streptococcus pyogenes infections, including impetigo, erysipelas, and cellulitis.1
Intertrigo, meaning “between” (inter) and “to rub” (terere) in Latin, describes any skin disorder involving two opposing skin surfaces that touch or rub to cause friction.2 The continuous chaffing, coupled with moisture trapped within the skin folds, leads to irritation and maceration, which provides an ideal environment for pathogens to thrive. Thus, frictional dermatitides that arise may become secondarily infected with one or more microorganisms, such as Candida albicans, Staphylococcus aureus, Streptococcus pyogenes, and even organisms less commonly associated with cutaneous infection, such as Proteus mirabilis.3
Streptococcal intertrigo may affect any intertriginous area, but most commonly it affects the folds of the neck; this is likely because of the combination of the deep folds that develop in shorter, infantile necks and the moisture from drool and saliva that pools in the area.5,6 In addition to these cervical folds, other intertriginous areas commonly are affected, including the inguinal, axillary, popliteal, posterior auricular, perianal, and genital folds.
Perianal streptococcal disease may present in a similar manner as streptococcal intertrigo, manifesting as well-demarcated, beefy red plaques in the skin folds around the anus and, in females, frequently perivaginally.7 Unlike streptococcal intertrigo, perianal streptococcal disease is often characterized by pain, pruritus, and fissuring of the involved area.8 It is associated with pharyngeal colonization of group A beta-hemolytic streptococci.7
Diagnosis is straight forward and may be confirmed by a positive streptococcal rapid antigen test of swab specimens of one or more surfaces of affected skin or by culture from a skin swab yielding growth of the organism.1,5 Skin biopsy is not necessary. If the index of suspicion for candida is high, a potassium hydroxide preparation and culture may be performed. Checking serum anti-DNase B antibodies, antistreptolysin O, and pharyngeal cultures is often unrevealing.9 A urinalysis may be performed to assess for poststreptococcal glomerulonephritis if the patient later develops facial or orbital edema, hypertension, hematuria, or lethargy.9
Treatment consists of systemic antistreptococcal therapy; oral amoxicillin and penicillin frequently have been used.9 Moisture in the area should be reduced with application of absorptive powders and physical barriers, such as zinc oxide, after gentle cleansing of the area.5
Other diagnoses to consider when evaluating dermatitides affecting skin folds include: other infectious causes, which may be ruled out by fungal or bacterial culture; inverse psoriasis, which will frequently demonstrate scale; atopic dermatitis, which will be pruritic with history of atopy; irritant or contact dermatitis, which will often have correlating clinical history; seborrheic dermatitis, which will often involve greasiness and scale; and less commonly, acrodermatitis enteropathica, which will be accompanied by diarrhea and hair loss.2,9 Scabies also may be on the differential if the patient endorses severe pruritus with close contacts with similar symptoms.
Ms. Han is a medical student at the University of California, San Diego. Dr. Eichenfield is chief of pediatric and adolescent dermatology at Rady Children’s Hospital–San Diego. He is vice chair of the department of dermatology and a professor of dermatology and pediatrics at the university. They had no conflicts of interest or disclosures to report.
