Celeste Krewson

Medical devices are often not given proper testing for pediatric use, lacking clinical evidence that they are both safe and effective on children, according to researchers from Harvard Medical school. To find out more, these investigators examined high-risk cardiovascular devices approved by the US Food and Drug Administration (FDA) for use in children and adolescents.

Data was taken from the premarket approval and humanitarian device exemption databases from the years 1977 to 2021. This data revealed which high-risk cardiovascular devices were FDA-approved. According toa research letter from the 

Journal of the American Medical Association,

 only 8.6% of the devices approved in the study period were also approved for pediatric use. Most of these devices were for all pediatric ages,except forone-third of the devices being approved only for patients aged 18 years and older.

Investigators noted that many of the high-risk cardiovascular devices used in children are repurposed from those used in adults. Of the devices approved for pediatric use, less than half were tested in a clinical trial involving children. Because of this, the researchers concluded that more regulatory processes and industry assessments would be necessary fordevices to be properly evaluated for use in children.

Of the devices that were approved for pediatric use, many were defibrators, stents, and prosthetic valves. Almost half were implantable, and over 40% were considered lifesaving. As not many studies were required to enroll children, further evidence was not collected. This factor was made worse by the low completion rate for these studies.

Given the unique anatomy of children and adolescents compared to adults, the investigators recommended further studies to collect evidence on the effectiveness and safety of pediatric devices.

Wunnava S, Miller TA, Narang C, Nathan M, Bourgeois FT. US Food and Drug Administration approval of high-risk cardiovascular devices for use incChildren and adolescents, 1977-2021. JAMA. 2022;328(6):580–582. doi:10.1001/jama.2022.10041

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Many devices approved for pediatric use were not tested in a clinical trial involving children.

Few pediatric devices were approved after a clinical trial involving children 

Only a minority of parents with children aged 6 months to 4 years plan to get their children vaccinated from COVID-19 within their first few months of eligibility. Many others have concerns about the vaccine for children of this age group, according to a recent study published in the Journal of the American Medical Association.

These findings are from a cross-sectional study of 2031 adults in the United States with children who fall under the age range of 6 months to 4 years. Of these participants, almost half indicated intention of getting their children vaccinated against COVID-19, but only one-fifth stated a plan to do so within 3 months after their children are eligible.

To enter the survey, parents had to live in the United States, be regularly responsible for a child aged 6 months 4 years living with them, identify as Black, Hispanic, or White, and show that they would answer each question to the best of their abilities. The child age group of these recipients was split evenly between children aged 6 to 23 months and those aged 2 to 4 years, and the gender of the respondents was split closely between male and female.

Questions on the survey included, “How likely are you to get a COVID-19 vaccine for your [age] child, if they become eligible for vaccination?” and “How long do you think you will wait before getting a COVID-19 vaccine for your [age] child if they became eligible for vaccination?” Parents who said they would “definitely not” get their child the vaccine were then asked to complete a concerns measure. In this measure, they discussed their concerns, facilitators, and preferred vaccination locations.

Those with intentions to get the vaccine for their children were more often male, Hispanic, more education, and were vaccinated themselves. Nearly 20%of the respondents said they would vaccinate their children within 3 months of the child’s eligibility, while 47.3% said they would wait longer and 33.7% did not have a plan for when they would get their child vaccinated.

The most common facilitator for those who did not plan to get the vaccine for their child was the safety and efficacy of the vaccine in children of this age group. Following this, full US Food and Drug Administration approval of the vaccine and an increase in the severity of COVID-19 cases were mentioned. About two-thirds of respondents expressed comfort in getting their child vaccinated at their regular doctor or clinic.

Most respondents indicated concerns over the vaccine’s safety and efficacy. The investigators state that these concerns, “highlights that widespread hesitancy around COVID-19 vaccination for children younger than 5 years exists, even among those who are inclined to vaccinate their child in this age group.”They also suggest increased efforts to improve parents’ confidence in the COVID-19 vaccine for children aged 6 months to 4 years.

Scherer AM, Gidengil CA, Gedlinske AM, et al. COVID-19 vaccination intentions, concerns, and facilitators among us parents of children ages 6 months through 4 years. 

 2022;5(8):e2227437. doi:10.1001/jamanetworkopen.2022.27437

Only one-fifth of parents in a recent survey indicated intentions of getting their child the vaccine within 3 months of eligibility.

Parents express low confidence in pediatric COVID-19 vaccine 

An increase in deaths by gun violence in children was observed during the COVID-19 pandemic. In the years of 2020 to 2022, the number of children killed by gun violence is of a similar size to those killed directly by the SARS-CoV-2 virus.

