Pediatrics最新文献

{"title":"Haemophilus influenzae Type b Vaccine Immunogenicity in American Indian/Alaska Native Infants.","authors":"Bianca D Jackson, Karen Miernyk, Jonathan Steinberg, Jeanette Beaudry, Loretta Christensen, Uzo Chukwuma, Demetria Clichee, Shawnell Damon, Brooke Amara Farrenkopf, Chloe Hurley, Juan Luna, Brenna Simons, Rosalyn Singleton, Mary Thomas, Dan VanDeRiet, Robert Weatherholtz, Scott Zeger, Sarah Zylstra, James Keck, Laura L Hammitt","doi":"10.1542/peds.2024-066658","DOIUrl":"10.1542/peds.2024-066658","url":null,"abstract":"<p><strong>Objectives: </strong>American Indian and Alaska Native (AI/AN) infants historically experienced a disproportionate burden of invasive Haemophilus influenzae type b (Hib) disease, especially early in life. PedvaxHIB vaccine is preferentially recommended for AI/AN infants because it elicits protective antibody levels postdose 1. Vaxelis, a hexavalent vaccine that contains the same Hib conjugate as PedvaxHIB but at lower concentration, is recommended for US children, but postdose 1 Hib immunogenicity data are needed to inform whether a preferential recommendation should be made for AI/AN infants.</p><p><strong>Methods: </strong>We conducted a phase IV randomized, open-label, noninferiority trial comparing postdose 1 immunogenicity of Vaxelis to PedvaxHIB in AI/AN infants. Participants were randomized to receive a primary series of PedvaxHIB or Vaxelis. Serum samples collected 30 days postdose 1 were tested for anti-Hib immunoglobulin G antibody by enzyme-linked immunosorbent assay. The anti-Hib immunoglobulin G geometric mean concentration (GMC) ratio (Vaxelis/PedvaxHIB) was estimated by constrained longitudinal data analysis. Noninferiority was defined a priori as the lower bound of the 95% confidence interval (CI) of the GMC ratio ≥0.67.</p><p><strong>Results: </strong>A total of 327 of the 333 infants enrolled in the study were included in the per-protocol analysis. The postdose 1 anti-Hib GMC was 0.41 µg/mL (95% CI 0.33-0.52) in the Vaxelis group (n = 152) and 0.39 µg/mL (95% CI 0.31-0.50) in the PedvaxHIB group (n = 146). The constrained longitudinal data analysis GMC ratio was 1.03 (95% CI 0.76-1.39).</p><p><strong>Conclusions: </strong>Postdose 1 immunogenicity of Vaxelis was noninferior to PedvaxHIB. Our findings support the use of Vaxelis in AI/AN children, a population with elevated risk of Hib disease.</p>","PeriodicalId":20028,"journal":{"name":"Pediatrics","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142308290","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The RACE Act and Pediatric Trials of Adult Cancer Drugs.","authors":"Ian T T Liu, Aaron S Kesselheim","doi":"10.1542/peds.2024-066920","DOIUrl":"10.1542/peds.2024-066920","url":null,"abstract":"<p><p></p><p><strong>Background and objectives: </strong>Adult cancer drugs have historically been exempted from pediatric testing requirements. In 2017, Congress passed the Research to Accelerate Cures and Equity (RACE) for Children Act to expand mandatory pediatric testing to cancer drugs; the law took effect in 2020. With this study, we sought to evaluate how the pediatric testing of molecularly targeted adult cancer drugs changed after the RACE Act.</p><p><strong>Methods: </strong>In this retrospective cohort study, we used publicly available Food and Drug Administration data to compare pediatric post-approval requirements, trials, and trial characteristics, including timing, in adult cancer drugs before and after the RACE Act.</p><p><strong>Results: </strong>Between 2017 and 2024, the Food and Drug Administration approved 61 adult cancer drugs with molecular targets relevant to pediatric cancer; 40 were submitted before 2020, and 21 were submitted after 2020. The 40 pre-RACE Act drugs were associated with no pediatric post-approval requirements, whereas the 21 post-RACE Act drugs were associated with 15 pediatric post-approval testing requirements. Approximately two-thirds (26/40, 65%) of pre-RACE Act drugs and 57% (12/21) of post-RACE Act drugs were evaluated in pediatric trials. Among pre-RACE Act cancer drugs, pediatric trials were initiated a median of 0.04 years after approval (interquartile range: -3.3 to 1.9 years), whereas post-RACE Act trials were initiated a median of 2.8 years before approval (interquartile range: -4.3 to 0.3 years).</p><p><strong>Conclusions: </strong>The RACE Act has been associated with greater numbers of pediatric post- approval testing requirements and the earlier initiation of pediatric trials, although early pediatric trial rates appear unchanged. Formalizing pediatric testing requirements may lead to the timely completion of pediatric studies to the benefit of pediatric patients with cancer.</p>","PeriodicalId":20028,"journal":{"name":"Pediatrics","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142126289","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"School Suspension and Expulsion: Policy Statement.","authors":"Susanna K Jain, Nathaniel Beers, Ryan Padrez","doi":"10.1542/peds.2024-068466","DOIUrl":"https://doi.org/10.1542/peds.2024-068466","url":null,"abstract":"<p><p>Exclusionary school discipline practices-ie, suspension and expulsion-represent some of the most severe consequences a school district can implement for unacceptable student behavior. Suspension and expulsion were traditionally used for student behaviors that caused serious harm, such as bringing a weapon to school. Currently, the most common indications for exclusionary school discipline are for behaviors that are neither violent nor criminal. There is little evidence that exclusionary school discipline practices make schools safer