References
1. Pediatr Dermatol. 2014 Mar-Apr;31(2):e71-2.
2. Clin Dermatol. 2011 Mar-Apr;29(2):173-9.
3. Pediatrics. 2003 Dec;112(6 pt 1):1427-9.
4. BMJ Case Rep. 2018 Mar 20. doi: 10.1136/bcr-2018-224179.
5. Pediatr Infect Dis J. 2012 Aug;31(8):872-3.
6. J Pediatr. 2015 May;166(5):1318.
7. J Pediatr. 2015 Sep;167(3):687-93.e1-2.
8. Pediatrics in Review. 1991;12(8):248-55.
9. J Pediatr. 2017 May;184:230-1.e1.
Frequently misdiagnosed, streptococcal intertrigo more commonly affects infants and toddlers but is rarely reported, especially compared with other Streptococcus pyogenes infections, including impetigo, erysipelas, and cellulitis.1
Intertrigo, meaning “between” (inter) and “to rub” (terere) in Latin, describes any skin disorder involving two opposing skin surfaces that touch or rub to cause friction.2 The continuous chaffing, coupled with moisture trapped within the skin folds, leads to irritation and maceration, which provides an ideal environment for pathogens to thrive. Thus, frictional dermatitides that arise may become secondarily infected with one or more microorganisms, such as Candida albicans, Staphylococcus aureus, Streptococcus pyogenes, and even organisms less commonly associated with cutaneous infection, such as Proteus mirabilis.3
Streptococcal intertrigo may affect any intertriginous area, but most commonly it affects the folds of the neck; this is likely because of the combination of the deep folds that develop in shorter, infantile necks and the moisture from drool and saliva that pools in the area.5,6 In addition to these cervical folds, other intertriginous areas commonly are affected, including the inguinal, axillary, popliteal, posterior auricular, perianal, and genital folds.
Perianal streptococcal disease may present in a similar manner as streptococcal intertrigo, manifesting as well-demarcated, beefy red plaques in the skin folds around the anus and, in females, frequently perivaginally.7 Unlike streptococcal intertrigo, perianal streptococcal disease is often characterized by pain, pruritus, and fissuring of the involved area.8 It is associated with pharyngeal colonization of group A beta-hemolytic streptococci.7
Diagnosis is straight forward and may be confirmed by a positive streptococcal rapid antigen test of swab specimens of one or more surfaces of affected skin or by culture from a skin swab yielding growth of the organism.1,5 Skin biopsy is not necessary. If the index of suspicion for candida is high, a potassium hydroxide preparation and culture may be performed. Checking serum anti-DNase B antibodies, antistreptolysin O, and pharyngeal cultures is often unrevealing.9 A urinalysis may be performed to assess for poststreptococcal glomerulonephritis if the patient later develops facial or orbital edema, hypertension, hematuria, or lethargy.9
Treatment consists of systemic antistreptococcal therapy; oral amoxicillin and penicillin frequently have been used.9 Moisture in the area should be reduced with application of absorptive powders and physical barriers, such as zinc oxide, after gentle cleansing of the area.5
Other diagnoses to consider when evaluating dermatitides affecting skin folds include: other infectious causes, which may be ruled out by fungal or bacterial culture; inverse psoriasis, which will frequently demonstrate scale; atopic dermatitis, which will be pruritic with history of atopy; irritant or contact dermatitis, which will often have correlating clinical history; seborrheic dermatitis, which will often involve greasiness and scale; and less commonly, acrodermatitis enteropathica, which will be accompanied by diarrhea and hair loss.2,9 Scabies also may be on the differential if the patient endorses severe pruritus with close contacts with similar symptoms.
Ms. Han is a medical student at the University of California, San Diego. Dr. Eichenfield is chief of pediatric and adolescent dermatology at Rady Children’s Hospital–San Diego. He is vice chair of the department of dermatology and a professor of dermatology and pediatrics at the university. They had no conflicts of interest or disclosures to report.
References
1. Pediatr Dermatol. 2014 Mar-Apr;31(2):e71-2.
2. Clin Dermatol. 2011 Mar-Apr;29(2):173-9.
3. Pediatrics. 2003 Dec;112(6 pt 1):1427-9.
4. BMJ Case Rep. 2018 Mar 20. doi: 10.1136/bcr-2018-224179.
5. Pediatr Infect Dis J. 2012 Aug;31(8):872-3.
6. J Pediatr. 2015 May;166(5):1318.
7. J Pediatr. 2015 Sep;167(3):687-93.e1-2.
8. Pediatrics in Review. 1991;12(8):248-55.
9. J Pediatr. 2017 May;184:230-1.e1.
An 8-week-old male with a history of cradle cap presented for a second evaluation of an erythematous rash on the neck that started 1.5 weeks before, and it had since worsened. The parents note that their infant has been more irritable, but they otherwise deny any fever, diarrhea, constipation, or decrease in oral intake.
