Pediatrics

The Food and Drug Administration said Feb. 11 it would delay a decision on authorizing the use of the Pfizer vaccine for younger children until data on the effects of three doses is available.

Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said the plan for a meeting the week of Feb. 14 of the FDA’s Vaccines and Related Biological Products Advisory Committee was to “understand if two doses would provide sufficient protection to move forward.”

Pfizer has asked the FDA to authorize the use of its mRNA vaccine for children under the age of 5. But, Dr. Marks said, “in looking through the data we realized now … that at this time it makes sense for us to wait until we have the data of the evaluation of a third dose before taking action.”

The Food and Drug Administration said Feb. 11 it would delay a decision on authorizing the use of the Pfizer vaccine for younger children until data on the effects of three doses is available.

Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said the plan for a meeting the week of Feb. 14 of the FDA’s Vaccines and Related Biological Products Advisory Committee was to “understand if two doses would provide sufficient protection to move forward.”

Pfizer has asked the FDA to authorize the use of its mRNA vaccine for children under the age of 5. But, Dr. Marks said, “in looking through the data we realized now … that at this time it makes sense for us to wait until we have the data of the evaluation of a third dose before taking action.”

The Food and Drug Administration said Feb. 11 it would delay a decision on authorizing the use of the Pfizer vaccine for younger children until data on the effects of three doses is available.

Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said the plan for a meeting the week of Feb. 14 of the FDA’s Vaccines and Related Biological Products Advisory Committee was to “understand if two doses would provide sufficient protection to move forward.”

Pfizer has asked the FDA to authorize the use of its mRNA vaccine for children under the age of 5. But, Dr. Marks said, “in looking through the data we realized now … that at this time it makes sense for us to wait until we have the data of the evaluation of a third dose before taking action.”

Current interventions to tackle Staphylococcus aureus in patients with atopic eczema have little impact on symptoms, based on data from a Cochrane Review of 41 studies published in Clinical and Experimental Allergy.

Eczema remains a huge disease burden worldwide, and colonization with S. aureus in eczema patients is common, but no standard intervention exists to relieve symptoms, wrote Nandini Banerjee, MD, of Addenbrooke’s Hospital, Cambridge, England. “While antibiotic treatment of clinically obvious infections such as cellulitis is beneficial, it is not clear whether antibiotic treatment of eczema influences eczema severity,” Dr. Banerjee noted.

The 41 studies included 1,753 participants and 10 treatment categories. Most of the studies were conducted in secondary care centers in Western Europe, North America, and the Far East. Twelve studies included children, four included only adults, 19 included children and adults, and in six studies, the participant age range was unclear. Among the studies with reported ages, the mean age ranged from 1.1 to 34.6 years. Eczema severity ranged from mild to severe, and treatment durations ranged from 10 minutes to 3 months.

The review presented comparisons of topical steroid/antibiotic combinations, oral antibiotics, and bleach baths. In 14 studies that compared topical steroid/antibiotic combinations to topical steroids alone, patients showed slightly greater global improvement in symptoms with the combination, but the impact on quality of life was not significantly different. Severe adverse events, including flare of dermatitis, worsening of eczema, and folliculitis, were reported by the patients who received the combination and the topical steroid–only patients. One study reported similar rates of antibiotic resistance in children treated with steroid only and with an antibiotic/steroid combination at 3 months’ follow-up.

In four studies, oral antibiotics “may make no difference in terms of good or excellent global improvement in infants and children at 14 to 28 days follow-up compared to placebo,” according to the review. The reviewers said that there was likely little or no difference in quality of life for infants and children given oral antibiotics, although they noted the low quality of evidence on this topic.

Five studies evaluated the impact of bleach baths on eczema patients with and without S. aureus infections. These studies showed no difference in global improvement measures compared with placebo and little or no difference in quality of life. Also, patients who underwent bleach baths compared with placebo patients reported similar adverse events of burning/stinging or dry skin at 2 months’ follow-up.

“Low-quality evidence, due to risk of bias, imprecise effect estimates, and heterogeneity, made pooling of results difficult,” Dr. Banerjee wrote. “Topical steroid/antibiotic combinations may be associated with possible small improvements in good or excellent signs/symptoms compared with topical steroid alone. High-quality trials evaluating efficacy, QOL, and antibiotic resistance are required,” she concluded.

In a commentary section after the review, Dr. Banerjee and colleagues noted that the United Kingdom’s NICE guidelines for managing atopic eczema in children younger than 12 years of age, published in March 2021, include evidence from the current updated Cochrane Review. The NICE guidelines emphasize that “in people who are not systemically unwell, clinicians should not routinely offer either a topical or oral antibiotic for secondary bacterial infection of eczema,” the Cochrane authors said. They added in their commentary that the use of antibiotics in cases of nonsevere infections can worsen eczema. Also, “the risk of antimicrobial resistance is high with topical antibiotics, and therefore extended doses of the same antibiotics should be avoided to prevent resistance,” they said. However, the authors acknowledged a role for antibiotics in certain situations. “In patients with systemic signs of infection such as cellulitis, systemic antibiotics have an important role in helping clear infection,” they noted.

Reasons for varying disease severity elude research

The current study is important because of the abundance of preclinical and clinical data that implicate S. aureus in atopic dermatitis pathogenesis, Brian Kim, MD, of the Icahn School of Medicine at Mount Sinai, New York, said in an interview.

Dr. Kim said that he was surprised by some of the study findings but not others. “On the one hand, I thought there would be data supporting antimicrobial therapy, albeit not strong support,” he said. “However, AD is a very complex disease, and understanding what a disease modifier does to it is hard to capture across studies of various different designs,” he said.

“The data supporting antimicrobial therapy for S. aureus in AD is not as clear as our clinical impressions may indicate,” said Dr. Kim. “We need to understand the relationship better, perhaps in particular subsets of patients,” he emphasized. In addition, “We need a better understanding of why some people are colonized with S. aureus, yet with little effect on AD itself, while others experience severe exacerbation of disease,” said Dr. Kim. Therefore, a key research question for future studies is whether the exacerbation is caused by the particular strain of the bug, the host susceptibility, or both, he said.

The review received no outside funding. Dr. Banerjee and Dr. Kim have disclosed that they had no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Current interventions to tackle Staphylococcus aureus in patients with atopic eczema have little impact on symptoms, based on data from a Cochrane Review of 41 studies published in Clinical and Experimental Allergy.

Eczema remains a huge disease burden worldwide, and colonization with S. aureus in eczema patients is common, but no standard intervention exists to relieve symptoms, wrote Nandini Banerjee, MD, of Addenbrooke’s Hospital, Cambridge, England. “While antibiotic treatment of clinically obvious infections such as cellulitis is beneficial, it is not clear whether antibiotic treatment of eczema influences eczema severity,” Dr. Banerjee noted.

The 41 studies included 1,753 participants and 10 treatment categories. Most of the studies were conducted in secondary care centers in Western Europe, North America, and the Far East. Twelve studies included children, four included only adults, 19 included children and adults, and in six studies, the participant age range was unclear. Among the studies with reported ages, the mean age ranged from 1.1 to 34.6 years. Eczema severity ranged from mild to severe, and treatment durations ranged from 10 minutes to 3 months.

The review presented comparisons of topical steroid/antibiotic combinations, oral antibiotics, and bleach baths. In 14 studies that compared topical steroid/antibiotic combinations to topical steroids alone, patients showed slightly greater global improvement in symptoms with the combination, but the impact on quality of life was not significantly different. Severe adverse events, including flare of dermatitis, worsening of eczema, and folliculitis, were reported by the patients who received the combination and the topical steroid–only patients. One study reported similar rates of antibiotic resistance in children treated with steroid only and with an antibiotic/steroid combination at 3 months’ follow-up.

In four studies, oral antibiotics “may make no difference in terms of good or excellent global improvement in infants and children at 14 to 28 days follow-up compared to placebo,” according to the review. The reviewers said that there was likely little or no difference in quality of life for infants and children given oral antibiotics, although they noted the low quality of evidence on this topic.

Five studies evaluated the impact of bleach baths on eczema patients with and without S. aureus infections. These studies showed no difference in global improvement measures compared with placebo and little or no difference in quality of life. Also, patients who underwent bleach baths compared with placebo patients reported similar adverse events of burning/stinging or dry skin at 2 months’ follow-up.

“Low-quality evidence, due to risk of bias, imprecise effect estimates, and heterogeneity, made pooling of results difficult,” Dr. Banerjee wrote. “Topical steroid/antibiotic combinations may be associated with possible small improvements in good or excellent signs/symptoms compared with topical steroid alone. High-quality trials evaluating efficacy, QOL, and antibiotic resistance are required,” she concluded.

In a commentary section after the review, Dr. Banerjee and colleagues noted that the United Kingdom’s NICE guidelines for managing atopic eczema in children younger than 12 years of age, published in March 2021, include evidence from the current updated Cochrane Review. The NICE guidelines emphasize that “in people who are not systemically unwell, clinicians should not routinely offer either a topical or oral antibiotic for secondary bacterial infection of eczema,” the Cochrane authors said. They added in their commentary that the use of antibiotics in cases of nonsevere infections can worsen eczema. Also, “the risk of antimicrobial resistance is high with topical antibiotics, and therefore extended doses of the same antibiotics should be avoided to prevent resistance,” they said. However, the authors acknowledged a role for antibiotics in certain situations. “In patients with systemic signs of infection such as cellulitis, systemic antibiotics have an important role in helping clear infection,” they noted.

Reasons for varying disease severity elude research

The current study is important because of the abundance of preclinical and clinical data that implicate S. aureus in atopic dermatitis pathogenesis, Brian Kim, MD, of the Icahn School of Medicine at Mount Sinai, New York, said in an interview.

Dr. Kim said that he was surprised by some of the study findings but not others. “On the one hand, I thought there would be data supporting antimicrobial therapy, albeit not strong support,” he said. “However, AD is a very complex disease, and understanding what a disease modifier does to it is hard to capture across studies of various different designs,” he said.

“The data supporting antimicrobial therapy for S. aureus in AD is not as clear as our clinical impressions may indicate,” said Dr. Kim. “We need to understand the relationship better, perhaps in particular subsets of patients,” he emphasized. In addition, “We need a better understanding of why some people are colonized with S. aureus, yet with little effect on AD itself, while others experience severe exacerbation of disease,” said Dr. Kim. Therefore, a key research question for future studies is whether the exacerbation is caused by the particular strain of the bug, the host susceptibility, or both, he said.

The review received no outside funding. Dr. Banerjee and Dr. Kim have disclosed that they had no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Current interventions to tackle Staphylococcus aureus in patients with atopic eczema have little impact on symptoms, based on data from a Cochrane Review of 41 studies published in Clinical and Experimental Allergy.

Eczema remains a huge disease burden worldwide, and colonization with S. aureus in eczema patients is common, but no standard intervention exists to relieve symptoms, wrote Nandini Banerjee, MD, of Addenbrooke’s Hospital, Cambridge, England. “While antibiotic treatment of clinically obvious infections such as cellulitis is beneficial, it is not clear whether antibiotic treatment of eczema influences eczema severity,” Dr. Banerjee noted.

The 41 studies included 1,753 participants and 10 treatment categories. Most of the studies were conducted in secondary care centers in Western Europe, North America, and the Far East. Twelve studies included children, four included only adults, 19 included children and adults, and in six studies, the participant age range was unclear. Among the studies with reported ages, the mean age ranged from 1.1 to 34.6 years. Eczema severity ranged from mild to severe, and treatment durations ranged from 10 minutes to 3 months.

The review presented comparisons of topical steroid/antibiotic combinations, oral antibiotics, and bleach baths. In 14 studies that compared topical steroid/antibiotic combinations to topical steroids alone, patients showed slightly greater global improvement in symptoms with the combination, but the impact on quality of life was not significantly different. Severe adverse events, including flare of dermatitis, worsening of eczema, and folliculitis, were reported by the patients who received the combination and the topical steroid–only patients. One study reported similar rates of antibiotic resistance in children treated with steroid only and with an antibiotic/steroid combination at 3 months’ follow-up.

In four studies, oral antibiotics “may make no difference in terms of good or excellent global improvement in infants and children at 14 to 28 days follow-up compared to placebo,” according to the review. The reviewers said that there was likely little or no difference in quality of life for infants and children given oral antibiotics, although they noted the low quality of evidence on this topic.

Five studies evaluated the impact of bleach baths on eczema patients with and without S. aureus infections. These studies showed no difference in global improvement measures compared with placebo and little or no difference in quality of life. Also, patients who underwent bleach baths compared with placebo patients reported similar adverse events of burning/stinging or dry skin at 2 months’ follow-up.

“Low-quality evidence, due to risk of bias, imprecise effect estimates, and heterogeneity, made pooling of results difficult,” Dr. Banerjee wrote. “Topical steroid/antibiotic combinations may be associated with possible small improvements in good or excellent signs/symptoms compared with topical steroid alone. High-quality trials evaluating efficacy, QOL, and antibiotic resistance are required,” she concluded.

In a commentary section after the review, Dr. Banerjee and colleagues noted that the United Kingdom’s NICE guidelines for managing atopic eczema in children younger than 12 years of age, published in March 2021, include evidence from the current updated Cochrane Review. The NICE guidelines emphasize that “in people who are not systemically unwell, clinicians should not routinely offer either a topical or oral antibiotic for secondary bacterial infection of eczema,” the Cochrane authors said. They added in their commentary that the use of antibiotics in cases of nonsevere infections can worsen eczema. Also, “the risk of antimicrobial resistance is high with topical antibiotics, and therefore extended doses of the same antibiotics should be avoided to prevent resistance,” they said. However, the authors acknowledged a role for antibiotics in certain situations. “In patients with systemic signs of infection such as cellulitis, systemic antibiotics have an important role in helping clear infection,” they noted.