or deter future misbehavior. American Indian/Alaska Native students, Black students, students whose caregivers have low socioeconomic status, male students, lesbian, gay, bisexual, transgender, and queer or questioning students, and students with disabilities are disproportionately disciplined with suspension and expulsion. In addition, exclusionary school discipline in the preschool period can be harmful to early childhood development. Children and adolescents affected by exclusionary school discipline are at higher risk for dropping out of high school and for involvement with the juvenile justice system. Both of those experiences are associated with a worse profile of physical and mental health outcomes. A multidisciplinary and trauma-informed approach to reducing exclusionary school discipline practices is described. Recommendations are provided at both the practice level for pediatric health care providers and at the systems level for both pediatric health care providers and educators.</p>","PeriodicalId":20028,"journal":{"name":"Pediatrics","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142351930","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Recently Recalled Children's Products Due to Lead Hazards.","authors":"Paul Allwood, Perri Zeitz Ruckart, Qaiyim Harris","doi":"10.1542/peds.2024-067808P","DOIUrl":"10.1542/peds.2024-067808P","url":null,"abstract":"<p><strong>Objective: </strong>We reviewed recent reports of recalled children's products contaminated with lead to learn more about what could be done to inform public health partners about the recalls in a timely manner to assist with broader consumer notification for proactive lead poisoning prevention efforts.</p><p><strong>Methods: </strong>Centers for Disease Control and Prevention staff reviewed lead-related recall notices for children's products issued during June 2022 through April 2024. Recall notices were extracted from the Consumer Product Safety Commission using Really Simple Syndication feed technology to identify and capture the most current recall information. Specific product details in the database were extracted and analyzed descriptively to identify response trends and best practices.</p><p><strong>Results: </strong>Centers for Disease Control and Prevention's automated tool identified 30 recalls from Consumer Product Safety Commission. Lead-contaminated toys were the most frequent type of product recalled (n = 11, 37%). Most products were manufactured in China (n = 24, 86%). Products were on the market for an average of 25 months before they were recalled. No injuries were reported. The 30 recalls resulted in a combined number of 914 598 recalled units sold.</p><p><strong>Conclusions: </strong>The current approach to protecting children from lead hazards in consumer products could be augmented by timely notifying the public health community about recalls so they can broadly disseminate information through their channels to reduce lead exposure in children. Additional steps to reduce lead contamination in children's products when sourcing raw materials and components may help to decrease the number of recalls.</p>","PeriodicalId":20028,"journal":{"name":"Pediatrics","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142351944","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Universal Lead Testing in Pregnancy: A Call to Action.","authors":"Katherine M Johnson, Alan D Woolf, Marissa Hauptman, Blair J Wylie","doi":"10.1542/peds.2024-067808I","DOIUrl":"https://doi.org/10.1542/peds.2024-067808I","url":null,"abstract":"","PeriodicalId":20028,"journal":{"name":"Pediatrics","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142351950","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"June 2024 ACIP Meeting Update: Influenza, COVID-19, RSV, and Other Vaccines.","authors":"Alexandra B Yonts, Claudia Gaviria-Agudelo, David W Kimberlin, Grant C Paulsen, Sean T O'Leary","doi":"10.1542/peds.2024-068310","DOIUrl":"10.1542/peds.2024-068310","url":null,"abstract":"<p><p>The Advisory Committee on Immunization Practices (ACIP), a group of medical and public health experts that provides advice to the Centers for Disease Control and Prevention, normally meets 3 times per year to develop US vaccine recommendations. The ACIP met June 26 through 28, 2024. This update summarizes the proceedings of this meeting, with an emphasis on topics that are most relevant to the pediatric population. Major updates for pediatric clinicians include COVID-19 and influenza vaccine recommendations for the 2024 to 2025 season, meningococcal vaccination considerations, information regarding preferred Haemophilus influenzae type B containing vaccines for American Indian and Alaskan Native infants, and updates regarding implementation and effectiveness of RSV immunization in pregnant people and infants.</p>","PeriodicalId":20028,"journal":{"name":"Pediatrics","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141793054","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Maternal Disability and Early Child Preventive Care.","authors":"Hilary K Brown, Clare Taylor, Andi Camden, Yona Lunsky, Simone Vigod, Maria Santiago, Kinwah Fung, Eyal Cohen, Astrid Guttmann, Deanna Telner, Joel Ray, Jennifer Zwicker, Natasha Saunders","doi":"10.1542/peds.2024-066069","DOIUrl":"10.1542/peds.2024-066069","url":null,"abstract":"<p><p></p><p><strong>Objectives: </strong>Preventive health care for children comprises routine well-child visits and immunizations. Women with physical, sensory, or intellectual or developmental disabilities tend to experience more barriers to preventive health care; yet it is unknown whether such barriers are observed among their young children.