The patient’s first evaluation had been 3 days prior; nystatin cream was prescribed, and the parents applied it twice a day but without improvement to the rash. The patient also had a rash behind the ears bilaterally, which was treated with hydrocortisone 2.5% ointment with some improvement
On physical exam, the central neck is covered by a bright, beefy red, erythematous plaque with distinct borders and strong odor. There is faint scale and superficial desquamation between the skin folds. There are no surrounding papules or pustules. The patient’s chin is moist with drool. In the postauricular skin folds bilaterally, there are fainter but still erythematous plaques with mild scale.
Parents say cancer prevention is the best reason to give HPV vaccine
according to an analysis of a national survey.
Preventing a common infection also ranked highly as a reason for giving the vaccine, as did appeals to the vaccine’s lasting benefits and safety, the analysis showed.
The findings strongly support prioritizing cancer prevention as a reason for HPV vaccination, reported Melissa B. Gilkey, PhD, of the University of North Carolina Gillings School of Global Public Health, Chapel Hill, and her associates.
“To achieve widespread coverage, healthcare providers need strategies for more effectively and efficiently communicating its value,” Dr. Gilkey and her colleagues reported in Cancer Epidemiology, Biomarkers & Prevention.
The findings were based on responses obtained in the Adolescent Cancer Prevention Communication Study, a 2016 online survey completed by 1,259 parents of adolescents.
A total of 1,177 parent were included in this analysis after excluding surveys that were incomplete with regard to questions on provider communication about HPV vaccination.
In the online survey, parents were asked to rank, from best to worst, a list of 11 reasons providers commonly give to encourage parents to consider HPV vaccination for their child.
Overall, parents ranked cancer prevention as the best reason for guideline-consistent HPV vaccination (beta = 2.07), followed by preventing a common infection (beta = 0.68), having lasting benefits (beta = 0.67), and being a safe vaccine (beta = 0.41).
The worst reasons, as ranked by these parents, were “your child is due for it” (beta = –1.08), “I got it for my own child” (beta = –0.98), and “it is a scientific breakthrough” (beta = –0.67).
Researchers hypothesized that parents with low vaccination confidence would have different preferences. While those parents did less often endorse cancer prevention and a few other questions, the variation was minor and resulted in few differences versus the overall parent rankings, according to Dr. Gilkey and her colleagues.
“Although parents with low confidence may find top reasons for HPV vaccination less compelling, they would not necessarily benefit from targeted messaging,” they wrote.
The study was funded by the National Cancer Institute. Dr. Gilkey and coauthors had no potential conflicts of interest to disclose.
SOURCE: Gilkey MB et al. Cancer Epidemiol Biomarkers Prev. 2018 Jul;27(7):762-7.
according to an analysis of a national survey.
Preventing a common infection also ranked highly as a reason for giving the vaccine, as did appeals to the vaccine’s lasting benefits and safety, the analysis showed.
The findings strongly support prioritizing cancer prevention as a reason for HPV vaccination, reported Melissa B. Gilkey, PhD, of the University of North Carolina Gillings School of Global Public Health, Chapel Hill, and her associates.
“To achieve widespread coverage, healthcare providers need strategies for more effectively and efficiently communicating its value,” Dr. Gilkey and her colleagues reported in Cancer Epidemiology, Biomarkers & Prevention.
The findings were based on responses obtained in the Adolescent Cancer Prevention Communication Study, a 2016 online survey completed by 1,259 parents of adolescents.
A total of 1,177 parent were included in this analysis after excluding surveys that were incomplete with regard to questions on provider communication about HPV vaccination.
In the online survey, parents were asked to rank, from best to worst, a list of 11 reasons providers commonly give to encourage parents to consider HPV vaccination for their child.
Overall, parents ranked cancer prevention as the best reason for guideline-consistent HPV vaccination (beta = 2.07), followed by preventing a common infection (beta = 0.68), having lasting benefits (beta = 0.67), and being a safe vaccine (beta = 0.41).
The worst reasons, as ranked by these parents, were “your child is due for it” (beta = –1.08), “I got it for my own child” (beta = –0.98), and “it is a scientific breakthrough” (beta = –0.67).
Researchers hypothesized that parents with low vaccination confidence would have different preferences. While those parents did less often endorse cancer prevention and a few other questions, the variation was minor and resulted in few differences versus the overall parent rankings, according to Dr. Gilkey and her colleagues.