Reasons for varying disease severity elude research

The current study is important because of the abundance of preclinical and clinical data that implicate S. aureus in atopic dermatitis pathogenesis, Brian Kim, MD, of the Icahn School of Medicine at Mount Sinai, New York, said in an interview.

Dr. Kim said that he was surprised by some of the study findings but not others. “On the one hand, I thought there would be data supporting antimicrobial therapy, albeit not strong support,” he said. “However, AD is a very complex disease, and understanding what a disease modifier does to it is hard to capture across studies of various different designs,” he said.

“The data supporting antimicrobial therapy for S. aureus in AD is not as clear as our clinical impressions may indicate,” said Dr. Kim. “We need to understand the relationship better, perhaps in particular subsets of patients,” he emphasized. In addition, “We need a better understanding of why some people are colonized with S. aureus, yet with little effect on AD itself, while others experience severe exacerbation of disease,” said Dr. Kim. Therefore, a key research question for future studies is whether the exacerbation is caused by the particular strain of the bug, the host susceptibility, or both, he said.

The review received no outside funding. Dr. Banerjee and Dr. Kim have disclosed that they had no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Recent evidence has shown that women who contract COVID-19 during pregnancy are at increased risk for pregnancy loss and neonatal death. Now, an analysis of pathology data from dozens of perinatal deaths shows how.

Unlike numerous pathogens that kill the fetus by infecting it directly, SARS-CoV-2 causes “widespread and severe” destruction of the placenta that deprives the fetus of oxygen, a team of 44 researchers in 12 countries concluded after examining 64 stillbirths and four neonatal deaths in which the placentas were infected with the virus. They noted that such damage occurs in a small percentage of pregnant women with COVID and that all the women in the study had not been vaccinated against the disease.

The findings were published online Feb. 10 in the Archives of Pathology & Laboratory Medicine.

Nearly all placentas had each of three features that pathologists have dubbed SARS-CoV-2 placentitis: large deposits of fibrin, a clotting protein that obstructs the flow of blood, death of cells in the trophoblast, and an unusual form of inflammation called chronic histiocytic intervillositis. Some had other abnormalities that could have exacerbated the condition.

The researchers called the extent of damage “striking,” affecting 77.7% of the placenta on average. The virus did not appear to harm fetal tissue, but placental damage “was extensive and highly destructive,” they write. Notably, none of the women in the analysis were known to have severe COVID.
 

Virus seen ‘chewing up the placenta’

David Schwartz, MD, a pathologist in Atlanta, and the lead author of the study, said COVID appears to be unique in destroying the placenta.

“I don’t know of any infection that does that to this degree or with this uniformity,” Dr. Schwartz told this news organization. “The simple message is that this infection is chewing up the placenta and destroying its capability to oxygenate the fetus.”

In November, the Centers for Disease Control and Prevention reported that maternal COVID increases the risk of losing a pregnancy. From March 2020 to September 2021, 8,154 stillbirths were reported, affecting 0.65% of births by women without COVID and 1.26% of births by women with COVID, for a relative risk of 1.90 (95% confidence interval, 1.69-2.15).

Delta, the variant that dominated in mid-2021, appears to have been particularly harmful. The CDC reported that the relative risk for stillbirth for mothers with COVID-19 during that period increased to 4.04 (95% CI, 3.28-4.97). Many cases in the new analysis coincided with Delta.

Dr. Schwartz and his colleagues said immunization, along with antiviral therapy, might reduce the chance of SARS-CoV-2 infecting the placenta. None of the mothers in the analysis was vaccinated, and Dr. Schwartz said he is not aware of a single case in a vaccinated woman.

The analysis comes on the heels of a study from the National Institutes of Health linking severe to moderate COVID infection to greater risk of other pregnancy complications: cesarean and preterm delivery, death during childbirth, postpartum hemorrhaging, and non-COVID infections.

Diana Bianchi, MD, director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, said those findings underscore the need for pregnant women to be vaccinated. (The shots have been shown to be safe for pregnant women.)

Denise Jamieson, MD, MPH, chair of the department of gynecology and obstetrics at Emory University, Atlanta, who was not involved in the new analysis, said the findings may have important clinical implications. In addition to ensuring that pregnant patients are fully vaccinated, she said “there may be opportunities to more closely monitor the placenta during pregnancy using imaging modalities such as ultrasound.”

Even in the presence of severe abnormalities, a fetus that has reached a viable gestational age could potentially be delivered prior to stillbirth, Dr. Jamieson said. The 64 stillbirths in the analysis ranged from 15 to 39.2 weeks of gestation, with an average of 30 weeks. Eight were delivered at full term.

However, additional studies are needed to support monitoring of placental changes, she said: “It is not ready for prime time now.”

Christopher Zahn, MD, vice president of practice activities the American College of Obstetricians and Gynecologists, cautioned that data on COVID and pregnancy complications remain limited.

The findings in this analysis “do not prove the association between COVID-19 infection and neonatal outcomes,” Dr. Zahn said. “While stillbirth could potentially be another adverse outcome for pregnant people who contract COVID-19, currently we don’t have enough data to confirm that a COVID-19 infection at any point in pregnancy indicates increased risk of stillbirth.”

He added that ACOG continues to strongly recommend vaccination against COVID for women who are pregnant, recently pregnant, or planning to be pregnant.

Dr. Schwartz and Dr. Jamieson have disclosed no relevant financial relationships. One author reported receiving financial support from the Slovak Research and Development Agency. Another reported funding from the Belgian Fund for Scientific Research and the Fetus for Life charity.

A version of this article first appeared on Medscape.com.

Recent evidence has shown that women who contract COVID-19 during pregnancy are at increased risk for pregnancy loss and neonatal death. Now, an analysis of pathology data from dozens of perinatal deaths shows how.

Unlike numerous pathogens that kill the fetus by infecting it directly, SARS-CoV-2 causes “widespread and severe” destruction of the placenta that deprives the fetus of oxygen, a team of 44 researchers in 12 countries concluded after examining 64 stillbirths and four neonatal deaths in which the placentas were infected with the virus. They noted that such damage occurs in a small percentage of pregnant women with COVID and that all the women in the study had not been vaccinated against the disease.

The findings were published online Feb. 10 in the Archives of Pathology & Laboratory Medicine.

Nearly all placentas had each of three features that pathologists have dubbed SARS-CoV-2 placentitis: large deposits of fibrin, a clotting protein that obstructs the flow of blood, death of cells in the trophoblast, and an unusual form of inflammation called chronic histiocytic intervillositis. Some had other abnormalities that could have exacerbated the condition.

The researchers called the extent of damage “striking,” affecting 77.7% of the placenta on average. The virus did not appear to harm fetal tissue, but placental damage “was extensive and highly destructive,” they write. Notably, none of the women in the analysis were known to have severe COVID.
 

Virus seen ‘chewing up the placenta’

David Schwartz, MD, a pathologist in Atlanta, and the lead author of the study, said COVID appears to be unique in destroying the placenta.

“I don’t know of any infection that does that to this degree or with this uniformity,” Dr. Schwartz told this news organization. “The simple message is that this infection is chewing up the placenta and destroying its capability to oxygenate the fetus.”

In November, the Centers for Disease Control and Prevention reported that maternal COVID increases the risk of losing a pregnancy. From March 2020 to September 2021, 8,154 stillbirths were reported, affecting 0.65% of births by women without COVID and 1.26% of births by women with COVID, for a relative risk of 1.90 (95% confidence interval, 1.69-2.15).

Delta, the variant that dominated in mid-2021, appears to have been particularly harmful. The CDC reported that the relative risk for stillbirth for mothers with COVID-19 during that period increased to 4.04 (95% CI, 3.28-4.97). Many cases in the new analysis coincided with Delta.

Dr. Schwartz and his colleagues said immunization, along with antiviral therapy, might reduce the chance of SARS-CoV-2 infecting the placenta. None of the mothers in the analysis was vaccinated, and Dr. Schwartz said he is not aware of a single case in a vaccinated woman.

The analysis comes on the heels of a study from the National Institutes of Health linking severe to moderate COVID infection to greater risk of other pregnancy complications: cesarean and preterm delivery, death during childbirth, postpartum hemorrhaging, and non-COVID infections.

Diana Bianchi, MD, director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, said those findings underscore the need for pregnant women to be vaccinated. (The shots have been shown to be safe for pregnant women.)

Denise Jamieson, MD, MPH, chair of the department of gynecology and obstetrics at Emory University, Atlanta, who was not involved in the new analysis, said the findings may have important clinical implications. In addition to ensuring that pregnant patients are fully vaccinated, she said “there may be opportunities to more closely monitor the placenta during pregnancy using imaging modalities such as ultrasound.”

Even in the presence of severe abnormalities, a fetus that has reached a viable gestational age could potentially be delivered prior to stillbirth, Dr. Jamieson said. The 64 stillbirths in the analysis ranged from 15 to 39.2 weeks of gestation, with an average of 30 weeks. Eight were delivered at full term.

However, additional studies are needed to support monitoring of placental changes, she said: “It is not ready for prime time now.”

Christopher Zahn, MD, vice president of practice activities the American College of Obstetricians and Gynecologists, cautioned that data on COVID and pregnancy complications remain limited.

The findings in this analysis “do not prove the association between COVID-19 infection and neonatal outcomes,” Dr. Zahn said. “While stillbirth could potentially be another adverse outcome for pregnant people who contract COVID-19, currently we don’t have enough data to confirm that a COVID-19 infection at any point in pregnancy indicates increased risk of stillbirth.”

He added that ACOG continues to strongly recommend vaccination against COVID for women who are pregnant, recently pregnant, or planning to be pregnant.

Dr. Schwartz and Dr. Jamieson have disclosed no relevant financial relationships. One author reported receiving financial support from the Slovak Research and Development Agency. Another reported funding from the Belgian Fund for Scientific Research and the Fetus for Life charity.

A version of this article first appeared on Medscape.com.

Recent evidence has shown that women who contract COVID-19 during pregnancy are at increased risk for pregnancy loss and neonatal death. Now, an analysis of pathology data from dozens of perinatal deaths shows how.

Unlike numerous pathogens that kill the fetus by infecting it directly, SARS-CoV-2 causes “widespread and severe” destruction of the placenta that deprives the fetus of oxygen, a team of 44 researchers in 12 countries concluded after examining 64 stillbirths and four neonatal deaths in which the placentas were infected with the virus. They noted that such damage occurs in a small percentage of pregnant women with COVID and that all the women in the study had not been vaccinated against the disease.

The findings were published online Feb. 10 in the Archives of Pathology & Laboratory Medicine.

Nearly all placentas had each of three features that pathologists have dubbed SARS-CoV-2 placentitis: large deposits of fibrin, a clotting protein that obstructs the flow of blood, death of cells in the trophoblast, and an unusual form of inflammation called chronic histiocytic intervillositis. Some had other abnormalities that could have exacerbated the condition.

The researchers called the extent of damage “striking,” affecting 77.7% of the placenta on average. The virus did not appear to harm fetal tissue, but placental damage “was extensive and highly destructive,” they write. Notably, none of the women in the analysis were known to have severe COVID.
 

Virus seen ‘chewing up the placenta’

David Schwartz, MD, a pathologist in Atlanta, and the lead author of the study, said COVID appears to be unique in destroying the placenta.

“I don’t know of any infection that does that to this degree or with this uniformity,” Dr. Schwartz told this news organization. “The simple message is that this infection is chewing up the placenta and destroying its capability to oxygenate the fetus.”

In November, the Centers for Disease Control and Prevention reported that maternal COVID increases the risk of losing a pregnancy. From March 2020 to September 2021, 8,154 stillbirths were reported, affecting 0.65% of births by women without COVID and 1.26% of births by women with COVID, for a relative risk of 1.90 (95% confidence interval, 1.69-2.15).

Delta, the variant that dominated in mid-2021, appears to have been particularly harmful. The CDC reported that the relative risk for stillbirth for mothers with COVID-19 during that period increased to 4.04 (95% CI, 3.28-4.97). Many cases in the new analysis coincided with Delta.

Dr. Schwartz and his colleagues said immunization, along with antiviral therapy, might reduce the chance of SARS-CoV-2 infecting the placenta. None of the mothers in the analysis was vaccinated, and Dr. Schwartz said he is not aware of a single case in a vaccinated woman.

The analysis comes on the heels of a study from the National Institutes of Health linking severe to moderate COVID infection to greater risk of other pregnancy complications: cesarean and preterm delivery, death during childbirth, postpartum hemorrhaging, and non-COVID infections.

Diana Bianchi, MD, director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, said those findings underscore the need for pregnant women to be vaccinated. (The shots have been shown to be safe for pregnant women.)

Denise Jamieson, MD, MPH, chair of the department of gynecology and obstetrics at Emory University, Atlanta, who was not involved in the new analysis, said the findings may have important clinical implications. In addition to ensuring that pregnant patients are fully vaccinated, she said “there may be opportunities to more closely monitor the placenta during pregnancy using imaging modalities such as ultrasound.”

Even in the presence of severe abnormalities, a fetus that has reached a viable gestational age could potentially be delivered prior to stillbirth, Dr. Jamieson said. The 64 stillbirths in the analysis ranged from 15 to 39.2 weeks of gestation, with an average of 30 weeks. Eight were delivered at full term.

However, additional studies are needed to support monitoring of placental changes, she said: “It is not ready for prime time now.”

Christopher Zahn, MD, vice president of practice activities the American College of Obstetricians and Gynecologists, cautioned that data on COVID and pregnancy complications remain limited.