Data was taken from the Gun Violence Archive (GVA) to examine the rates of gun violence from January 1, 2014, to December 31, 2022. Investigators organized the data into periods of 28 days. Periods from the middle of March 2020 onward were compared with those prior. Subgroups were based on child age, household income, and percentage of Black or Hispanic population.

From March 2020 onward, an increase in child deaths by gun violence was observed. These deaths increased at an estimated rate of 1.12 children per day. During the study period, 733 child deaths were recorded. This figure compares to data from the US Centers for Disease Control and Prevention (CDC), which recorded 752 child deaths caused directly by COVID-19 in the same time period.

In the child deaths from gun violence observed, 22.3% were children aged 0 to 11 years, while 77.7% were aged 12 to 17 years. Moreover, 19.6% of these deaths were girls, while 78.8% were boys, while the gender of 1.7% of the children was unknown.

Deaths from gun violence were most often seen increasing in low median income households, or in an area with a higher percentage of Black or Hispanic population. Nearly 60% of the recorded deaths were from a high-minority area, meaning that more than half of the population in these areas was Black or Hispanic. The study investigators deduced that, “family and neighborhood socioeconomic conditions may be important mediators.” 

The authors also mentioned other factors which may have led to an increase in gun violence but have not been proven. These include the closure of schools and the increase in stress within families due to lockdowns. Economic strain could also be a factor in gun-related deaths.

Peña PA, Jena A. Child deaths by gun violence in the us during the covid-19 pandemic. 

 2022;5(8):e2225339. doi:10.1001/jamanetworkopen.2022.25339

Studies indicate that child deaths by gun violence were comparable to those by COVID-19.

Child death by gun violence increased during COVID-19 pandemic

Smoking tobacco while pregnant can lead to one’s child experiencing lower brain volumes and suboptimal cortical traits, according to a study by The Journal of the American Medical Association (JAMA).

Investigators conducted brain morphology in children aged 9 to 11 years. Over 2700 study participants had been exposed to maternal smoking during pregnancy, and a subsample of 784 patients had recorded DNA methylation. Magnetic resonance imaging (MRI) was used to examine brain volumes and surface-based cortical measures in patients.

Study participants underwent a brain MRI assessment, and it was found that those who were exposed to maternal smoking during pregnancy had a smaller total brain volume (TBV) than those not exposed. Specifically, children who were continuously exposed during pregnancy were observed to have lower TBV levels, and there was less gyrification observed in children exposed to maternal smoking. 

These changes in brain morphology were not found in children who were only exposed early in the pregnancy. Children exposed to maternal smoking in only the first trimester were found to have the same brain morphology as children not exposed at all.

Paternal smoking was shown to have effects as well, with both maternal and paternal smoking leading to a larger putamen in the child by the time they were 10 years of age. There were far more cases of brain morphology reported in cases of maternal smoking, however. No association was made between paternal smoking and changes in the cortical thickness, surface area, or gyrificationof the child.

No proof was found that DNA methylation at birth could mediate the effects of maternal smoking. However, it should be noted that all the children in the DNA methylation subsample were White, and the results cannot be assumed to be the same for other races and ethnicities.

Based on these findings, continuous tobacco use during maternal pregnancy will often lead to complications in the child’s brain developed by the time they are aged 10 years. These complications are seemingly not able to be explained by shared genetics or family factors.

These results are consistent with those of prior studies, which also showed smaller brain sizes in fetuses and children exposed to continuous maternal smoking. For favorable long term brain development in children, the authors encouraged ceasing maternal smoking before pregnancy starts or early in pregnancy.

Zou R, Boer OD, Felix JF, et al. Association of maternal tobacco use during pregnancy with preadolescent brain morphology among offspring. 

 2022;5(8):e2224701. doi:10.1001/jamanetworkopen.2022.24701

Smoking tobacco should cease during pregnancy, according to The Journal of the American Medical Association.

Smoking during pregnancy associated with smaller brain volume in child

The American Academy of Pediatrics (AAP) has announced revisions to the clinical guidelines for treating infants with hyperbilirubinemia who are born 35 weeks or more into pregnancy. Hyperbilirubinemia most often leads to jaundice, a condition where the skin and whites of the eyes take on a yellow appearance. However, symptoms are sometimes more severe, leading to complications in the brain.