“Although parents with low confidence may find top reasons for HPV vaccination less compelling, they would not necessarily benefit from targeted messaging,” they wrote.
The study was funded by the National Cancer Institute. Dr. Gilkey and coauthors had no potential conflicts of interest to disclose.
SOURCE: Gilkey MB et al. Cancer Epidemiol Biomarkers Prev. 2018 Jul;27(7):762-7.
according to an analysis of a national survey.
Preventing a common infection also ranked highly as a reason for giving the vaccine, as did appeals to the vaccine’s lasting benefits and safety, the analysis showed.
The findings strongly support prioritizing cancer prevention as a reason for HPV vaccination, reported Melissa B. Gilkey, PhD, of the University of North Carolina Gillings School of Global Public Health, Chapel Hill, and her associates.
“To achieve widespread coverage, healthcare providers need strategies for more effectively and efficiently communicating its value,” Dr. Gilkey and her colleagues reported in Cancer Epidemiology, Biomarkers & Prevention.
The findings were based on responses obtained in the Adolescent Cancer Prevention Communication Study, a 2016 online survey completed by 1,259 parents of adolescents.
A total of 1,177 parent were included in this analysis after excluding surveys that were incomplete with regard to questions on provider communication about HPV vaccination.
In the online survey, parents were asked to rank, from best to worst, a list of 11 reasons providers commonly give to encourage parents to consider HPV vaccination for their child.
Overall, parents ranked cancer prevention as the best reason for guideline-consistent HPV vaccination (beta = 2.07), followed by preventing a common infection (beta = 0.68), having lasting benefits (beta = 0.67), and being a safe vaccine (beta = 0.41).
The worst reasons, as ranked by these parents, were “your child is due for it” (beta = –1.08), “I got it for my own child” (beta = –0.98), and “it is a scientific breakthrough” (beta = –0.67).
Researchers hypothesized that parents with low vaccination confidence would have different preferences. While those parents did less often endorse cancer prevention and a few other questions, the variation was minor and resulted in few differences versus the overall parent rankings, according to Dr. Gilkey and her colleagues.
“Although parents with low confidence may find top reasons for HPV vaccination less compelling, they would not necessarily benefit from targeted messaging,” they wrote.
The study was funded by the National Cancer Institute. Dr. Gilkey and coauthors had no potential conflicts of interest to disclose.
SOURCE: Gilkey MB et al. Cancer Epidemiol Biomarkers Prev. 2018 Jul;27(7):762-7.
FROM CANCER EPIDEMIOLOGY, BIOMARKERS & PREVENTION
Key clinical point: Among the reasons health care providers give parents for adolescent HPV vaccination, cancer prevention may be the best.
Major finding: Cancer prevention ranked highest (beta = 2.07), followed by preventing a common infection (beta = 0.68), having lasting benefits (beta = 0.67), and being a safe vaccine (beta = 0.41).
Study details: An analysis of 1,177 responses from parents of adolescents obtained in the Adolescent Cancer Prevention Communication Study, a 2016 online survey.
Disclosures: The study was funded by the National Cancer Institute. Study authors had no potential conflicts of interest to disclose.
Source: Gilkey MB et al. Cancer Epidemiol Biomarkers Prev. 2018 Jul;27(7):762-7.
ACIP votes to recommend new strains for the 2018-2019 flu vaccine
Thirteen members of the Advisory Committee on Immunization Practices (ACIP) voted to approve the influenza vaccine recommendations for 2018-2019, while one member abstained from voting at the summer ACIP meeting.
The 2018-2019 recommendation maintains the core recommendation that influenza vaccines should be administered to all persons 6 months or older who have no contraindications.
FluMist Quadrivalent (LAIV4) also is being updated for the 2018-2019 season. At the February meeting of ACIP, the committee approved language that providers may provide any licensed, age-appropriate influenza vaccine, and LAIV4 is considered in this set of vaccine options.
Prior to this approval, there was a discussion of the safety of the 2017-2018 vaccine. For many of the available vaccines, there were no new safety concerns raised from reports during the flu season. Monitoring during the 2018-2019 will yield more safety monitoring data concerning pregnancy and influenza vaccinations and anaphylaxis in persons with an egg allergy.