The findings in this analysis “do not prove the association between COVID-19 infection and neonatal outcomes,” Dr. Zahn said. “While stillbirth could potentially be another adverse outcome for pregnant people who contract COVID-19, currently we don’t have enough data to confirm that a COVID-19 infection at any point in pregnancy indicates increased risk of stillbirth.”

He added that ACOG continues to strongly recommend vaccination against COVID for women who are pregnant, recently pregnant, or planning to be pregnant.

Dr. Schwartz and Dr. Jamieson have disclosed no relevant financial relationships. One author reported receiving financial support from the Slovak Research and Development Agency. Another reported funding from the Belgian Fund for Scientific Research and the Fetus for Life charity.

A version of this article first appeared on Medscape.com.

Enteral feeding kits pose a risk for strangulation in children, according to a safety alert from the U.S. Food and Drug Administration. The safety alert was prompted by two deaths linked to the medical devices.

The alert cites the deaths in 2021 of two toddlers who were strangled by tubes in the feeding sets that had become wrapped around their necks.

Clinicians should discuss the risk of strangulation with colleagues and caregivers and encourage them to take steps to keep tubing away from children as much as possible, the agency advised in a Feb. 8, 2022, safety communication.

A version of this article first appeared on Medscape.com.

Enteral feeding kits pose a risk for strangulation in children, according to a safety alert from the U.S. Food and Drug Administration. The safety alert was prompted by two deaths linked to the medical devices.

The alert cites the deaths in 2021 of two toddlers who were strangled by tubes in the feeding sets that had become wrapped around their necks.

Clinicians should discuss the risk of strangulation with colleagues and caregivers and encourage them to take steps to keep tubing away from children as much as possible, the agency advised in a Feb. 8, 2022, safety communication.

A version of this article first appeared on Medscape.com.

Enteral feeding kits pose a risk for strangulation in children, according to a safety alert from the U.S. Food and Drug Administration. The safety alert was prompted by two deaths linked to the medical devices.

The alert cites the deaths in 2021 of two toddlers who were strangled by tubes in the feeding sets that had become wrapped around their necks.

Clinicians should discuss the risk of strangulation with colleagues and caregivers and encourage them to take steps to keep tubing away from children as much as possible, the agency advised in a Feb. 8, 2022, safety communication.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has accepted a supplemental Biologics License Application (sBLA) for Priority Review of dupilumab to treat moderate to severe atopic dermatitis (AD) in children aged 6 months to 5 years, according to a statement from the manufacturers, Regeneron and Sanofi.

If approved, dupilumab would be the first biologic approved for children in this age group in the United States, according to the statement. The proposed indication is as add-on therapy for children with moderate to severe AD not adequately controlled with topical prescription therapies or for whom topical therapies are not advised. The FDA granted breakthrough therapy designation for dupilumab for the treatment of severe AD in children aged 6 months to 11 years in 2016.

Approximately 85%-95% of atopic dermatitis patients develop symptoms before 5 years of age, and these symptoms often continue into adulthood, with an increased risk of skin infections and a significant impact on quality of life, according to the statement.

The sBLA is based on data from a phase 3 pivotal study of 162 children aged 6 months to 5 years in which dupilumab was added to standard-of-care topical corticosteroids, presented in December 2021. In the study, dupilumab plus standard of care significantly improved skin clearance and reduced overall disease severity and itch at 16 weeks compared with standard of care alone. Overall, 28% of the children randomized to dupilumab achieved the primary endpoint of clear or almost-clear skin, compared with 4% with those on standard of care alone (P < .0001), according to the manufacturers. Patients in the dupilumab group received either 200 mg (for children weighing ≥ 5 to < 15 kg) or 300 mg (for children weighing ≥ 15 to < 30 kg) every 4 weeks. Safety results were similar to those seen with dupilumab for children aged 6 years and older.

Conjunctivitis and herpes infections were among the most common adverse events associated with dupilumab in the study, according to the statement.

The target action date for the FDA decision on this application is June 9, 2022.

The Food and Drug Administration has accepted a supplemental Biologics License Application (sBLA) for Priority Review of dupilumab to treat moderate to severe atopic dermatitis (AD) in children aged 6 months to 5 years, according to a statement from the manufacturers, Regeneron and Sanofi.

If approved, dupilumab would be the first biologic approved for children in this age group in the United States, according to the statement. The proposed indication is as add-on therapy for children with moderate to severe AD not adequately controlled with topical prescription therapies or for whom topical therapies are not advised. The FDA granted breakthrough therapy designation for dupilumab for the treatment of severe AD in children aged 6 months to 11 years in 2016.

Approximately 85%-95% of atopic dermatitis patients develop symptoms before 5 years of age, and these symptoms often continue into adulthood, with an increased risk of skin infections and a significant impact on quality of life, according to the statement.

The sBLA is based on data from a phase 3 pivotal study of 162 children aged 6 months to 5 years in which dupilumab was added to standard-of-care topical corticosteroids, presented in December 2021. In the study, dupilumab plus standard of care significantly improved skin clearance and reduced overall disease severity and itch at 16 weeks compared with standard of care alone. Overall, 28% of the children randomized to dupilumab achieved the primary endpoint of clear or almost-clear skin, compared with 4% with those on standard of care alone (P < .0001), according to the manufacturers. Patients in the dupilumab group received either 200 mg (for children weighing ≥ 5 to < 15 kg) or 300 mg (for children weighing ≥ 15 to < 30 kg) every 4 weeks. Safety results were similar to those seen with dupilumab for children aged 6 years and older.

Conjunctivitis and herpes infections were among the most common adverse events associated with dupilumab in the study, according to the statement.

The target action date for the FDA decision on this application is June 9, 2022.

The Food and Drug Administration has accepted a supplemental Biologics License Application (sBLA) for Priority Review of dupilumab to treat moderate to severe atopic dermatitis (AD) in children aged 6 months to 5 years, according to a statement from the manufacturers, Regeneron and Sanofi.

If approved, dupilumab would be the first biologic approved for children in this age group in the United States, according to the statement. The proposed indication is as add-on therapy for children with moderate to severe AD not adequately controlled with topical prescription therapies or for whom topical therapies are not advised. The FDA granted breakthrough therapy designation for dupilumab for the treatment of severe AD in children aged 6 months to 11 years in 2016.

Approximately 85%-95% of atopic dermatitis patients develop symptoms before 5 years of age, and these symptoms often continue into adulthood, with an increased risk of skin infections and a significant impact on quality of life, according to the statement.

The sBLA is based on data from a phase 3 pivotal study of 162 children aged 6 months to 5 years in which dupilumab was added to standard-of-care topical corticosteroids, presented in December 2021. In the study, dupilumab plus standard of care significantly improved skin clearance and reduced overall disease severity and itch at 16 weeks compared with standard of care alone. Overall, 28% of the children randomized to dupilumab achieved the primary endpoint of clear or almost-clear skin, compared with 4% with those on standard of care alone (P < .0001), according to the manufacturers. Patients in the dupilumab group received either 200 mg (for children weighing ≥ 5 to < 15 kg) or 300 mg (for children weighing ≥ 15 to < 30 kg) every 4 weeks. Safety results were similar to those seen with dupilumab for children aged 6 years and older.

Conjunctivitis and herpes infections were among the most common adverse events associated with dupilumab in the study, according to the statement.

The target action date for the FDA decision on this application is June 9, 2022.

Faster gains in weight, length or height, or body mass index in the first 5 years of life were associated with an earlier onset of puberty in boys and girls, based on data from a cohort study of more than 7,000 children.

In recent decades, clinicians and parents have raised concerns about an earlier onset of puberty in children in the United States and other countries, Izzudin M. Aris, PhD, of Harvard Medical School, Boston, and colleagues wrote.

“Children with earlier pubertal onset not only may be at increased risk for long-term chronic diseases, but also may experience adverse consequences during adolescence, including psychosocial difficulties and dysmetabolism,” they said. However, the effect of growth in the first 5 years of life on pubertal onset has not been well studied.

In a study published in JAMA Network Open, the researchers identified 7,495 children from 36 cohorts participating in the Environmental Influences on Child Health Outcomes program from Jan. 1, 1986, to Dec. 31, 2015.

The study population included 3,772 girls and 3,723 boys; 60% reported as White, 23% as Black, 15% as Hispanic, 12% as one of the following: American Indian or Alaska Native, Native Hawaiian or Pacific Islander, multiple races, or other race. Most (84.1%) were born during or after the year 2000.

The primary outcome was the pubertal growth spurt, also known as age at peak height velocity (APHV). The researchers measured growth at 3 age periods in the first 5 years (early infancy, late infancy, and early childhood) and estimated rates of weight, length or height, and body mass index (BMI) gain. Secondary outcomes included self-reported pubic hair staging and scores on the Pubertal Development Scale.

Overall, weight and length or height gain velocities declined in the first 5 years of life, and boys had faster gains in early infancy, compared with girls.

APHV was negatively correlated with puberty scores and Tanner staging for pubic hair development in both boys and girls, while puberty score was positively correlated with Tanner staging for pubic hair in both sexes.

After controlling for maternal and child confounders including maternal age at delivery, maternal education level, and year of birth, faster gains in weight, length or height, or BMI at each of the three measurement periods in early life was associated with earlier APHV in boys. No effect was noted for race, maternal education level, or birth year.

In girls, faster gains in weight, length, or height, only at the latest measurement period (early childhood) were associated with younger APHV. No associations with APHV occurred for velocities of BMI gain at any age period in girls, the researchers noted. However, age at menarche was positively correlated with early APHV and negatively correlated with puberty score and Tanner staging for pubic hair.

The findings support previous studies of associations between child growth and pubertal onset, the researchers wrote. The mechanisms of action are many, and have not been explained, the researchers wrote in their discussion of the findings.

“We speculate that insulinlike growth factor 1 may be a factor in the associations observed in the present study, either directly or indirectly through sex steroid synthesis and secretion. Alternatively, in girls, androgens and adipokines may be factors in the observed associations for pubic hair staging and menarche, respectively,” they said. Genetics and other factors including social factors, environmental exposures, diet, and physical activity also affect growth in early life.

The study findings were limited by several factors including the use of child-reported measures of pubic hair staging and parent reports of pubertal scores, with the potential for error and misclassification, the researchers noted. Other limitations include a lack of data on maternal age at menarche and the use of weight-for-length rather than BMI for children younger than 2 years.

However, the results were strengthened by the large sample size, long-term follow-up, and especially the use of a nationally representative contemporary cohort that addresses gaps in the current literature from later time periods. The results support the associations of sex-specific early pubertal onset in children with faster growth early in life. “In the long term, results of the present study may inform future research that aims to develop and/or test preventive interventions to optimize nutrition, environmental exposures, physical activity, and other behaviors related to growth during these age periods,” they concluded.

Time and timing limit practical application of results

The current study addresses two issues that are ongoing concerns for clinicians, specifically, the rise in obesity in childhood and its potential link to an earlier age of entry into puberty, M. Susan Jay, MD, of the Medical College of Wisconsin, Milwaukee, said in an interview.

“Authors in prior studies have suggested that earlier puberty, and indeed earlier menarche, in females may be associated with the potential of long-term health issues,” Dr. Jay noted. “It has also been suggested that both early maturing females and males may be impacted psychosocially. Others have suggested that the pathways through puberty are key and environmental factors as well as nutrition can have an impact on adolescence as well as health consequences later in life.”

The current study is important because it focused on children born in the present era of the obesity epidemic, while earlier studies were conducted on a group in the 1960s-1980s. “This study suggests that there are sex-specific associations of faster growth and earlier entry into puberty,” Dr. Jay said.

“While it is exciting to consider closer monitoring of pubertal progression in pediatric settings, often patients and families do not present in a timely manner for assessment,” she said. “Also, the authors suggest that preventive support may be offered to children who are traversing puberty at earlier ages. However, given the current stress on practices with COVID as well as stress on providers offering clinical services, identifying supportive interventions may be a stretch at best for practitioners already burdened by clinical and administrative demands.

“Ongoing studies are needed to address the knowledge gaps that exist in the arena of pubertal onset and growth during childhood across life periods,” said Dr. Jay. “In the long term, the present study may help direct research that could focus on preventive interventions to optimize nutrition, physical activity, environmental exposures, and other factors that intersect growth during infancy through early childhood, which may hasten early pubertal development’s later sequelae in adulthood.”

The study was supported by various grants to the researchers from the Environmental Influences on Child Health Outcomes program, Office of the Director, National Institutes of Health, as well as the Colorado Clinical and Translational Sciences Institute, University of Colorado at Denver. Lead author Dr. Aris had no financial conflicts to disclose. Dr. Jay had no conflicts to disclose and serves on the editorial advisory board of Pediatric News.

Faster gains in weight, length or height, or body mass index in the first 5 years of life were associated with an earlier onset of puberty in boys and girls, based on data from a cohort study of more than 7,000 children.

In recent decades, clinicians and parents have raised concerns about an earlier onset of puberty in children in the United States and other countries, Izzudin M. Aris, PhD, of Harvard Medical School, Boston, and colleagues wrote.

“Children with earlier pubertal onset not only may be at increased risk for long-term chronic diseases, but also may experience adverse consequences during adolescence, including psychosocial difficulties and dysmetabolism,” they said. However, the effect of growth in the first 5 years of life on pubertal onset has not been well studied.

In a study published in JAMA Network Open, the researchers identified 7,495 children from 36 cohorts participating in the Environmental Influences on Child Health Outcomes program from Jan. 1, 1986, to Dec. 31, 2015.

The study population included 3,772 girls and 3,723 boys; 60% reported as White, 23% as Black, 15% as Hispanic, 12% as one of the following: American Indian or Alaska Native, Native Hawaiian or Pacific Islander, multiple races, or other race. Most (84.1%) were born during or after the year 2000.

