Pediatric Research最新文献

{"title":"Pediatric COVID-19 severity by SARS-CoV-2 lineage and vaccine status in Canada: an IMPACT study.","authors":"Daniel S Farrar, Julie A Bettinger, Aaron J Campigotto, Shelley L Deeks, Olivier Drouin, Joanne E Embree, Elie Haddad, Scott A Halperin, Tajdin Jadavji, Kescha Kazmi, Melanie King, Charlotte Moore Hepburn, Jesse Papenburg, Rupeena Purewal, Manish Sadarangani, Laura Sauvé, Rae S M Yeung, Karina A Top, Fatima Kakkar, Shaun K Morris","doi":"10.1038/s41390-025-03853-0","DOIUrl":"https://doi.org/10.1038/s41390-025-03853-0","url":null,"abstract":"<p><strong>Background: </strong>Interpretations of pediatric COVID-19 severity are complicated by novel lineages and COVID-19 vaccine introduction. We estimated the risk of severe COVID-19 by SARS-CoV-2 lineage and vaccination status among hospitalized Canadian children.</p><p><strong>Methods: </strong>Data were collected through the Canadian Paediatric Surveillance Program (April 2020-May 2021) and Canadian Immunization Monitoring Program, ACTive (June 2021-December 2022). Patients <17 years hospitalized for COVID-19 (excluding incidental SARS-CoV-2) at 13 pediatric hospitals were included. Lineages were defined via genetic sequencing or dominant lineage upon hospitalization. Severe disease included intensive care, ventilatory/hemodynamic requirements, systemic complications, and/or death.</p><p><strong>Results: </strong>We analyzed 3218 COVID-19 hospitalizations, including 81.4% admitted during Omicron predominance. Median age was highest among Delta cases (2.9 years, interquartile range [IQR] 0.2-10.9) and lowest among Omicron BQ.1 cases (0.6 years, IQR 0.2-1.8). Severe COVID-19 remained common in Omicron vs. ancestral cases (27.2% vs. 23.2%). The proportion of hospitalized cases aged 5-16 years declined following the introduction of age-specific COVID-19 vaccines. Vaccination reduced the risk of in-hospital severe disease for ages 12-16 years (two vs. zero doses; adjusted risk ratio 0.49, 95% confidence interval 0.32-0.77).</p><p><strong>Conclusion: </strong>More children were hospitalized with Omicron lineages than all prior lineages. COVID-19 vaccination was associated with a lower burden of severe disease among ages 5-16 years.</p><p><strong>Impact statement: </strong>This study estimates the effect of SARS-CoV-2 lineage, Omicron sub-lineage, and vaccination on COVID-19 disease severity, using data from two Canadian national surveillance programs. Few national studies describe the clinical presentation and severity of Omicron sub-lineages among hospitalized children. In Canada, Omicron lineages were associated with substantially more pediatric COVID-19 hospitalizations than all prior lineages combined, though risk of severe COVID-19 was highest during the Delta period. COVID-19 vaccines were associated with reductions in hospitalization (ages 5-16 years) and severe disease (ages 12-16 years) across Omicron sub-lineages.</p>","PeriodicalId":19829,"journal":{"name":"Pediatric Research","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143040772","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prenatal depression and child developmental vulnerability.","authors":"Naomi N Phagau, Paramdeep Kaur, Amanda Nitschke, Michael R Law, Martin Guhn, Tim F Oberlander, Gillian E Hanley","doi":"10.1038/s41390-025-03846-z","DOIUrl":"https://doi.org/10.1038/s41390-025-03846-z","url":null,"abstract":"<p><strong>Background: </strong>Prenatal depression is a potentially important fetal exposure as it may alter fetal development and have lasting effects.</p><p><strong>Methods: </strong>We examined all live births from 2001 to 2012 in British Columbia with follow-up data on the Early Development Instrument (EDI) in Kindergarten. The odds of developmental vulnerability on EDI domains among those with and without depression during pregnancy were estimated. A matched sibling analysis was run using conditional logistic regression within the same birth parent.</p><p><strong>Results: </strong>We included 130,631 births among 108,340 pregnant people, with 6089 children (4.7%) exposed to prenatal depression. Children exposed to depression during pregnancy were significantly more likely to be considered vulnerable on physical health and well-being (OR, 1.19 [95% CI, 1.10-1.29]), social competence (OR, 1.25 [95% CI, 1.15-1.36]), emotional maturity (OR, 1.18 [95% CI, 1.08-1.28]), language and cognitive development (OR, 1.14 [95% CI, 1.04-1.26]), and multiple domains (OR, 1.18 [95% CI, 1.09-1.27]). No significant associations were found in our matched sibling pair analysis, but effect sizes remained above 1 for physical health and social competences.