The committee’s recommendations must be approved by the Centers for Disease Control and Prevention’s director before they are considered official recommendations.
Thirteen members of the Advisory Committee on Immunization Practices (ACIP) voted to approve the influenza vaccine recommendations for 2018-2019, while one member abstained from voting at the summer ACIP meeting.
The 2018-2019 recommendation maintains the core recommendation that influenza vaccines should be administered to all persons 6 months or older who have no contraindications.
FluMist Quadrivalent (LAIV4) also is being updated for the 2018-2019 season. At the February meeting of ACIP, the committee approved language that providers may provide any licensed, age-appropriate influenza vaccine, and LAIV4 is considered in this set of vaccine options.
Prior to this approval, there was a discussion of the safety of the 2017-2018 vaccine. For many of the available vaccines, there were no new safety concerns raised from reports during the flu season. Monitoring during the 2018-2019 will yield more safety monitoring data concerning pregnancy and influenza vaccinations and anaphylaxis in persons with an egg allergy.
The committee’s recommendations must be approved by the Centers for Disease Control and Prevention’s director before they are considered official recommendations.
Thirteen members of the Advisory Committee on Immunization Practices (ACIP) voted to approve the influenza vaccine recommendations for 2018-2019, while one member abstained from voting at the summer ACIP meeting.
The 2018-2019 recommendation maintains the core recommendation that influenza vaccines should be administered to all persons 6 months or older who have no contraindications.
FluMist Quadrivalent (LAIV4) also is being updated for the 2018-2019 season. At the February meeting of ACIP, the committee approved language that providers may provide any licensed, age-appropriate influenza vaccine, and LAIV4 is considered in this set of vaccine options.
Prior to this approval, there was a discussion of the safety of the 2017-2018 vaccine. For many of the available vaccines, there were no new safety concerns raised from reports during the flu season. Monitoring during the 2018-2019 will yield more safety monitoring data concerning pregnancy and influenza vaccinations and anaphylaxis in persons with an egg allergy.
The committee’s recommendations must be approved by the Centers for Disease Control and Prevention’s director before they are considered official recommendations.
REPORTING FROM AN ACIP MEETING
Preterm infant GER is a normal phenomenon
Treatment of gastroesophageal reflux (GER) in preterm infants with traditional treatments, such as body positioning, and newer treatments with pharmacologic agents appear to be ineffective, and pharmacologic agents in particular may cause significant harm, according to a clinical report by the American Academy of Pediatrics Committee on Fetus and Newborn.
“I think that probably the most important point for any physician, including neonatologists, is that the committee concluded on the basis of the evidence that Eric Eichenwald, MD, lead author of the committee’s clinical report and chief of neonatology at Children’s Hospital of Philadelphia, said in an interview. “So really the bottom line of the clinical report is watchful waiting, conservative management, and patience is the most important approach to a baby that you think is suffering from reflux.”
Pharmacologic management
The committee members focused on four categories of pharmacologic interventions in their report in Pediatrics.
Prokinetic (promotility) agents, such as metoclopramide, domperidone, and erythromycin, are widely used in treating symptoms of GER in older infants and appear to improve gastric emptying, reduce regurgitation, and enhance lower esophageal sphincter tone, but they do not appear to reduce GER symptoms in preterm infants. In addition to not being effective in these infants, there is also a potential for significant adverse events, including cardiac arrhythmia and neurologic side effects. Another common pharmacologic treatment is the use of sodium alginate in combination with sodium bicarbonate. In the presence of gastric acid, sodium alginate precipitates as a gel that forms a physical barrier that protects the gastric mucosa. When sodium bicarbonate is added, a carbon dioxide foam forms that is less harmful to the esophagus than GER-related fluids. While this combination treatment has reduced the number of acidic GER exposures and esophageal acid exposure in preterm infants in small studies, the long-term safety has not been evaluated in this populations.