The primary outcome was the pubertal growth spurt, also known as age at peak height velocity (APHV). The researchers measured growth at 3 age periods in the first 5 years (early infancy, late infancy, and early childhood) and estimated rates of weight, length or height, and body mass index (BMI) gain. Secondary outcomes included self-reported pubic hair staging and scores on the Pubertal Development Scale.

Overall, weight and length or height gain velocities declined in the first 5 years of life, and boys had faster gains in early infancy, compared with girls.

APHV was negatively correlated with puberty scores and Tanner staging for pubic hair development in both boys and girls, while puberty score was positively correlated with Tanner staging for pubic hair in both sexes.

After controlling for maternal and child confounders including maternal age at delivery, maternal education level, and year of birth, faster gains in weight, length or height, or BMI at each of the three measurement periods in early life was associated with earlier APHV in boys. No effect was noted for race, maternal education level, or birth year.

In girls, faster gains in weight, length, or height, only at the latest measurement period (early childhood) were associated with younger APHV. No associations with APHV occurred for velocities of BMI gain at any age period in girls, the researchers noted. However, age at menarche was positively correlated with early APHV and negatively correlated with puberty score and Tanner staging for pubic hair.

The findings support previous studies of associations between child growth and pubertal onset, the researchers wrote. The mechanisms of action are many, and have not been explained, the researchers wrote in their discussion of the findings.

“We speculate that insulinlike growth factor 1 may be a factor in the associations observed in the present study, either directly or indirectly through sex steroid synthesis and secretion. Alternatively, in girls, androgens and adipokines may be factors in the observed associations for pubic hair staging and menarche, respectively,” they said. Genetics and other factors including social factors, environmental exposures, diet, and physical activity also affect growth in early life.

The study findings were limited by several factors including the use of child-reported measures of pubic hair staging and parent reports of pubertal scores, with the potential for error and misclassification, the researchers noted. Other limitations include a lack of data on maternal age at menarche and the use of weight-for-length rather than BMI for children younger than 2 years.

However, the results were strengthened by the large sample size, long-term follow-up, and especially the use of a nationally representative contemporary cohort that addresses gaps in the current literature from later time periods. The results support the associations of sex-specific early pubertal onset in children with faster growth early in life. “In the long term, results of the present study may inform future research that aims to develop and/or test preventive interventions to optimize nutrition, environmental exposures, physical activity, and other behaviors related to growth during these age periods,” they concluded.

Time and timing limit practical application of results

The current study addresses two issues that are ongoing concerns for clinicians, specifically, the rise in obesity in childhood and its potential link to an earlier age of entry into puberty, M. Susan Jay, MD, of the Medical College of Wisconsin, Milwaukee, said in an interview.

“Authors in prior studies have suggested that earlier puberty, and indeed earlier menarche, in females may be associated with the potential of long-term health issues,” Dr. Jay noted. “It has also been suggested that both early maturing females and males may be impacted psychosocially. Others have suggested that the pathways through puberty are key and environmental factors as well as nutrition can have an impact on adolescence as well as health consequences later in life.”

The current study is important because it focused on children born in the present era of the obesity epidemic, while earlier studies were conducted on a group in the 1960s-1980s. “This study suggests that there are sex-specific associations of faster growth and earlier entry into puberty,” Dr. Jay said.

“While it is exciting to consider closer monitoring of pubertal progression in pediatric settings, often patients and families do not present in a timely manner for assessment,” she said. “Also, the authors suggest that preventive support may be offered to children who are traversing puberty at earlier ages. However, given the current stress on practices with COVID as well as stress on providers offering clinical services, identifying supportive interventions may be a stretch at best for practitioners already burdened by clinical and administrative demands.

“Ongoing studies are needed to address the knowledge gaps that exist in the arena of pubertal onset and growth during childhood across life periods,” said Dr. Jay. “In the long term, the present study may help direct research that could focus on preventive interventions to optimize nutrition, physical activity, environmental exposures, and other factors that intersect growth during infancy through early childhood, which may hasten early pubertal development’s later sequelae in adulthood.”

The study was supported by various grants to the researchers from the Environmental Influences on Child Health Outcomes program, Office of the Director, National Institutes of Health, as well as the Colorado Clinical and Translational Sciences Institute, University of Colorado at Denver. Lead author Dr. Aris had no financial conflicts to disclose. Dr. Jay had no conflicts to disclose and serves on the editorial advisory board of Pediatric News.

Faster gains in weight, length or height, or body mass index in the first 5 years of life were associated with an earlier onset of puberty in boys and girls, based on data from a cohort study of more than 7,000 children.

In recent decades, clinicians and parents have raised concerns about an earlier onset of puberty in children in the United States and other countries, Izzudin M. Aris, PhD, of Harvard Medical School, Boston, and colleagues wrote.

“Children with earlier pubertal onset not only may be at increased risk for long-term chronic diseases, but also may experience adverse consequences during adolescence, including psychosocial difficulties and dysmetabolism,” they said. However, the effect of growth in the first 5 years of life on pubertal onset has not been well studied.

In a study published in JAMA Network Open, the researchers identified 7,495 children from 36 cohorts participating in the Environmental Influences on Child Health Outcomes program from Jan. 1, 1986, to Dec. 31, 2015.

The study population included 3,772 girls and 3,723 boys; 60% reported as White, 23% as Black, 15% as Hispanic, 12% as one of the following: American Indian or Alaska Native, Native Hawaiian or Pacific Islander, multiple races, or other race. Most (84.1%) were born during or after the year 2000.

The primary outcome was the pubertal growth spurt, also known as age at peak height velocity (APHV). The researchers measured growth at 3 age periods in the first 5 years (early infancy, late infancy, and early childhood) and estimated rates of weight, length or height, and body mass index (BMI) gain. Secondary outcomes included self-reported pubic hair staging and scores on the Pubertal Development Scale.

Overall, weight and length or height gain velocities declined in the first 5 years of life, and boys had faster gains in early infancy, compared with girls.

APHV was negatively correlated with puberty scores and Tanner staging for pubic hair development in both boys and girls, while puberty score was positively correlated with Tanner staging for pubic hair in both sexes.

After controlling for maternal and child confounders including maternal age at delivery, maternal education level, and year of birth, faster gains in weight, length or height, or BMI at each of the three measurement periods in early life was associated with earlier APHV in boys. No effect was noted for race, maternal education level, or birth year.

In girls, faster gains in weight, length, or height, only at the latest measurement period (early childhood) were associated with younger APHV. No associations with APHV occurred for velocities of BMI gain at any age period in girls, the researchers noted. However, age at menarche was positively correlated with early APHV and negatively correlated with puberty score and Tanner staging for pubic hair.

The findings support previous studies of associations between child growth and pubertal onset, the researchers wrote. The mechanisms of action are many, and have not been explained, the researchers wrote in their discussion of the findings.

“We speculate that insulinlike growth factor 1 may be a factor in the associations observed in the present study, either directly or indirectly through sex steroid synthesis and secretion. Alternatively, in girls, androgens and adipokines may be factors in the observed associations for pubic hair staging and menarche, respectively,” they said. Genetics and other factors including social factors, environmental exposures, diet, and physical activity also affect growth in early life.

The study findings were limited by several factors including the use of child-reported measures of pubic hair staging and parent reports of pubertal scores, with the potential for error and misclassification, the researchers noted. Other limitations include a lack of data on maternal age at menarche and the use of weight-for-length rather than BMI for children younger than 2 years.

However, the results were strengthened by the large sample size, long-term follow-up, and especially the use of a nationally representative contemporary cohort that addresses gaps in the current literature from later time periods. The results support the associations of sex-specific early pubertal onset in children with faster growth early in life. “In the long term, results of the present study may inform future research that aims to develop and/or test preventive interventions to optimize nutrition, environmental exposures, physical activity, and other behaviors related to growth during these age periods,” they concluded.

Time and timing limit practical application of results

The current study addresses two issues that are ongoing concerns for clinicians, specifically, the rise in obesity in childhood and its potential link to an earlier age of entry into puberty, M. Susan Jay, MD, of the Medical College of Wisconsin, Milwaukee, said in an interview.

“Authors in prior studies have suggested that earlier puberty, and indeed earlier menarche, in females may be associated with the potential of long-term health issues,” Dr. Jay noted. “It has also been suggested that both early maturing females and males may be impacted psychosocially. Others have suggested that the pathways through puberty are key and environmental factors as well as nutrition can have an impact on adolescence as well as health consequences later in life.”

The current study is important because it focused on children born in the present era of the obesity epidemic, while earlier studies were conducted on a group in the 1960s-1980s. “This study suggests that there are sex-specific associations of faster growth and earlier entry into puberty,” Dr. Jay said.

“While it is exciting to consider closer monitoring of pubertal progression in pediatric settings, often patients and families do not present in a timely manner for assessment,” she said. “Also, the authors suggest that preventive support may be offered to children who are traversing puberty at earlier ages. However, given the current stress on practices with COVID as well as stress on providers offering clinical services, identifying supportive interventions may be a stretch at best for practitioners already burdened by clinical and administrative demands.

“Ongoing studies are needed to address the knowledge gaps that exist in the arena of pubertal onset and growth during childhood across life periods,” said Dr. Jay. “In the long term, the present study may help direct research that could focus on preventive interventions to optimize nutrition, physical activity, environmental exposures, and other factors that intersect growth during infancy through early childhood, which may hasten early pubertal development’s later sequelae in adulthood.”

The study was supported by various grants to the researchers from the Environmental Influences on Child Health Outcomes program, Office of the Director, National Institutes of Health, as well as the Colorado Clinical and Translational Sciences Institute, University of Colorado at Denver. Lead author Dr. Aris had no financial conflicts to disclose. Dr. Jay had no conflicts to disclose and serves on the editorial advisory board of Pediatric News.

Researchers evaluating whether endometriosis is linked with preterm birth found no such association in a multicenter cohort study of more than 1300 women.

These new findings, which were published online in JAMA Network Open, suggest that changing monitoring strategies to prevent preterm birth for women with the disease may not be necessary.

The research team, led by Louis Marcellin, MD, PhD, with the department of obstetrics and gynecology at Université de Paris, also found that disease phenotype or whether the preterm birth was induced or spontaneous did not appear to alter the result.

Those results differ from previous research. Data on the phenotypes and their link with preterm birth have been scarce, but previous studies have shown the risk for preterm birth is more pronounced in women who have deep endometriosis than in women with ovarian endometriosis.

Dr. Marcellin said in an interview that “little is known about the impact of endometriosis on obstetric outcomes. In contrast to previous studies, we reported no differences in the risk for preterm delivery between women with endometriosis (34 of 470 [7.2%]) and those without endometriosis (53 of 881 [6.0%]), even when adjusted for multiple factors.”

The authors accounted for mother’s age, body mass index before pregnancy, birth country, number of times the woman had given birth, previous cesarean delivery, and history of preterm birth. After adjusting for potential confounders, endometriosis was not associated with preterm birth (adjusted odds ratio, 1.07; 95% confidence interval, 0.64-1.77).

The researchers found no differences among preterm births based on a mother’s endometriosis phenotype. Those phenotypes include Isolated superficial peritoneal endometriosis, ovarian endometrioma, and deep endometriosis.

“Monitoring pregnancy beyond the normal protocols or changing management strategies may not be warranted in cases of endometriosis,” Dr. Marcellin said.

More research on endometriosis’ potential link to birth outcomes is needed.

An expert not involved with the study said the new paper highlights important new avenues of research but should not be seen as the final word on the connection between endometriosis and preterm birth.

Of the 1,351 study participants (mean age, 32.9 years) who had a singleton delivery after 22 weeks’ gestation, 470 were assigned to the endometriosis group, and 881 were assigned to the control group.

The authors concluded that “pregnant women with endometriosis should not be considered to have an exceptionally high risk for preterm birth. However, further studies are needed to examine the potential for other adverse perinatal outcomes or specific but rare complications.”

Daniela Carusi, MD, said the difficulty with the study’s design is that “premature birth is not one problem or one disease.”

Many very different problems can all end with premature birth. Sometimes it’s an infection or inflammation or bleeding in the uterus or hypertension in the mother, for example, and all those things can lead to a preterm birth, she explained.

“This study inherently lumps all those things together,” said Dr. Carusi, who is director of surgical obstetrics and placental abnormalities in the department of obstetrics and gynecology at Brigham and Women’s Hospital, Boston. “It’s quite possible endometriosis can have a big impact in one of those areas and no impact in the other areas, but the study design wouldn’t be able to pick that up.”
 

Editorialists: Results challenge findings of previous studies

In an accompanying commentary, Liisu Saavalainen, MD, PhD, and Oskari Heikinheimo, MD, PhD, both with the department of obstetrics and gynecology, Helsinki University Hospital, wrote that several previous studies have suggested that women with endometriosis have a slightly higher risk for preterm birth.

Those studies were mostly retrospective and differed in the way they classified endometriosis and the way they selected patients, the editorialists write. Also, most women in these studies typically had subfertility, they added.

The study by Dr. Marcellin and colleagues differs from previous related research in that was prospective and assessed the risk for preterm delivery in women both with endometriosis and those without endometriosis from several maternity centers in France. The women with endometriosis were classified according to the severity of their disease.

The editorialists wrote: “The novel results by Marcellin et al. challenge the findings of most previous studies on this topic. These results are valuable and comforting. However, they are also likely to trigger new studies on the pregnancy risks associated with different types of endometriosis. That is good news.”

Dr. Carusi said the study was well done and included a notably large size. Further complimenting the research, she said it’s important to talk about this little-discussed pregnancy complication. There’s been much more focus for women with endometriosis and their physicians on getting pregnant and on talking about the length of their term.