</p><p><strong>Conclusion: </strong>More research is needed to determine whether fetal exposure to prenatal depression may predispose to childhood vulnerability on physical health and well-being, language and cognition, and socio-emotional domains.</p><p><strong>Impact: </strong>Prenatal depression is common (9-22% of pregnancies) and research has suggested a negative impact on the developing fetal brain but data on long term child development following prenatal depression is sparse. Using a unique population-based dataset with developmental data from children, we found increased risk for developmental vulnerability in physical health and well-being and socio-emotional development. Sibling matched analyses suggested the presence of some residual confounding and associations were no longer statistically significant but effects sizes did not substantially attenuate for physical health and social competence.</p>","PeriodicalId":19829,"journal":{"name":"Pediatric Research","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143040773","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Genomic interrogation of commercial infant probiotic products for label accuracy.","authors":"Christa I DeVette, Kameron Sugino, Adam Wilson, Kevin Fuller, Jacob E Friedman, Kathryn Y Burge, Hala Chaaban","doi":"10.1038/s41390-025-03831-6","DOIUrl":"https://doi.org/10.1038/s41390-025-03831-6","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the label accuracy of commercial infant probiotic products and identify potential microbial contamination.</p><p><strong>Methods: </strong>DNA was extracted from seventeen infant probiotic products purchased from a large online vendor. Samples underwent 16S ribosomal RNA gene sequencing, QIIME analysis, and bacterial taxonomic classification. Identified bacterial species were compared with product labels for label accuracy and potential contaminants. Additionally, fungal DNA was amplified using qPCR with universal 18S fungal primers, and cultures were performed to assess viability.</p><p><strong>Results: </strong>Over 82% of bacterial DNA extracted from samples corresponded to species listed on product labels. Contaminating bacteria were closely related species. Lot-to-lot variation in bacterial species abundance was greater in multi-strain products compared with single-strain products. Fungal DNA was detected in some samples, but culture results indicated these organisms were not viable.</p><p><strong>Conclusions: </strong>This pilot study highlights that most bacterial species in commercial infant probiotic products are accurately represented on labels. Single-strain products reliably match product labels whereas multi-strain products were more prone to variation of species abundance and species omission. Additionally, fungal contamination of limited samples was not viable. These findings emphasize the need for improved regulatory guidelines and standardization of probiotic products, particularly those marketed for infants.</p><p><strong>Impact: </strong>Commercial infant probiotic products were interrogated for label accuracy using 16S ribosomal RNA sequencing. Most bacterial species in commercial infant probiotic products are accurately represented on labels without pathogenic bacterial contamination. Live fungal contamination is absent. To date, no studies have interrogated infant probiotic products on this scale (other studies have been limited to single or dual strain infant probiotics). Since probiotics lack FDA regulation, this pilot study provides important information for pediatricians and consumers, further highlighting the need for improved quality control and standardization of probiotics.</p>","PeriodicalId":19829,"journal":{"name":"Pediatric Research","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143040716","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Leisure activities of adolescents-associations with demographic characteristics, well-being and parental leisure engagement.","authors":"Friederike Wanka, Mandy Vogel, Nico Grafe, Manuela Aßmann, Wieland Kiess, Tanja Poulain","doi":"10.1038/s41390-025-03866-9","DOIUrl":"https://doi.org/10.1038/s41390-025-03866-9","url":null,"abstract":"<p><strong>Background: </strong>The present study aimed to investigate associations between leisure activities and well-being, behavioral difficulties, and parental leisure time engagement.