Chair of the guideline authoring committee Alex R. Kemper, MD, MPH, MS, FAAP, discussed the importance of hospitals and clinicians having plans to help prevent hyperbilirubinemia in newborns.

One of these plans was to measure bilirubin levels in babies. High levels of bilirubin can lead to a permanent brain condition known as kernicterus, which can cause cerebral palsy and severe movement problems.

“This is why we need to make sure clinicians understand why it is important to test bilirubin levels and for families to understand their babies’ risk and recommended follow-up,” said Kemper.

If a case of hyperbilirubinemia is severe, exchange transfusion can be used as treatment instead. During exchange transfusion, the patient’s blood is rapidly replaced so that bilirubin levels may be lowered. One of the recent revisions made by the AAP suggested using this method less than before, raising the threshold for exchange transfusion along with phototherapy. This change came because of research published in 2004 that implied toxicity is caused in higher levels of bilirubin than initially thought.

“Fortunately, kernicterus is rare, but the impact on children and their families can be devastating,” said Kemper. “The guideline provides clinicians, birthing centers, and hospitals with strategies to prevent the worst-case scenarios and to help educate families so they recognize the signs of jaundice and know when to follow-up with their pediatrician.”

To cause more timely follow ups, the AAP revised the risk assessment approach to suggest the right times for measuring bilirubin levels. This approach is based on the difference between the infant’s bilirubin levels and the phototherapy threshold. The potential harm of phototherapy was a key factor in the development of the AAP’s guidelines.

These new findings were included in the “Clinical Practice Guideline Revision: Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation,” which will be published in the September 2022 issue of Pediatrics. This issue was published online August 5, 2022.

American Academy of Pediatrics revises clinical guidelines for preventing, treating, and monitoring hyperbilirubinemia in newborns. August 5, 2022. Accessed August 5, 2022. 

http://www.aap.org/en/news-room/news-releases/aap/2022/american-academy-of-pediatrics-revises-clinical-guidelines-for-preventing-treating-and-monitoring-hyperbilirubinemia-in-newborns/

Hyperbilirubinemia can lead to brain complications in rare instances, which the guidelines work to prevent.

AAP announces revisions to clinical guidelines for hyperbilirubinemia treatment in infants 

August is National Immunization Awareness Month (NIAM), and the American Academy of Pediatrics (AAP) has urged parents to talk to pediatricians during this time about childhood and adolescent vaccines. As immunization rates in children decline, parents should find out if their children have fallen behind on vaccines. If so, they should catch their children up on vaccinations they may have missed.

With COVID-19 causing people to stay home, an estimated 25 million children missed their immunizations last year worldwide. This is the largest decline in immunization recorded in the last 30 years. A similar trend occurred in the 2021 to 2022 school year, leading to tens of thousands more children in the United States being unprotected against specific diseases.

With immunization towards diseases such as whooping cough, measles, and mumps falling, AAP President Moira Szilagyi, MD, PhD, FAAP, urged parents to take their children to a pediatrician for a checkup. At the same time, Szilagyisuggests children get caught up on their COVID-19 vaccine. Outbreaks of diseases may rise as more people travel. This makes it more important to protect children from these preventable disease outbreaks.

To help with this task, the AAP recommended different resources. One of these resources was “

,” an interactive immunization map which shows childhood vaccination rate per state.The data on this map, updated annually, comes from the Centers for Disease Control and Prevention National Immunization Survey. Updates will be made which add 

 on how to use the map. To obtain immunization data for a state, a user can hover their cursor over that state on the map.

Other resources were offered as well, such as 

, an interactive tool on HealthyChildren.org that allows parents to discover answers to questions they may have about vaccines. Answers to common questions about vaccines were also made into videos, which the AAP compiled into a 

The AAP reminded readers that COVID-19 vaccines have been recently approved for children under the age of 5 years. With this approval, the AAP urged parents to take their children to a pediatrician so they could be vaccinated. This could be a chance to get their children immunization against not only COVID-19, but other diseases as well.

As Child and Adolescent Immunization Rates Hit Historic Lows Due to Pandemic, AAP Urges Parents to Check on their Child’s Immunizations and to Vaccinate Against COVID. American Academy of Pediatrics. July 28, 2022. Accessed August 4, 2022. https://www.aap.org/en/news-room/news-releases/aap/2022/as-child-and-adolescent-immunization-rates-hit-historic-lows-due-to-pandemic-aap-urges-parents-to-check-on-their-childs-immunizations-and-to-vaccinate-against-covid/

As immunization rates fall in children, the American Academy of Pediatrics recommends a checkup with physicians. 