The study leaves some things unanswered.

The study was funded by research grants from the French Ministry of Health and was sponsored by the Département de la Recherche Clinique et du Développement de l’Assistance Publique–Hôpitaux de Paris. Dr. Carusi reported no relevant financial relationships. One study coauthor reported receiving personal fees from Bioserinity and Ferring outside the submitted work. No other disclosures were reported.

A version of this article first appeared on Medscape.com.

Researchers evaluating whether endometriosis is linked with preterm birth found no such association in a multicenter cohort study of more than 1300 women.

These new findings, which were published online in JAMA Network Open, suggest that changing monitoring strategies to prevent preterm birth for women with the disease may not be necessary.

The research team, led by Louis Marcellin, MD, PhD, with the department of obstetrics and gynecology at Université de Paris, also found that disease phenotype or whether the preterm birth was induced or spontaneous did not appear to alter the result.

Those results differ from previous research. Data on the phenotypes and their link with preterm birth have been scarce, but previous studies have shown the risk for preterm birth is more pronounced in women who have deep endometriosis than in women with ovarian endometriosis.

Dr. Marcellin said in an interview that “little is known about the impact of endometriosis on obstetric outcomes. In contrast to previous studies, we reported no differences in the risk for preterm delivery between women with endometriosis (34 of 470 [7.2%]) and those without endometriosis (53 of 881 [6.0%]), even when adjusted for multiple factors.”

The authors accounted for mother’s age, body mass index before pregnancy, birth country, number of times the woman had given birth, previous cesarean delivery, and history of preterm birth. After adjusting for potential confounders, endometriosis was not associated with preterm birth (adjusted odds ratio, 1.07; 95% confidence interval, 0.64-1.77).

The researchers found no differences among preterm births based on a mother’s endometriosis phenotype. Those phenotypes include Isolated superficial peritoneal endometriosis, ovarian endometrioma, and deep endometriosis.

“Monitoring pregnancy beyond the normal protocols or changing management strategies may not be warranted in cases of endometriosis,” Dr. Marcellin said.

More research on endometriosis’ potential link to birth outcomes is needed.

An expert not involved with the study said the new paper highlights important new avenues of research but should not be seen as the final word on the connection between endometriosis and preterm birth.

Of the 1,351 study participants (mean age, 32.9 years) who had a singleton delivery after 22 weeks’ gestation, 470 were assigned to the endometriosis group, and 881 were assigned to the control group.

The authors concluded that “pregnant women with endometriosis should not be considered to have an exceptionally high risk for preterm birth. However, further studies are needed to examine the potential for other adverse perinatal outcomes or specific but rare complications.”

Daniela Carusi, MD, said the difficulty with the study’s design is that “premature birth is not one problem or one disease.”

Many very different problems can all end with premature birth. Sometimes it’s an infection or inflammation or bleeding in the uterus or hypertension in the mother, for example, and all those things can lead to a preterm birth, she explained.

“This study inherently lumps all those things together,” said Dr. Carusi, who is director of surgical obstetrics and placental abnormalities in the department of obstetrics and gynecology at Brigham and Women’s Hospital, Boston. “It’s quite possible endometriosis can have a big impact in one of those areas and no impact in the other areas, but the study design wouldn’t be able to pick that up.”
 

Editorialists: Results challenge findings of previous studies

In an accompanying commentary, Liisu Saavalainen, MD, PhD, and Oskari Heikinheimo, MD, PhD, both with the department of obstetrics and gynecology, Helsinki University Hospital, wrote that several previous studies have suggested that women with endometriosis have a slightly higher risk for preterm birth.

Those studies were mostly retrospective and differed in the way they classified endometriosis and the way they selected patients, the editorialists write. Also, most women in these studies typically had subfertility, they added.

The study by Dr. Marcellin and colleagues differs from previous related research in that was prospective and assessed the risk for preterm delivery in women both with endometriosis and those without endometriosis from several maternity centers in France. The women with endometriosis were classified according to the severity of their disease.

The editorialists wrote: “The novel results by Marcellin et al. challenge the findings of most previous studies on this topic. These results are valuable and comforting. However, they are also likely to trigger new studies on the pregnancy risks associated with different types of endometriosis. That is good news.”

Dr. Carusi said the study was well done and included a notably large size. Further complimenting the research, she said it’s important to talk about this little-discussed pregnancy complication. There’s been much more focus for women with endometriosis and their physicians on getting pregnant and on talking about the length of their term.

The study leaves some things unanswered.

The study was funded by research grants from the French Ministry of Health and was sponsored by the Département de la Recherche Clinique et du Développement de l’Assistance Publique–Hôpitaux de Paris. Dr. Carusi reported no relevant financial relationships. One study coauthor reported receiving personal fees from Bioserinity and Ferring outside the submitted work. No other disclosures were reported.

A version of this article first appeared on Medscape.com.

Researchers evaluating whether endometriosis is linked with preterm birth found no such association in a multicenter cohort study of more than 1300 women.

These new findings, which were published online in JAMA Network Open, suggest that changing monitoring strategies to prevent preterm birth for women with the disease may not be necessary.

The research team, led by Louis Marcellin, MD, PhD, with the department of obstetrics and gynecology at Université de Paris, also found that disease phenotype or whether the preterm birth was induced or spontaneous did not appear to alter the result.

Those results differ from previous research. Data on the phenotypes and their link with preterm birth have been scarce, but previous studies have shown the risk for preterm birth is more pronounced in women who have deep endometriosis than in women with ovarian endometriosis.

Dr. Marcellin said in an interview that “little is known about the impact of endometriosis on obstetric outcomes. In contrast to previous studies, we reported no differences in the risk for preterm delivery between women with endometriosis (34 of 470 [7.2%]) and those without endometriosis (53 of 881 [6.0%]), even when adjusted for multiple factors.”

The authors accounted for mother’s age, body mass index before pregnancy, birth country, number of times the woman had given birth, previous cesarean delivery, and history of preterm birth. After adjusting for potential confounders, endometriosis was not associated with preterm birth (adjusted odds ratio, 1.07; 95% confidence interval, 0.64-1.77).

The researchers found no differences among preterm births based on a mother’s endometriosis phenotype. Those phenotypes include Isolated superficial peritoneal endometriosis, ovarian endometrioma, and deep endometriosis.

“Monitoring pregnancy beyond the normal protocols or changing management strategies may not be warranted in cases of endometriosis,” Dr. Marcellin said.

More research on endometriosis’ potential link to birth outcomes is needed.

An expert not involved with the study said the new paper highlights important new avenues of research but should not be seen as the final word on the connection between endometriosis and preterm birth.

Of the 1,351 study participants (mean age, 32.9 years) who had a singleton delivery after 22 weeks’ gestation, 470 were assigned to the endometriosis group, and 881 were assigned to the control group.

The authors concluded that “pregnant women with endometriosis should not be considered to have an exceptionally high risk for preterm birth. However, further studies are needed to examine the potential for other adverse perinatal outcomes or specific but rare complications.”

Daniela Carusi, MD, said the difficulty with the study’s design is that “premature birth is not one problem or one disease.”

Many very different problems can all end with premature birth. Sometimes it’s an infection or inflammation or bleeding in the uterus or hypertension in the mother, for example, and all those things can lead to a preterm birth, she explained.

“This study inherently lumps all those things together,” said Dr. Carusi, who is director of surgical obstetrics and placental abnormalities in the department of obstetrics and gynecology at Brigham and Women’s Hospital, Boston. “It’s quite possible endometriosis can have a big impact in one of those areas and no impact in the other areas, but the study design wouldn’t be able to pick that up.”
 

Editorialists: Results challenge findings of previous studies

In an accompanying commentary, Liisu Saavalainen, MD, PhD, and Oskari Heikinheimo, MD, PhD, both with the department of obstetrics and gynecology, Helsinki University Hospital, wrote that several previous studies have suggested that women with endometriosis have a slightly higher risk for preterm birth.

Those studies were mostly retrospective and differed in the way they classified endometriosis and the way they selected patients, the editorialists write. Also, most women in these studies typically had subfertility, they added.

The study by Dr. Marcellin and colleagues differs from previous related research in that was prospective and assessed the risk for preterm delivery in women both with endometriosis and those without endometriosis from several maternity centers in France. The women with endometriosis were classified according to the severity of their disease.

The editorialists wrote: “The novel results by Marcellin et al. challenge the findings of most previous studies on this topic. These results are valuable and comforting. However, they are also likely to trigger new studies on the pregnancy risks associated with different types of endometriosis. That is good news.”

Dr. Carusi said the study was well done and included a notably large size. Further complimenting the research, she said it’s important to talk about this little-discussed pregnancy complication. There’s been much more focus for women with endometriosis and their physicians on getting pregnant and on talking about the length of their term.

The study leaves some things unanswered.

The study was funded by research grants from the French Ministry of Health and was sponsored by the Département de la Recherche Clinique et du Développement de l’Assistance Publique–Hôpitaux de Paris. Dr. Carusi reported no relevant financial relationships. One study coauthor reported receiving personal fees from Bioserinity and Ferring outside the submitted work. No other disclosures were reported.

A version of this article first appeared on Medscape.com.

Adolescents and young adults who use e-cigarettes reported vaping cannabis, according to selected data from the national Population Assessment of Tobacco and Health (PATH) study.

Ruoyan Sun, PhD, an assistant professor at the University of Alabama at Birmingham, and colleagues examined results of PATH’s wave5 survey conducted from December 2018 to November 2019. PATH is a National Institutes of Health–Food and Drug Administration collaboration begun in 2013.

Their analysis, published online Feb. 7, 2022, in JAMA Pediatrics, evaluated the frequency of cannabis vaping across several age groups: 164 respondents ages 12-14; 919 participants ages 15-17; and 3,038 participants ages 18-24. Respondents included for analysis reported electronic nicotine product consumption in the past 30 days. In response to the question “When you have used an electronic product, how often were you using it to smoke marijuana, marijuana concentrates, marijuana waxes, THC, or hash oils?” 35.0% (95% confidence interval, 29.3%-41.2%) of current e-smokers aged 12-14 years said they had done so, as did 51.3% (95% CI, 47.7%-54.9%) of those aged 15-17 years and 54.6% (95% CI, 52.5%-56.7%) of young adults aged 18-24.

The prevalence of those who reported vaping cannabis every time they vaped was 3.1% (95% CI, 1.3%-6.9%) of youths aged 12-14 years, 6.7% (95% CI, 5.3%-8.6%) of youths aged 15-17 years, and 10.3% (95% CI, 9.0%-11.6%) of young adults aged 18-24.

Among children ages 12-14, 65% said they never vaped cannabis, while 48.7% and 45.4%, respectively, in the two older groups said they did.

“This is a very important finding and it mirrors what some of us have already seen in practice,” said pediatric pulmonologist S. Christy Sadreameli, MD, MHS, an assistant professor of pediatrics at John Hopkins University, Baltimore. “It is important for pediatricians to realize that dual use of cannabis and nicotine vaping, and exclusive use of cannabis vaping, are not uncommon. It informs how we ask questions and how we counsel our patients.” Dr. Sadreameli was not involved in the PATH study.

Overall, the survey participants were 56% male, with 24% of respondents identifying as Hispanic, 8% as non-Hispanic Black, 58% as non-Hispanic White, and 10% as of other race/ethnicity. The weighted proportion of current e-cigarette use was 3.0% (95% CI, 2.6%-3.4%) in youths ages 12-14 years, 14.4% (95% CI, 13.5%-15.3%) in those 15-17 years, and 26.2% (95% CI, 25.3%-27.1%) in young adults.

Other recent national surveys such as the National Institute on Drug Abuses’s Monitoring the Future are reporting a growing prevalence of youth cannabis vaping, Dr. Sun said. For example, the prevalence of cannabis vaping in the past 12-month period among grade 12 students grew from 9.5% in 2017 to 22.1% in 2020. Vaping cannabis was more prevalent among Hispanic teens than other ethnicities.

Vaping devices such as e-cigarettes, vaping pens, e-cigars, and e-hookahs can be used to inhale multiple substances, including nicotine, cannabis, and opium, Dr. Sun noted in an interview. “So in addition to asking about the behavior of vaping itself, pediatricians could pay more attention to what is being vaped in these devices.”

According to Dr. Sadreameli, vaping more than one substance at a time could potentially work synergistically to cause more harm, compared with one product alone. “The other aspect to consider is that vaping multiple types of products may increase the chance of harm from other components of the mixture,” she said. For instance, a lot of the e-cigarette or vaping use-associated lung injury (EVALI) cases have been linked to vitamin E acetate, which was found in certain cannabis formulations. “Anecdotally, most EVALI patients I’ve met seemed to report use of multiple products, including cannabis-containing and nicotine-containing products.”

Dr. Sadreameli added that some cannabis vapers will have other issues. “For example, there is a severe vomiting syndrome I’ve seen, which is induced by cannabis and improved by cessation from cannabis,” she said. “It is important for pediatricians to ask the right questions of their patients in order to better understand what they may be experiencing, provide counseling, and to help them.”

A related issue is cessation, she said. “For those working to achieve cessation from nicotine-based products, sometimes nicotine replacement therapies are helpful. However, cessation from cannabis-containing products is going to look different.”

Although the study did not yield information on the prevalence simultaneous nicotine/cannabis vaping, the authors suggested that some vapers may be combining substances. Previous studies may have modestly overestimated the prevalence of nicotine vaping given their finding that some current e-cigarette users reported vaping cannabis every time they vaped and may be vaping cannabis exclusively. “However, if some current users vaped nicotine and cannabis simultaneously, then overestimation of nicotine vaping would be smaller,” they wrote.