Histamine2 (H2) blockers, like famotidine and ranitidine, also are commonly prescribed to treat preterm infant gastroesophageal reflux. H2 blockers compete with H2 for the histamine receptors of the parietal cells, which causes a decrease in hydrochloric acid and a subsequent increase in intragastric pH. These are often prescribed on the premise that GER symptoms are secondary to acid reflux in the lower esophagus, but there is no research on the efficacy of H2 blockers on the symptom profile of GER in preterm infants. This class of drugs also has been linked with an increased risk of necrotizing enterocolitis and a higher incidence of late-onset infections and death. This is thought to be caused by alteration of the intestinal microbiome, according to the clinical report.
Proton pump inhibitors (PPIs) are another treatment for reducing acid secretion by the parietal cells, but are largely ineffective in relieving clinical signs of GER in preterm infants. PPIs also have been associated with a higher risk of bacterial overgrowth, gastroenteritis, and community-acquired pneumonia in older children. It is theorized that, because of the acid mitigating effects of PPIs, they will have the potential for adverse effects similar to those seen with H2 blockers, although this has not been investigated.
Traditional treatments
Dr. Eichenwald also was quick to point out that even traditional methods of treating preterm infant GER are not particularly effective.
“Some of the conservative approaches that have been advocated include head-up position and different ways of side-lying to enhance emptying of the stomach after feeding. And none of those have been shown to reduce clinically appreciated signs of reflux in preterm infants. If anything – in term babies – some of those positions have been shown to increase the amount of reflux,” he said in an interview.
“I think that the other important point to make about this is that there are many signs that clinicians attribute to reflux in preterm babies, which include wakefulness, irritability, arching after a feeding. And none of those behaviors have been shown to be associated with reflux when it’s critically examined using either a pH Probe or multichannel impedance monitoring. And therefore the treatments to try to decrease reflux don’t really have an effect on those behaviors either.”
Parental concern
Treating a pediatric issue is not as simple as diagnosis and treatment. Often, parents are justifiably concerned about their children. Dr. Eichenwald sees educating parents as an important facet of treating GER in preterm infants.
“Quite honestly I think that there’s some projection on the part of adults who say, ‘I know how I feel when I have heartburn, which is the adult equivalent of reflux, and the baby must be experiencing the same thing, and that’s why they’re acting uncomfortable,’ ” suggested Dr. Eichenwald. “I think that it’s important for clinicians to educate families that a lot of the signs that we typically have attributed to gastroesophageal reflux are not really related to it.”
With both traditional and pharmacological interventions failing to treat preterm infant GER, Dr. Eichenwald believes that the most effective treatment could be patiently waiting. “I think that the important thing to stress is that reflux is a normal physiologic phenomenon. It rarely causes pathology in preterm infants, and therefore, in treating it, you’re not treating any pathology. You should just be patient and it will likely just go away on its own.”
Dr. Eichenwald has no potential conflicts of interest or external funding to report.
SOURCE: Eichenwald E et al. Pediatrics. 2018 June. doi: 10.1542/peds.2018-1061 .
Treatment of gastroesophageal reflux (GER) in preterm infants with traditional treatments, such as body positioning, and newer treatments with pharmacologic agents appear to be ineffective, and pharmacologic agents in particular may cause significant harm, according to a clinical report by the American Academy of Pediatrics Committee on Fetus and Newborn.
“I think that probably the most important point for any physician, including neonatologists, is that the committee concluded on the basis of the evidence that Eric Eichenwald, MD, lead author of the committee’s clinical report and chief of neonatology at Children’s Hospital of Philadelphia, said in an interview. “So really the bottom line of the clinical report is watchful waiting, conservative management, and patience is the most important approach to a baby that you think is suffering from reflux.”
Pharmacologic management
The committee members focused on four categories of pharmacologic interventions in their report in Pediatrics.
