Joshua Fitch, Senior Editor

Basis for a Biologics License Application submission to the FDA is being built for PXVX0317, following topline results demonstrated in a pair of phase 3 trials, including 1 trial featuring adolescents and adults aged 12 to 64 years.

Study authors stated that several past studies have put focus on training an independent model separately for lung or heart sound diagnosis but note that having a model that can “simultaneously detect abnormal lung and heart sounds,” is essential.

Results of the randomized, multi-site study demonstrated the importance of early diabetes detection, as a single episode of diabetic ketoacidosis (DKA) in young children with type 1 diabetes was associated with lower IQ scores soon after exposure.

The resubmission, which included new long-term follow-up data and a post-hoc propensity match study, was issued a complete response letter by the federal agency, which requires “more data to support marketing approval,” according to a press release from Mesoblast Limited.

Jeanne Franzone, MD, orthopedic surgeon, surgical director, Osteogenesis Imperfecta Clinic, co-director, Prosthesis Clinic, Nemours Children’s Health, Delaware Valley, discusses recent technology, recommendations, and interactions with general health care providers in this Contemporary Pediatrics® interview.

To combat this association, study investigators concluded a reduction in daily soft drink consumption should be a priority among school-going adolescents.

In this Contemporary Pediatrics® interview, Samir Gautam, MD, (Pulmonary, Critical Care and Sleep Medicine), Yale School of Medicine, senior author of a recently published study in the Journal of Allergy and Clinical Immunology: In Practice, reviews key findings of the study and explains how they relate to the pediatric population. Watch the full interview below.

The ACIP voted in unanimous fashion, 10 to 0, to recommend routine use of nirsevimab-alip for newborns and infants younger than 8 months, born during or entering the first RSV season according to a press release from Sanofi.

Previously available under an Emergency Use Authorization, the combination test can detect and distinguish COVID-19, influenza A/B, and respiratory syncytial virus (RSV). The clearance comes ahead of respiratory season, which, according to BD, could result in another “tripledemic” threat.

In a letter addressed to the public, the FDA and Drug Enforcement Agency stated that prescription stimulant drug shortages are impacting patients and their families The agencies are taking a multifaceted approach to mitigate these shortages and find potential solutions.

Updated guidance for pediatricians that interact with children and their families, who need a potentially life-saving organ donation or transplantation, has been released by the American Academy of Pediatrics (AAP).

In this review article, take a look back at the top-performing stories from Contemporary Pediatrics from April to August 2023. With each article highlighted below, you’ll find updated news and notes along with a quick recap and direct link to our most-viewed articles.

Ervebo has been approved by the FDA to prevent the Ebola virus for individuals aged 12 months and older, after being initially approved for those 18 years and older in 2019.

Further studies are needed to determine if vaccination should be considered in children at risk for type 1 diabetes (T1D), as a COVID-19 diagnosis among children was associated with an increased incidence of T1D, according to a recent study.

If nintedanib is approved by the FDA, it would be the first and only treatment for patients aged 6 to 17 with fibrosing interstitial lung disease (ILD).

Due to a lack of evidence, the US Preventive Services Task Force (USPSTF) did not make a recommendation for or against screening for speech and delay disorder in all children 5 years or younger by primary health care professionals.

Results from a pivotal phase 2 clinical trial revealed axatilimab met the primary outcome in all cohorts for graft versus host disease (GVHD) in pediatric and adult patients. Based on its safety and efficacy profile demonstrated in clinical trials, Syndax and Incyte intend to file a biologics license application (BLA) for axatilimab with the FDA by the end of 2023.

Results from this active, facility-based surveillance study revealed hospitalization rates for children younger than 5 years were 1.7 to 7.1 times higher among American Indian and Alaska Native children compared to estimates from the methodologically similar US New Vaccine Surveillance Network (NVSN).

Following the resubmission of a new drug application, the FDA has approved VP-102 to treat molluscum contagiosum, a contagious skin disease transmitted through direct skin-to-skin contact that primarily affects children.

According to Pfizer, the investigational vaccine to protect against Group B Streptococcus (GBS) generated maternal antibody responses against 6 capsular polysaccharide serotypes and efficiently transferred antibodies to the infants. The announcement of this phase 2 data comes in July, which is International Group B Streptococcus Month.

Lorazepam, diazepam, midazolam, fentanyl, hydromorphone, morphine, ketorolac, epinephrine, diphenhydramine, and methylprednisolone were investigated in the study. Overall, the most common type of deviation was an underdose.

Overall, results from the report demonstrated that cannabis-involved emergency department (ED) visits for individuals under 25 years increased during the pandemic. For those aged 10 years or younger, the weekly number of cannabis-involved ED visits during the pandemic far exceeded the number of visits observed prepandemic.

Using 3 complementary statistical approaches of linear modeling, Bayesian, and multigroup factor analysis, investigators determined IQ scores are not negatively impacted by pediatric concussion up to 3 months postinjury.

John Bradley, MD, medical director, infectious disease, Rady Children's Hospital, San Diego, California; professor of pediatrics, UC San Diego School of Medicine, explains how recently FDA-approved nirsevimab-alip will impact the newborn and infant RSV patient population.

According to the report, 34% of parents are using patient portals for advice regarding their child’s illness.

The approval follows a unanimous vote of support from the FDA Antimicrobial Drugs Advisory Committee of nirsevimab-alip’s favorable benefit-risk profile for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants amid their first RSV season.

The FDA has identified NOxBOX Ltd’s recall of NOxBOXi Nitric Oxide Delivery System as a Class I recall. Affected devices to the newborn and neonate patient populations can cause nitric oxide therapy interruptions because of a check valve misalignment. As of July 13, 2023, no injuries or deaths have been reported according to the federal agency.

To better protect children from its several negative effects, the Environmental Protection Agency (EPA) has proposed stricter requirements for lead-based paints in pre-1978 buildings and childcare facilities.

Despite several health and nutrition claims on breast milk substitutes and infant formula products, little to no evidence supported these claims in a multicountry study published in BMJ.

To increase access and further support healthy meals in schools across the nation, the US Department of Agriculture has dedicated millions of dollars in grants to achieve this goal.