Future surveys on this area should contain detailed questions on nicotine and cannabis vaping, including the substance being vaped and the frequency and intensity of use, Dr. Sun said. “In addition, these surveys could examine some other substances that are being vaped, such as opium and cocaine.”

The PATH study is supported by the NIH, National Institute on Drug Abuse, Department of Health & Human Services, and the FDA’s Center for Tobacco Products. The authors and Dr. Sadreameli had no competing interests to disclose.

Adolescents and young adults who use e-cigarettes reported vaping cannabis, according to selected data from the national Population Assessment of Tobacco and Health (PATH) study.

Ruoyan Sun, PhD, an assistant professor at the University of Alabama at Birmingham, and colleagues examined results of PATH’s wave5 survey conducted from December 2018 to November 2019. PATH is a National Institutes of Health–Food and Drug Administration collaboration begun in 2013.

Their analysis, published online Feb. 7, 2022, in JAMA Pediatrics, evaluated the frequency of cannabis vaping across several age groups: 164 respondents ages 12-14; 919 participants ages 15-17; and 3,038 participants ages 18-24. Respondents included for analysis reported electronic nicotine product consumption in the past 30 days. In response to the question “When you have used an electronic product, how often were you using it to smoke marijuana, marijuana concentrates, marijuana waxes, THC, or hash oils?” 35.0% (95% confidence interval, 29.3%-41.2%) of current e-smokers aged 12-14 years said they had done so, as did 51.3% (95% CI, 47.7%-54.9%) of those aged 15-17 years and 54.6% (95% CI, 52.5%-56.7%) of young adults aged 18-24.

The prevalence of those who reported vaping cannabis every time they vaped was 3.1% (95% CI, 1.3%-6.9%) of youths aged 12-14 years, 6.7% (95% CI, 5.3%-8.6%) of youths aged 15-17 years, and 10.3% (95% CI, 9.0%-11.6%) of young adults aged 18-24.

Among children ages 12-14, 65% said they never vaped cannabis, while 48.7% and 45.4%, respectively, in the two older groups said they did.

“This is a very important finding and it mirrors what some of us have already seen in practice,” said pediatric pulmonologist S. Christy Sadreameli, MD, MHS, an assistant professor of pediatrics at John Hopkins University, Baltimore. “It is important for pediatricians to realize that dual use of cannabis and nicotine vaping, and exclusive use of cannabis vaping, are not uncommon. It informs how we ask questions and how we counsel our patients.” Dr. Sadreameli was not involved in the PATH study.

Overall, the survey participants were 56% male, with 24% of respondents identifying as Hispanic, 8% as non-Hispanic Black, 58% as non-Hispanic White, and 10% as of other race/ethnicity. The weighted proportion of current e-cigarette use was 3.0% (95% CI, 2.6%-3.4%) in youths ages 12-14 years, 14.4% (95% CI, 13.5%-15.3%) in those 15-17 years, and 26.2% (95% CI, 25.3%-27.1%) in young adults.

Other recent national surveys such as the National Institute on Drug Abuses’s Monitoring the Future are reporting a growing prevalence of youth cannabis vaping, Dr. Sun said. For example, the prevalence of cannabis vaping in the past 12-month period among grade 12 students grew from 9.5% in 2017 to 22.1% in 2020. Vaping cannabis was more prevalent among Hispanic teens than other ethnicities.

Vaping devices such as e-cigarettes, vaping pens, e-cigars, and e-hookahs can be used to inhale multiple substances, including nicotine, cannabis, and opium, Dr. Sun noted in an interview. “So in addition to asking about the behavior of vaping itself, pediatricians could pay more attention to what is being vaped in these devices.”

According to Dr. Sadreameli, vaping more than one substance at a time could potentially work synergistically to cause more harm, compared with one product alone. “The other aspect to consider is that vaping multiple types of products may increase the chance of harm from other components of the mixture,” she said. For instance, a lot of the e-cigarette or vaping use-associated lung injury (EVALI) cases have been linked to vitamin E acetate, which was found in certain cannabis formulations. “Anecdotally, most EVALI patients I’ve met seemed to report use of multiple products, including cannabis-containing and nicotine-containing products.”

Dr. Sadreameli added that some cannabis vapers will have other issues. “For example, there is a severe vomiting syndrome I’ve seen, which is induced by cannabis and improved by cessation from cannabis,” she said. “It is important for pediatricians to ask the right questions of their patients in order to better understand what they may be experiencing, provide counseling, and to help them.”

A related issue is cessation, she said. “For those working to achieve cessation from nicotine-based products, sometimes nicotine replacement therapies are helpful. However, cessation from cannabis-containing products is going to look different.”

Although the study did not yield information on the prevalence simultaneous nicotine/cannabis vaping, the authors suggested that some vapers may be combining substances. Previous studies may have modestly overestimated the prevalence of nicotine vaping given their finding that some current e-cigarette users reported vaping cannabis every time they vaped and may be vaping cannabis exclusively. “However, if some current users vaped nicotine and cannabis simultaneously, then overestimation of nicotine vaping would be smaller,” they wrote.

Future surveys on this area should contain detailed questions on nicotine and cannabis vaping, including the substance being vaped and the frequency and intensity of use, Dr. Sun said. “In addition, these surveys could examine some other substances that are being vaped, such as opium and cocaine.”

The PATH study is supported by the NIH, National Institute on Drug Abuse, Department of Health & Human Services, and the FDA’s Center for Tobacco Products. The authors and Dr. Sadreameli had no competing interests to disclose.

Adolescents and young adults who use e-cigarettes reported vaping cannabis, according to selected data from the national Population Assessment of Tobacco and Health (PATH) study.

Ruoyan Sun, PhD, an assistant professor at the University of Alabama at Birmingham, and colleagues examined results of PATH’s wave5 survey conducted from December 2018 to November 2019. PATH is a National Institutes of Health–Food and Drug Administration collaboration begun in 2013.

Their analysis, published online Feb. 7, 2022, in JAMA Pediatrics, evaluated the frequency of cannabis vaping across several age groups: 164 respondents ages 12-14; 919 participants ages 15-17; and 3,038 participants ages 18-24. Respondents included for analysis reported electronic nicotine product consumption in the past 30 days. In response to the question “When you have used an electronic product, how often were you using it to smoke marijuana, marijuana concentrates, marijuana waxes, THC, or hash oils?” 35.0% (95% confidence interval, 29.3%-41.2%) of current e-smokers aged 12-14 years said they had done so, as did 51.3% (95% CI, 47.7%-54.9%) of those aged 15-17 years and 54.6% (95% CI, 52.5%-56.7%) of young adults aged 18-24.

The prevalence of those who reported vaping cannabis every time they vaped was 3.1% (95% CI, 1.3%-6.9%) of youths aged 12-14 years, 6.7% (95% CI, 5.3%-8.6%) of youths aged 15-17 years, and 10.3% (95% CI, 9.0%-11.6%) of young adults aged 18-24.

Among children ages 12-14, 65% said they never vaped cannabis, while 48.7% and 45.4%, respectively, in the two older groups said they did.

“This is a very important finding and it mirrors what some of us have already seen in practice,” said pediatric pulmonologist S. Christy Sadreameli, MD, MHS, an assistant professor of pediatrics at John Hopkins University, Baltimore. “It is important for pediatricians to realize that dual use of cannabis and nicotine vaping, and exclusive use of cannabis vaping, are not uncommon. It informs how we ask questions and how we counsel our patients.” Dr. Sadreameli was not involved in the PATH study.

Overall, the survey participants were 56% male, with 24% of respondents identifying as Hispanic, 8% as non-Hispanic Black, 58% as non-Hispanic White, and 10% as of other race/ethnicity. The weighted proportion of current e-cigarette use was 3.0% (95% CI, 2.6%-3.4%) in youths ages 12-14 years, 14.4% (95% CI, 13.5%-15.3%) in those 15-17 years, and 26.2% (95% CI, 25.3%-27.1%) in young adults.

Other recent national surveys such as the National Institute on Drug Abuses’s Monitoring the Future are reporting a growing prevalence of youth cannabis vaping, Dr. Sun said. For example, the prevalence of cannabis vaping in the past 12-month period among grade 12 students grew from 9.5% in 2017 to 22.1% in 2020. Vaping cannabis was more prevalent among Hispanic teens than other ethnicities.

Vaping devices such as e-cigarettes, vaping pens, e-cigars, and e-hookahs can be used to inhale multiple substances, including nicotine, cannabis, and opium, Dr. Sun noted in an interview. “So in addition to asking about the behavior of vaping itself, pediatricians could pay more attention to what is being vaped in these devices.”

According to Dr. Sadreameli, vaping more than one substance at a time could potentially work synergistically to cause more harm, compared with one product alone. “The other aspect to consider is that vaping multiple types of products may increase the chance of harm from other components of the mixture,” she said. For instance, a lot of the e-cigarette or vaping use-associated lung injury (EVALI) cases have been linked to vitamin E acetate, which was found in certain cannabis formulations. “Anecdotally, most EVALI patients I’ve met seemed to report use of multiple products, including cannabis-containing and nicotine-containing products.”

Dr. Sadreameli added that some cannabis vapers will have other issues. “For example, there is a severe vomiting syndrome I’ve seen, which is induced by cannabis and improved by cessation from cannabis,” she said. “It is important for pediatricians to ask the right questions of their patients in order to better understand what they may be experiencing, provide counseling, and to help them.”

A related issue is cessation, she said. “For those working to achieve cessation from nicotine-based products, sometimes nicotine replacement therapies are helpful. However, cessation from cannabis-containing products is going to look different.”

Although the study did not yield information on the prevalence simultaneous nicotine/cannabis vaping, the authors suggested that some vapers may be combining substances. Previous studies may have modestly overestimated the prevalence of nicotine vaping given their finding that some current e-cigarette users reported vaping cannabis every time they vaped and may be vaping cannabis exclusively. “However, if some current users vaped nicotine and cannabis simultaneously, then overestimation of nicotine vaping would be smaller,” they wrote.

Future surveys on this area should contain detailed questions on nicotine and cannabis vaping, including the substance being vaped and the frequency and intensity of use, Dr. Sun said. “In addition, these surveys could examine some other substances that are being vaped, such as opium and cocaine.”

The PATH study is supported by the NIH, National Institute on Drug Abuse, Department of Health & Human Services, and the FDA’s Center for Tobacco Products. The authors and Dr. Sadreameli had no competing interests to disclose.

When children with atopic dermatitis (AD) present to the clinic and their parents complain that no previously recommended medical therapies have worked, what’s the next step?

“Many patients who have failed topical steroids have never had adequate treatment,” Anna Yasmine Kirkorian, MD, chief of dermatology at National Children’s Hospital in Washington, said during the ODAC Dermatology, Aesthetic & Surgical Conference. “There is no lower age limit on the use of topical corticosteroids, and low potency corticosteroids are inadequate to treat severe eczema. The idea that only over-the-counter 2.5% hydrocortisone cream is necessary is not true,” she added.

“You also want to scrutinize the vehicle,” she said, noting that children are often prescribed cream formulations that hurt when applied, so parents stop applying them. “Ointments are generally the vehicles of choice in childhood,” she added.

It is generally not advised to use topical and oral antibiotics in children with AD, unless there are clear signs of infection. “If they’re just slightly oozy, don’t use them,” she continued. “Of course, every child or adult with eczema has Staph aureus on them, but most of the time, what you need to do is repair the barrier. We know that from data and common sense. When we repair their barrier, their rates of infection decrease.”

A focal area with pustules and pus should be cultured and treated, Dr. Kirkorian said. “Monotherapy with antibiotics is going to do nothing for you.” In cases of children with failure to thrive, she recommends referral to pediatric dermatology, allergy/immunology, GI, or genetics, as appropriate.

For children with severe AD, Dr. Kirkorian favors a rescue plan with a one-pound jar of triamcinolone ointment 0.1%. She recommends application of the ointment to all areas, including the face and scalp once nightly for 2 weeks, with a follow-up appointment at the end of that time. “If you just give people medicine and ask them to come back in 6 months, they are not able to comply with that and they don’t have faith that it’s going to work,” explained Dr. Kirkorian, associate professor of dermatology and pediatrics at George Washington University, Washington. At the end of 2 weeks, “the majority will have improved dramatically, and then you can implement maintenance therapy with topical calcineurin inhibitors, crisaborole, or possibly topical ruxolitinib.”

Some clinicians prescribe oral antihistamines for AD, but Dr. Kirkorian said that data supporting their use are limited and antihistamines are not approved for use in children younger than 6 months of age. Sedating antihistamines will induce sleep, “but do not provide durable night-long sleep,” and routine use may have an impact on learning and school performance. In addition, exposure to antihistamines in children under age 2 may be associated with development of ADHD at school age.

The interleukin-4 receptor alpha antagonist dupilumab (Dupixent) is approved by the Food and Drug Administration for moderate to severe AD in patients ages 6 and older. But obtaining it for patients can be tricky, she said, as this requires documented failure of corticosteroids, calcineurin inhibitors, crisaborole ointment, and phototherapy (if prescribed). Patients are often obligated to do step therapy with an off-label drug such as cyclosporine or methotrexate for 3 months, and they need to demonstrate responses with objective measures of severity such as the SCORAD (SCORing Atopic Dermatitis) and the validated Investigator Global Assessment.

“Most of my patients carry insurance that does not approve dupilumab without failure of a prior off-label systemic immunosuppressant medication,” Dr. Kirkorian said. Cyclosporine is her first choice for a systemic immunosuppressant “because it has a fast onset of action, it’s effective for treatment of atopic dermatitis, and safe for short-term use,” she said. “I don’t think that methotrexate works well for eczema. It can take weeks and weeks to work.”