Prokinetic (promotility) agents, such as metoclopramide, domperidone, and erythromycin, are widely used in treating symptoms of GER in older infants and appear to improve gastric emptying, reduce regurgitation, and enhance lower esophageal sphincter tone, but they do not appear to reduce GER symptoms in preterm infants. In addition to not being effective in these infants, there is also a potential for significant adverse events, including cardiac arrhythmia and neurologic side effects. Another common pharmacologic treatment is the use of sodium alginate in combination with sodium bicarbonate. In the presence of gastric acid, sodium alginate precipitates as a gel that forms a physical barrier that protects the gastric mucosa. When sodium bicarbonate is added, a carbon dioxide foam forms that is less harmful to the esophagus than GER-related fluids. While this combination treatment has reduced the number of acidic GER exposures and esophageal acid exposure in preterm infants in small studies, the long-term safety has not been evaluated in this populations.
Histamine2 (H2) blockers, like famotidine and ranitidine, also are commonly prescribed to treat preterm infant gastroesophageal reflux. H2 blockers compete with H2 for the histamine receptors of the parietal cells, which causes a decrease in hydrochloric acid and a subsequent increase in intragastric pH. These are often prescribed on the premise that GER symptoms are secondary to acid reflux in the lower esophagus, but there is no research on the efficacy of H2 blockers on the symptom profile of GER in preterm infants. This class of drugs also has been linked with an increased risk of necrotizing enterocolitis and a higher incidence of late-onset infections and death. This is thought to be caused by alteration of the intestinal microbiome, according to the clinical report.
Proton pump inhibitors (PPIs) are another treatment for reducing acid secretion by the parietal cells, but are largely ineffective in relieving clinical signs of GER in preterm infants. PPIs also have been associated with a higher risk of bacterial overgrowth, gastroenteritis, and community-acquired pneumonia in older children. It is theorized that, because of the acid mitigating effects of PPIs, they will have the potential for adverse effects similar to those seen with H2 blockers, although this has not been investigated.
Traditional treatments
Dr. Eichenwald also was quick to point out that even traditional methods of treating preterm infant GER are not particularly effective.
“Some of the conservative approaches that have been advocated include head-up position and different ways of side-lying to enhance emptying of the stomach after feeding. And none of those have been shown to reduce clinically appreciated signs of reflux in preterm infants. If anything – in term babies – some of those positions have been shown to increase the amount of reflux,” he said in an interview.
“I think that the other important point to make about this is that there are many signs that clinicians attribute to reflux in preterm babies, which include wakefulness, irritability, arching after a feeding. And none of those behaviors have been shown to be associated with reflux when it’s critically examined using either a pH Probe or multichannel impedance monitoring. And therefore the treatments to try to decrease reflux don’t really have an effect on those behaviors either.”
Parental concern
Treating a pediatric issue is not as simple as diagnosis and treatment. Often, parents are justifiably concerned about their children. Dr. Eichenwald sees educating parents as an important facet of treating GER in preterm infants.
“Quite honestly I think that there’s some projection on the part of adults who say, ‘I know how I feel when I have heartburn, which is the adult equivalent of reflux, and the baby must be experiencing the same thing, and that’s why they’re acting uncomfortable,’ ” suggested Dr. Eichenwald. “I think that it’s important for clinicians to educate families that a lot of the signs that we typically have attributed to gastroesophageal reflux are not really related to it.”
With both traditional and pharmacological interventions failing to treat preterm infant GER, Dr. Eichenwald believes that the most effective treatment could be patiently waiting. “I think that the important thing to stress is that reflux is a normal physiologic phenomenon. It rarely causes pathology in preterm infants, and therefore, in treating it, you’re not treating any pathology. You should just be patient and it will likely just go away on its own.”
Dr. Eichenwald has no potential conflicts of interest or external funding to report.
SOURCE: Eichenwald E et al. Pediatrics. 2018 June. doi: 10.1542/peds.2018-1061 .
Treatment of gastroesophageal reflux (GER) in preterm infants with traditional treatments, such as body positioning, and newer treatments with pharmacologic agents appear to be ineffective, and pharmacologic agents in particular may cause significant harm, according to a clinical report by the American Academy of Pediatrics Committee on Fetus and Newborn.
“I think that probably the most important point for any physician, including neonatologists, is that the committee concluded on the basis of the evidence that Eric Eichenwald, MD, lead author of the committee’s clinical report and chief of neonatology at Children’s Hospital of Philadelphia, said in an interview. “So really the bottom line of the clinical report is watchful waiting, conservative management, and patience is the most important approach to a baby that you think is suffering from reflux.”