</p><p><strong>Methods: </strong>This population-based study in Ontario, Canada included children born between 2012 and 2019 whose mothers had a physical (n = 74 084), sensory (n = 26 532), or intellectual or developmental (n = 1391) disability, multiple disabilities (n = 5774), or no disability (n = 723 442). Primary outcomes were receipt of the recommended number of well-child visits and routine immunizations in the first 2 years. Secondary outcomes included receipt of the enhanced 18-month developmental assessment and any developmental screen. Relative risks (aRR) were generated using modified Poisson regression and adjusted for maternal sociodemographics and mental health and child sex.</p><p><strong>Results: </strong>Compared with children of mothers without disabilities, those whose mothers had intellectual or developmental disabilities were less likely to receive the recommended number of well-child visits (56.3% vs 63.2%; aRR 0.92, 95% confidence interval [CI] 0.88-0.97), routine immunizations (43.8% vs 53.7%; aRR 0.88, 95% CI 0.83-0.94), enhanced 18-month developmental assessment (52.3% vs 60.8%; aRR 0.92, 95% CI 0.88-0.97), or any developmental screen (54.9% vs 62.5%; aRR 0.94, 95% CI 0.90-0.99). Other disability groups did not experience such disparities.</p><p><strong>Conclusions: </strong>There is a need to develop resources to improve access to preventive health care for young children of women with intellectual or developmental disabilities.</p>","PeriodicalId":20028,"journal":{"name":"Pediatrics","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142293132","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Lead's Last Mile.","authors":"Aaron Bernstein","doi":"10.1542/peds.2024-067808B","DOIUrl":"10.1542/peds.2024-067808B","url":null,"abstract":"<p><p></p>","PeriodicalId":20028,"journal":{"name":"Pediatrics","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142351941","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"State-Level Childhood Lead Poisoning Prevention Policies and Practices in the United States: 2022-2023.","authors":"Perri Zeitz Ruckart, Rio Schondelmeyer, Alexis Allen, Paul Allwood","doi":"10.1542/peds.2024-067808N","DOIUrl":"10.1542/peds.2024-067808N","url":null,"abstract":"<p><strong>Objectives: </strong>The purpose of this analysis is to better understand laws and practices guiding prevention activities in childhood lead poisoning prevention programs funded by the Centers for Disease Control and Prevention (CDC).</p><p><strong>Methods: </strong>In 2022, CDC surveyed 62 funded programs using the Awardee Lead Profile Assessment. Information was collected about childhood lead poisoning-related laws and guidance, surveillance and prevention strategies, and program services including at what blood lead levels (BLLs) various activities are performed. Separately, CDC reviewed state health department websites to obtain information on which states implemented CDC's updated blood lead reference value.</p><p><strong>Results: </strong>Awardee Lead Profile Assessment results are only reported for 47 states, the District of Columbia, and Puerto Rico. Almost all programs (96%) have laws requiring reporting of BLLs, and 51% require BLLs be reported electronically to jurisdictional health departments. Most programs (80%) prioritize areas and populations that are high risk for lead poisoning prevention activities. Approximately half of the programs (51%) have a lead elimination plan or goal. Thirty-nine percent of the programs have already implemented policies, laws, or regulations to achieve lead elimination, and 74% are in the Northeast and Midwest regions of the country. As of March 2023, 71% of the programs have implemented CDC's updated blood lead reference value, and most (65%) did so via guidance for health care providers and laboratories for what BLL should initiate case management and other services for lead-exposed children.</p><p><strong>Conclusions: </strong>Almost all programs have mandatory BLL reporting laws, and about two-thirds of the programs updated their BLLs that trigger public health action.</p>","PeriodicalId":20028,"journal":{"name":"Pediatrics","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142351947","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evolution of Treatment Modalities for Disseminated HAdV Infection in Neonates.","authors":"Wenjing Zhang, Fang Liu, Enlin Liang, Li Zhang","doi":"10.1542/peds.2024-066677","DOIUrl":"10.1542/peds.2024-066677","url":null,"abstract":"<p><p>Human adenovirus (HAdV) infection in newborns is a rare condition that typically affects multiple organ systems and has a high mortality rate. We report a case of neonatal HAdV-D37 infection that presented with fever and respiratory distress that was confirmed by metagenomic next-generation sequencing using blood and bronchoalveolar lavage fluid. We treated the patient with intravenous immunoglobulin, methylprednisolone, and anticoagulants, and the patient recovered. Our review of 41 cases of HAdV found that treatment with intravenous immunoglobin might have improved the outcome of HAdV-D infection. We further suggest that glucocorticoid therapy may have additional therapeutic validity in the setting of severe or disseminated disease and that monitoring coagulation function and timely anticoagulation treatment should be considered to prevent complications associated with disseminated intravascular coagulation.</p>","PeriodicalId":20028,"journal":{"name":"Pediatrics","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142140782","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}