She typically starts patients on a 5 mg/kg dose of cyclosporine. Baseline tests include CBC, CMP (comprehensive metabolic panel), lipids, and vitals. She repeats the labs at 1 month, and includes a blood pressure check. Potential adverse effects of cyclosporine include infections (including opportunistic infections), cytopenias, hypertension, nephrotoxicity, hepatotoxicity, neurotoxicity (including posterior reversible encephalopathy syndrome), electrolyte disturbance, lymphoma, and cutaneous malignancy.

“The good news is that we generally don’t see the adverse effects with short-term use,” Dr. Kirkorian said. “We will see some hypertrichosis and gingival hypertrophy, which resolves with cessation of therapy. There are serious side effects if you use it for long enough.”

As for methotrexate, “it is still a very important drug in pediatric dermatology, particularly in other conditions such as psoriasis,” she said. “The problem is that weekly dosing of methotrexate poses a greater risk of dosing errors. People aren’t really triggered to think of a once-weekly medication. If you do use it, give them a short supply to make sure that they come back, and that they don’t give it daily accidentally.”

Practical tips she offered for prescribing cyclosporine include supplying a patient handout with information on all adverse effects, dosing information, vaccination information, and pregnancy precautions, with contact information (a patient portal or on-call number) for the treating clinician in case a patient develops adverse effects. Administration of live vaccines while patients are on cyclosporine is not recommended.

When transitioning patients from cyclosporine or methotrexate to dupilumab, Dr. Kirkorian recommends tapering the immunosuppressant dose by half every 2 weeks to complete cessation by week 8 of treatment. For patients who experience a severe baseline flare once the immunosuppressant is tapered, despite the switch to dupilumab, she recommends restarting methotrexate at a full dose and then reducing the dose every 2 weeks until the lowest effective dose (2.5-5 mg weekly) is reached.

“Waning efficacy is real,” she said. “We can add methotrexate to recapture efficacy. Check for superimposed allergic contact dermatitis.”

With upadacitinib (Rinvoq), an oral Janus kinase (JAK) inhibitor recently approved for treating refractory, moderate to severe AD in patients 12 years of age and older, is the risk profile acceptable to parents and physicians? “I think the answer is yes,” Dr. Kirkorian said. “But we’re going to have to think through that very carefully. It’s going to be exciting to see how this drug changes management in our patients.”

Dr. Kirkorian disclosed that she is a member of the advisory board for Verrica Pharmaceuticals.

When children with atopic dermatitis (AD) present to the clinic and their parents complain that no previously recommended medical therapies have worked, what’s the next step?

“Many patients who have failed topical steroids have never had adequate treatment,” Anna Yasmine Kirkorian, MD, chief of dermatology at National Children’s Hospital in Washington, said during the ODAC Dermatology, Aesthetic & Surgical Conference. “There is no lower age limit on the use of topical corticosteroids, and low potency corticosteroids are inadequate to treat severe eczema. The idea that only over-the-counter 2.5% hydrocortisone cream is necessary is not true,” she added.

“You also want to scrutinize the vehicle,” she said, noting that children are often prescribed cream formulations that hurt when applied, so parents stop applying them. “Ointments are generally the vehicles of choice in childhood,” she added.

It is generally not advised to use topical and oral antibiotics in children with AD, unless there are clear signs of infection. “If they’re just slightly oozy, don’t use them,” she continued. “Of course, every child or adult with eczema has Staph aureus on them, but most of the time, what you need to do is repair the barrier. We know that from data and common sense. When we repair their barrier, their rates of infection decrease.”

A focal area with pustules and pus should be cultured and treated, Dr. Kirkorian said. “Monotherapy with antibiotics is going to do nothing for you.” In cases of children with failure to thrive, she recommends referral to pediatric dermatology, allergy/immunology, GI, or genetics, as appropriate.

For children with severe AD, Dr. Kirkorian favors a rescue plan with a one-pound jar of triamcinolone ointment 0.1%. She recommends application of the ointment to all areas, including the face and scalp once nightly for 2 weeks, with a follow-up appointment at the end of that time. “If you just give people medicine and ask them to come back in 6 months, they are not able to comply with that and they don’t have faith that it’s going to work,” explained Dr. Kirkorian, associate professor of dermatology and pediatrics at George Washington University, Washington. At the end of 2 weeks, “the majority will have improved dramatically, and then you can implement maintenance therapy with topical calcineurin inhibitors, crisaborole, or possibly topical ruxolitinib.”

Some clinicians prescribe oral antihistamines for AD, but Dr. Kirkorian said that data supporting their use are limited and antihistamines are not approved for use in children younger than 6 months of age. Sedating antihistamines will induce sleep, “but do not provide durable night-long sleep,” and routine use may have an impact on learning and school performance. In addition, exposure to antihistamines in children under age 2 may be associated with development of ADHD at school age.

The interleukin-4 receptor alpha antagonist dupilumab (Dupixent) is approved by the Food and Drug Administration for moderate to severe AD in patients ages 6 and older. But obtaining it for patients can be tricky, she said, as this requires documented failure of corticosteroids, calcineurin inhibitors, crisaborole ointment, and phototherapy (if prescribed). Patients are often obligated to do step therapy with an off-label drug such as cyclosporine or methotrexate for 3 months, and they need to demonstrate responses with objective measures of severity such as the SCORAD (SCORing Atopic Dermatitis) and the validated Investigator Global Assessment.

“Most of my patients carry insurance that does not approve dupilumab without failure of a prior off-label systemic immunosuppressant medication,” Dr. Kirkorian said. Cyclosporine is her first choice for a systemic immunosuppressant “because it has a fast onset of action, it’s effective for treatment of atopic dermatitis, and safe for short-term use,” she said. “I don’t think that methotrexate works well for eczema. It can take weeks and weeks to work.”

She typically starts patients on a 5 mg/kg dose of cyclosporine. Baseline tests include CBC, CMP (comprehensive metabolic panel), lipids, and vitals. She repeats the labs at 1 month, and includes a blood pressure check. Potential adverse effects of cyclosporine include infections (including opportunistic infections), cytopenias, hypertension, nephrotoxicity, hepatotoxicity, neurotoxicity (including posterior reversible encephalopathy syndrome), electrolyte disturbance, lymphoma, and cutaneous malignancy.

“The good news is that we generally don’t see the adverse effects with short-term use,” Dr. Kirkorian said. “We will see some hypertrichosis and gingival hypertrophy, which resolves with cessation of therapy. There are serious side effects if you use it for long enough.”

As for methotrexate, “it is still a very important drug in pediatric dermatology, particularly in other conditions such as psoriasis,” she said. “The problem is that weekly dosing of methotrexate poses a greater risk of dosing errors. People aren’t really triggered to think of a once-weekly medication. If you do use it, give them a short supply to make sure that they come back, and that they don’t give it daily accidentally.”

Practical tips she offered for prescribing cyclosporine include supplying a patient handout with information on all adverse effects, dosing information, vaccination information, and pregnancy precautions, with contact information (a patient portal or on-call number) for the treating clinician in case a patient develops adverse effects. Administration of live vaccines while patients are on cyclosporine is not recommended.

When transitioning patients from cyclosporine or methotrexate to dupilumab, Dr. Kirkorian recommends tapering the immunosuppressant dose by half every 2 weeks to complete cessation by week 8 of treatment. For patients who experience a severe baseline flare once the immunosuppressant is tapered, despite the switch to dupilumab, she recommends restarting methotrexate at a full dose and then reducing the dose every 2 weeks until the lowest effective dose (2.5-5 mg weekly) is reached.

“Waning efficacy is real,” she said. “We can add methotrexate to recapture efficacy. Check for superimposed allergic contact dermatitis.”

With upadacitinib (Rinvoq), an oral Janus kinase (JAK) inhibitor recently approved for treating refractory, moderate to severe AD in patients 12 years of age and older, is the risk profile acceptable to parents and physicians? “I think the answer is yes,” Dr. Kirkorian said. “But we’re going to have to think through that very carefully. It’s going to be exciting to see how this drug changes management in our patients.”

Dr. Kirkorian disclosed that she is a member of the advisory board for Verrica Pharmaceuticals.

When children with atopic dermatitis (AD) present to the clinic and their parents complain that no previously recommended medical therapies have worked, what’s the next step?

“Many patients who have failed topical steroids have never had adequate treatment,” Anna Yasmine Kirkorian, MD, chief of dermatology at National Children’s Hospital in Washington, said during the ODAC Dermatology, Aesthetic & Surgical Conference. “There is no lower age limit on the use of topical corticosteroids, and low potency corticosteroids are inadequate to treat severe eczema. The idea that only over-the-counter 2.5% hydrocortisone cream is necessary is not true,” she added.

“You also want to scrutinize the vehicle,” she said, noting that children are often prescribed cream formulations that hurt when applied, so parents stop applying them. “Ointments are generally the vehicles of choice in childhood,” she added.

It is generally not advised to use topical and oral antibiotics in children with AD, unless there are clear signs of infection. “If they’re just slightly oozy, don’t use them,” she continued. “Of course, every child or adult with eczema has Staph aureus on them, but most of the time, what you need to do is repair the barrier. We know that from data and common sense. When we repair their barrier, their rates of infection decrease.”

A focal area with pustules and pus should be cultured and treated, Dr. Kirkorian said. “Monotherapy with antibiotics is going to do nothing for you.” In cases of children with failure to thrive, she recommends referral to pediatric dermatology, allergy/immunology, GI, or genetics, as appropriate.

For children with severe AD, Dr. Kirkorian favors a rescue plan with a one-pound jar of triamcinolone ointment 0.1%. She recommends application of the ointment to all areas, including the face and scalp once nightly for 2 weeks, with a follow-up appointment at the end of that time. “If you just give people medicine and ask them to come back in 6 months, they are not able to comply with that and they don’t have faith that it’s going to work,” explained Dr. Kirkorian, associate professor of dermatology and pediatrics at George Washington University, Washington. At the end of 2 weeks, “the majority will have improved dramatically, and then you can implement maintenance therapy with topical calcineurin inhibitors, crisaborole, or possibly topical ruxolitinib.”

Some clinicians prescribe oral antihistamines for AD, but Dr. Kirkorian said that data supporting their use are limited and antihistamines are not approved for use in children younger than 6 months of age. Sedating antihistamines will induce sleep, “but do not provide durable night-long sleep,” and routine use may have an impact on learning and school performance. In addition, exposure to antihistamines in children under age 2 may be associated with development of ADHD at school age.

The interleukin-4 receptor alpha antagonist dupilumab (Dupixent) is approved by the Food and Drug Administration for moderate to severe AD in patients ages 6 and older. But obtaining it for patients can be tricky, she said, as this requires documented failure of corticosteroids, calcineurin inhibitors, crisaborole ointment, and phototherapy (if prescribed). Patients are often obligated to do step therapy with an off-label drug such as cyclosporine or methotrexate for 3 months, and they need to demonstrate responses with objective measures of severity such as the SCORAD (SCORing Atopic Dermatitis) and the validated Investigator Global Assessment.

“Most of my patients carry insurance that does not approve dupilumab without failure of a prior off-label systemic immunosuppressant medication,” Dr. Kirkorian said. Cyclosporine is her first choice for a systemic immunosuppressant “because it has a fast onset of action, it’s effective for treatment of atopic dermatitis, and safe for short-term use,” she said. “I don’t think that methotrexate works well for eczema. It can take weeks and weeks to work.”

She typically starts patients on a 5 mg/kg dose of cyclosporine. Baseline tests include CBC, CMP (comprehensive metabolic panel), lipids, and vitals. She repeats the labs at 1 month, and includes a blood pressure check. Potential adverse effects of cyclosporine include infections (including opportunistic infections), cytopenias, hypertension, nephrotoxicity, hepatotoxicity, neurotoxicity (including posterior reversible encephalopathy syndrome), electrolyte disturbance, lymphoma, and cutaneous malignancy.

“The good news is that we generally don’t see the adverse effects with short-term use,” Dr. Kirkorian said. “We will see some hypertrichosis and gingival hypertrophy, which resolves with cessation of therapy. There are serious side effects if you use it for long enough.”

As for methotrexate, “it is still a very important drug in pediatric dermatology, particularly in other conditions such as psoriasis,” she said. “The problem is that weekly dosing of methotrexate poses a greater risk of dosing errors. People aren’t really triggered to think of a once-weekly medication. If you do use it, give them a short supply to make sure that they come back, and that they don’t give it daily accidentally.”

Practical tips she offered for prescribing cyclosporine include supplying a patient handout with information on all adverse effects, dosing information, vaccination information, and pregnancy precautions, with contact information (a patient portal or on-call number) for the treating clinician in case a patient develops adverse effects. Administration of live vaccines while patients are on cyclosporine is not recommended.

When transitioning patients from cyclosporine or methotrexate to dupilumab, Dr. Kirkorian recommends tapering the immunosuppressant dose by half every 2 weeks to complete cessation by week 8 of treatment. For patients who experience a severe baseline flare once the immunosuppressant is tapered, despite the switch to dupilumab, she recommends restarting methotrexate at a full dose and then reducing the dose every 2 weeks until the lowest effective dose (2.5-5 mg weekly) is reached.

“Waning efficacy is real,” she said. “We can add methotrexate to recapture efficacy. Check for superimposed allergic contact dermatitis.”

With upadacitinib (Rinvoq), an oral Janus kinase (JAK) inhibitor recently approved for treating refractory, moderate to severe AD in patients 12 years of age and older, is the risk profile acceptable to parents and physicians? “I think the answer is yes,” Dr. Kirkorian said. “But we’re going to have to think through that very carefully. It’s going to be exciting to see how this drug changes management in our patients.”