Pharmacologic management
The committee members focused on four categories of pharmacologic interventions in their report in Pediatrics.
Prokinetic (promotility) agents, such as metoclopramide, domperidone, and erythromycin, are widely used in treating symptoms of GER in older infants and appear to improve gastric emptying, reduce regurgitation, and enhance lower esophageal sphincter tone, but they do not appear to reduce GER symptoms in preterm infants. In addition to not being effective in these infants, there is also a potential for significant adverse events, including cardiac arrhythmia and neurologic side effects. Another common pharmacologic treatment is the use of sodium alginate in combination with sodium bicarbonate. In the presence of gastric acid, sodium alginate precipitates as a gel that forms a physical barrier that protects the gastric mucosa. When sodium bicarbonate is added, a carbon dioxide foam forms that is less harmful to the esophagus than GER-related fluids. While this combination treatment has reduced the number of acidic GER exposures and esophageal acid exposure in preterm infants in small studies, the long-term safety has not been evaluated in this populations.
Histamine2 (H2) blockers, like famotidine and ranitidine, also are commonly prescribed to treat preterm infant gastroesophageal reflux. H2 blockers compete with H2 for the histamine receptors of the parietal cells, which causes a decrease in hydrochloric acid and a subsequent increase in intragastric pH. These are often prescribed on the premise that GER symptoms are secondary to acid reflux in the lower esophagus, but there is no research on the efficacy of H2 blockers on the symptom profile of GER in preterm infants. This class of drugs also has been linked with an increased risk of necrotizing enterocolitis and a higher incidence of late-onset infections and death. This is thought to be caused by alteration of the intestinal microbiome, according to the clinical report.
Proton pump inhibitors (PPIs) are another treatment for reducing acid secretion by the parietal cells, but are largely ineffective in relieving clinical signs of GER in preterm infants. PPIs also have been associated with a higher risk of bacterial overgrowth, gastroenteritis, and community-acquired pneumonia in older children. It is theorized that, because of the acid mitigating effects of PPIs, they will have the potential for adverse effects similar to those seen with H2 blockers, although this has not been investigated.
Traditional treatments
Dr. Eichenwald also was quick to point out that even traditional methods of treating preterm infant GER are not particularly effective.
“Some of the conservative approaches that have been advocated include head-up position and different ways of side-lying to enhance emptying of the stomach after feeding. And none of those have been shown to reduce clinically appreciated signs of reflux in preterm infants. If anything – in term babies – some of those positions have been shown to increase the amount of reflux,” he said in an interview.
“I think that the other important point to make about this is that there are many signs that clinicians attribute to reflux in preterm babies, which include wakefulness, irritability, arching after a feeding. And none of those behaviors have been shown to be associated with reflux when it’s critically examined using either a pH Probe or multichannel impedance monitoring. And therefore the treatments to try to decrease reflux don’t really have an effect on those behaviors either.”
Parental concern
Treating a pediatric issue is not as simple as diagnosis and treatment. Often, parents are justifiably concerned about their children. Dr. Eichenwald sees educating parents as an important facet of treating GER in preterm infants.
“Quite honestly I think that there’s some projection on the part of adults who say, ‘I know how I feel when I have heartburn, which is the adult equivalent of reflux, and the baby must be experiencing the same thing, and that’s why they’re acting uncomfortable,’ ” suggested Dr. Eichenwald. “I think that it’s important for clinicians to educate families that a lot of the signs that we typically have attributed to gastroesophageal reflux are not really related to it.”
With both traditional and pharmacological interventions failing to treat preterm infant GER, Dr. Eichenwald believes that the most effective treatment could be patiently waiting. “I think that the important thing to stress is that reflux is a normal physiologic phenomenon. It rarely causes pathology in preterm infants, and therefore, in treating it, you’re not treating any pathology. You should just be patient and it will likely just go away on its own.”
Dr. Eichenwald has no potential conflicts of interest or external funding to report.
SOURCE: Eichenwald E et al. Pediatrics. 2018 June. doi: 10.1542/peds.2018-1061 .
FROM PEDIATRICS