Dr. Kirkorian disclosed that she is a member of the advisory board for Verrica Pharmaceuticals.

Long COVID can affect adults, young people, and children, and now for the first time, in a landmark study accepted for publication in the Archives of Disease in Childhood, formal agreement has been made on a research definition for post–acute COVID-19, or “long COVID” as it is commonly known, in children and young people.

The researchers charged themselves with a single objective – to derive a research definition for long COVID (post–acute COVID-19) in children and young people to allow comparisons between research studies. Specifically, so studies on prevalence, course, and outcome of long COVID in this age group can be reliably compared, because to date there has been no consensus. In fact, the authors pointed out how the “slew of definitions” currently used all differ in number, type, and duration of symptoms, which hampers research efforts. In addition, the lack of definition consensus has contributed to very wide reported variations in the estimated prevalence of long COVID in children of 1%-51%, with the authors saying that a “consistently applied definition of long COVID will help reduce the variability of prevalence estimates.”
 

Statements sequentially whittled down

“Using robust consensus methodology,” the authors said, “we derived a research definition for long COVID in children and young people.”

To achieve the definition consensus, a three-phase online Delphi process was used, followed by a virtual consensus meeting. The 123 participants registered to take part in the study included 23 people (19%) in a lived experience panel, 50 (42%) in the researcher or researcher/service delivery combined panel and 47 (39%) in the service delivery panel. Of 120 registered participants, 105 (88%) completed phase 1, 86 eligible participants (82% of those completing phase 1) completed phase 2 and 77 eligible participants (90% of those completing phase 2) completed phase 3. Seventeen participants attended and voted at the consensus meeting – 4 (23%) from the service delivery panel, 11 (65%) from the researcher panel, and 2 (12%) from the lived experience panel.

Presented with 49 statements in each phase, participants scored these from 1-9 based on how important they were perceived to be with regards inclusion in the research definition of long COVID in children and young people. Having been sequentially whittled down in three phases, 10 statements were discussed at the consensus meeting, and a panel of eight 11- to 17-year-olds affected by long COVID also reviewed the statements to reach a final agreement.

Five of the statements were agreed to be included in the definition, which stated that long COVID in children and young people is a condition in which a child or young person has symptoms (at least one of which is a physical symptom) that have continued or developed after a diagnosis of COVID-19 (confirmed with one or more positive COVID tests); impact their physical, mental, or social well-being; are interfering with some aspect of daily living (for example, school, work, home, or relationships); and persist for a minimum duration of 12 weeks after initial testing for COVID-19 (even if symptoms have waxed and waned over that period).

David Strain, MBChB, MD, chair of the BMA board of science and clinical senior lecturer and honorary consultant, University of Exeter (England), told the Science Media Centre: “A Delphi study builds a consensus from the world’s experts by presenting a series of statements and continuing to refine them until there is agreement as to what the definition of pediatric long COVID should be.” He added: “This is vitally important in order to align the global research effort into long COVID.”
 

Reassuringly similar

From the agreed five statements, a further research definition was proposed to align with the World Health Organization definition for adults: “Post–COVID-19 condition occurs in young people with a history of confirmed SARS CoV-2 infection, with at least one persisting physical symptom for a minimum duration of 12 weeks after initial testing that cannot be explained by an alternative diagnosis. The symptoms have an impact on everyday functioning, may continue or develop after COVID-19 infection, and may fluctuate or relapse over time.”

The authors concluded: “This is the first research definition of long COVID (post–COVID-19 condition) in children and young people and complements the clinical case definition in adults proposed by WHO,” adding that the two definitions are “reassuringly similar.”

They reiterated how widespread adoption of this definition would allow comparisons between studies such that a core outcome set can be developed and the prevalence, course and outcome of long COVID in children and young people can be reliably evaluated, which “will substantially help strengthen the evidence base on this debilitating condition.”

In addition, the authors said that a consistently applied definition of long COVID will help to provide a “more accurate picture on the true impact of the condition.”

The researchers emphasized the need to differentiate between a clinical case definition and a research definition of long COVID and explained: “It is understandable that the patient groups representing people with long COVID are concerned about a definition that could restrict access to services that are needed.”

They went on to say that in their view the decision whether a child or young person can see a health care professional, access any support needed, or be referred, investigated, or treated for long COVID should be a “shared decision involving the young person, their carers, and clinicians.”

Dr. Strain reinforced that it was important that the definition was a research one and not a clinical one, pointing out that the 12-week period in the research definition “does not necessarily mean that a child or young person should need to wait 3 months before being offered help or assistance from their health care team, indeed a 3-month delay in offering support to a child or young person, at this vitally important period of their educational development, could have lasting long-term impacts.”

A version of this article first appeared on Medscape.co.uk.

Long COVID can affect adults, young people, and children, and now for the first time, in a landmark study accepted for publication in the Archives of Disease in Childhood, formal agreement has been made on a research definition for post–acute COVID-19, or “long COVID” as it is commonly known, in children and young people.

The researchers charged themselves with a single objective – to derive a research definition for long COVID (post–acute COVID-19) in children and young people to allow comparisons between research studies. Specifically, so studies on prevalence, course, and outcome of long COVID in this age group can be reliably compared, because to date there has been no consensus. In fact, the authors pointed out how the “slew of definitions” currently used all differ in number, type, and duration of symptoms, which hampers research efforts. In addition, the lack of definition consensus has contributed to very wide reported variations in the estimated prevalence of long COVID in children of 1%-51%, with the authors saying that a “consistently applied definition of long COVID will help reduce the variability of prevalence estimates.”
 

Statements sequentially whittled down

“Using robust consensus methodology,” the authors said, “we derived a research definition for long COVID in children and young people.”

To achieve the definition consensus, a three-phase online Delphi process was used, followed by a virtual consensus meeting. The 123 participants registered to take part in the study included 23 people (19%) in a lived experience panel, 50 (42%) in the researcher or researcher/service delivery combined panel and 47 (39%) in the service delivery panel. Of 120 registered participants, 105 (88%) completed phase 1, 86 eligible participants (82% of those completing phase 1) completed phase 2 and 77 eligible participants (90% of those completing phase 2) completed phase 3. Seventeen participants attended and voted at the consensus meeting – 4 (23%) from the service delivery panel, 11 (65%) from the researcher panel, and 2 (12%) from the lived experience panel.

Presented with 49 statements in each phase, participants scored these from 1-9 based on how important they were perceived to be with regards inclusion in the research definition of long COVID in children and young people. Having been sequentially whittled down in three phases, 10 statements were discussed at the consensus meeting, and a panel of eight 11- to 17-year-olds affected by long COVID also reviewed the statements to reach a final agreement.

Five of the statements were agreed to be included in the definition, which stated that long COVID in children and young people is a condition in which a child or young person has symptoms (at least one of which is a physical symptom) that have continued or developed after a diagnosis of COVID-19 (confirmed with one or more positive COVID tests); impact their physical, mental, or social well-being; are interfering with some aspect of daily living (for example, school, work, home, or relationships); and persist for a minimum duration of 12 weeks after initial testing for COVID-19 (even if symptoms have waxed and waned over that period).

David Strain, MBChB, MD, chair of the BMA board of science and clinical senior lecturer and honorary consultant, University of Exeter (England), told the Science Media Centre: “A Delphi study builds a consensus from the world’s experts by presenting a series of statements and continuing to refine them until there is agreement as to what the definition of pediatric long COVID should be.” He added: “This is vitally important in order to align the global research effort into long COVID.”
 

Reassuringly similar

From the agreed five statements, a further research definition was proposed to align with the World Health Organization definition for adults: “Post–COVID-19 condition occurs in young people with a history of confirmed SARS CoV-2 infection, with at least one persisting physical symptom for a minimum duration of 12 weeks after initial testing that cannot be explained by an alternative diagnosis. The symptoms have an impact on everyday functioning, may continue or develop after COVID-19 infection, and may fluctuate or relapse over time.”

The authors concluded: “This is the first research definition of long COVID (post–COVID-19 condition) in children and young people and complements the clinical case definition in adults proposed by WHO,” adding that the two definitions are “reassuringly similar.”

They reiterated how widespread adoption of this definition would allow comparisons between studies such that a core outcome set can be developed and the prevalence, course and outcome of long COVID in children and young people can be reliably evaluated, which “will substantially help strengthen the evidence base on this debilitating condition.”

In addition, the authors said that a consistently applied definition of long COVID will help to provide a “more accurate picture on the true impact of the condition.”

The researchers emphasized the need to differentiate between a clinical case definition and a research definition of long COVID and explained: “It is understandable that the patient groups representing people with long COVID are concerned about a definition that could restrict access to services that are needed.”

They went on to say that in their view the decision whether a child or young person can see a health care professional, access any support needed, or be referred, investigated, or treated for long COVID should be a “shared decision involving the young person, their carers, and clinicians.”

Dr. Strain reinforced that it was important that the definition was a research one and not a clinical one, pointing out that the 12-week period in the research definition “does not necessarily mean that a child or young person should need to wait 3 months before being offered help or assistance from their health care team, indeed a 3-month delay in offering support to a child or young person, at this vitally important period of their educational development, could have lasting long-term impacts.”

A version of this article first appeared on Medscape.co.uk.

Long COVID can affect adults, young people, and children, and now for the first time, in a landmark study accepted for publication in the Archives of Disease in Childhood, formal agreement has been made on a research definition for post–acute COVID-19, or “long COVID” as it is commonly known, in children and young people.

The researchers charged themselves with a single objective – to derive a research definition for long COVID (post–acute COVID-19) in children and young people to allow comparisons between research studies. Specifically, so studies on prevalence, course, and outcome of long COVID in this age group can be reliably compared, because to date there has been no consensus. In fact, the authors pointed out how the “slew of definitions” currently used all differ in number, type, and duration of symptoms, which hampers research efforts. In addition, the lack of definition consensus has contributed to very wide reported variations in the estimated prevalence of long COVID in children of 1%-51%, with the authors saying that a “consistently applied definition of long COVID will help reduce the variability of prevalence estimates.”
 

Statements sequentially whittled down

“Using robust consensus methodology,” the authors said, “we derived a research definition for long COVID in children and young people.”

To achieve the definition consensus, a three-phase online Delphi process was used, followed by a virtual consensus meeting. The 123 participants registered to take part in the study included 23 people (19%) in a lived experience panel, 50 (42%) in the researcher or researcher/service delivery combined panel and 47 (39%) in the service delivery panel. Of 120 registered participants, 105 (88%) completed phase 1, 86 eligible participants (82% of those completing phase 1) completed phase 2 and 77 eligible participants (90% of those completing phase 2) completed phase 3. Seventeen participants attended and voted at the consensus meeting – 4 (23%) from the service delivery panel, 11 (65%) from the researcher panel, and 2 (12%) from the lived experience panel.

Presented with 49 statements in each phase, participants scored these from 1-9 based on how important they were perceived to be with regards inclusion in the research definition of long COVID in children and young people. Having been sequentially whittled down in three phases, 10 statements were discussed at the consensus meeting, and a panel of eight 11- to 17-year-olds affected by long COVID also reviewed the statements to reach a final agreement.

Five of the statements were agreed to be included in the definition, which stated that long COVID in children and young people is a condition in which a child or young person has symptoms (at least one of which is a physical symptom) that have continued or developed after a diagnosis of COVID-19 (confirmed with one or more positive COVID tests); impact their physical, mental, or social well-being; are interfering with some aspect of daily living (for example, school, work, home, or relationships); and persist for a minimum duration of 12 weeks after initial testing for COVID-19 (even if symptoms have waxed and waned over that period).

David Strain, MBChB, MD, chair of the BMA board of science and clinical senior lecturer and honorary consultant, University of Exeter (England), told the Science Media Centre: “A Delphi study builds a consensus from the world’s experts by presenting a series of statements and continuing to refine them until there is agreement as to what the definition of pediatric long COVID should be.” He added: “This is vitally important in order to align the global research effort into long COVID.”
 

Reassuringly similar

From the agreed five statements, a further research definition was proposed to align with the World Health Organization definition for adults: “Post–COVID-19 condition occurs in young people with a history of confirmed SARS CoV-2 infection, with at least one persisting physical symptom for a minimum duration of 12 weeks after initial testing that cannot be explained by an alternative diagnosis. The symptoms have an impact on everyday functioning, may continue or develop after COVID-19 infection, and may fluctuate or relapse over time.”

The authors concluded: “This is the first research definition of long COVID (post–COVID-19 condition) in children and young people and complements the clinical case definition in adults proposed by WHO,” adding that the two definitions are “reassuringly similar.”

They reiterated how widespread adoption of this definition would allow comparisons between studies such that a core outcome set can be developed and the prevalence, course and outcome of long COVID in children and young people can be reliably evaluated, which “will substantially help strengthen the evidence base on this debilitating condition.”

In addition, the authors said that a consistently applied definition of long COVID will help to provide a “more accurate picture on the true impact of the condition.”

The researchers emphasized the need to differentiate between a clinical case definition and a research definition of long COVID and explained: “It is understandable that the patient groups representing people with long COVID are concerned about a definition that could restrict access to services that are needed.”

They went on to say that in their view the decision whether a child or young person can see a health care professional, access any support needed, or be referred, investigated, or treated for long COVID should be a “shared decision involving the young person, their carers, and clinicians.”

Dr. Strain reinforced that it was important that the definition was a research one and not a clinical one, pointing out that the 12-week period in the research definition “does not necessarily mean that a child or young person should need to wait 3 months before being offered help or assistance from their health care team, indeed a 3-month delay in offering support to a child or young person, at this vitally important period of their educational development, could have lasting long-term impacts.”

A version of this article first appeared on Medscape.co.uk.