</p><p><strong>Methods: </strong>A total of 959 adolescents aged 10 to 18 years were included in the present study. We assessed their leisure activities (e.g., family time, meeting friends, screen time, sports participation), well-being (Kidscreen-27) and behavioral difficulties (Strengths and Difficulties Questionnaire SDQ) using questionnaires. The leisure behavior of parents was assessed using a parent version of the leisure activities questionnaire. We applied linear and logistic mixed-effect models to assess associations, adjusting for age, sex, and SES.</p><p><strong>Results: </strong>The associations between leisure activities and well-being differed depending on the type of activity. Active leisure (e.g., family time, meeting friends, café visits, visiting a museum/art exhibition/cinema, visiting a concert/opera, voluntary work, sports participation) was associated with better well-being, especially physical well-being, and fewer behavioral difficulties. Passive leisure activities (screen time, chilling) were associated with lower well-being and more behavioral difficulties. We also observed that adolescents reported more frequently participation in the described leisure activities if their parents did so.</p><p><strong>Conclusion: </strong>We need to promote active leisure behavior among young people and their parents to improve adolescents' well-being.</p><p><strong>Impact: </strong>Most previous studies on leisure behavior have focused on screen time and sports participation, but we examined a variety of leisure activities including family time, meeting friends, café visits, visiting a museum/art exhibition/cinema, visiting a concert/opera, voluntary work, chilling and sports participation and screen time. Active leisure activities are associated with better well-being and less behavioral problems. Parents' leisure time participation is associated with higher participation of their children in these activities. We need to promote active leisure behavior among adolescents and their parents to improve overall well-being.</p>","PeriodicalId":19829,"journal":{"name":"Pediatric Research","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143024345","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Unbound bilirubin and risk of severe neurodevelopmental impairment in extremely low birthweight newborns.","authors":"Cody C Arnold, Ivana Maric, Ronald J Wong, Jon E Tyson, David K Stevenson","doi":"10.1038/s41390-025-03872-x","DOIUrl":"10.1038/s41390-025-03872-x","url":null,"abstract":"<p><strong>Background: </strong>Unbound bilirubin (UB) was measured on day 5 ± 1 in 1101 ELBW newborns in the Aggressive vs Conservative Phototherapy randomized controlled trial. We accessed this dataset to quantify the UB-mediated risk of severe neurodevelopmental impairment (sNDI) in extremely low birthweight (ELBW) newborns.</p><p><strong>Methods: </strong>UB levels were standardized within laboratories as z-score percentiles. A dichotomous UB exposure variable was based on sharply increased risk of sNDI at the 85th percentile (UBz>85th). Targeted maximum likelihood estimation with ensemble machine learning (TMLE + ML) and logistic regression (LR) were used to estimate sNDI risk attributable to UBz>85th.</p><p><strong>Results: </strong>UB - total bilirubin correlation was poor: R² 0.24, 95% CI: 0.19, 0.30. The UB level corresponding to the UBz>85th cut-point in this cohort was estimated to be between 0.56 and 0.79 µg/dL. In 825 survivors with known sNDI status the crude risk difference (RD) associated with UBz>85th was 19.5%. With TMLE + ML, the RD was 14.4% (95% CI: 5.7%, 23.1%) corresponding to a number need to harm (NNH) of 7 (95% CI: 4, 18). LR results were similar: RD 12.4% (95% CI: 4.7%, 20.1%), NNH 8 (95% CI: 5, 21).</p><p><strong>Conclusions: </strong>Exposure to UBz>85th was associated with a large increase in risk of sNDI in ELBW newborns.</p><p><strong>Impact: </strong>Accessing the only large dataset with measures of unbound bilirubin (UB) and neurodevelopmental outcomes in extremely low birthweight (ELBW) newborns we found poor correlation between UB and total bilirubin (TB). The risk of severe neurodevelopmental impairment (sNDI) associated with UB rose non-linearly with an inflection point at UB z-score 85th percentile (UBz>85th), increasing the risk of sNDI by an estimated 14% (number need to harm: 7). The current incidence of exposure to harmful UB levels in very premature newborns is unlikely to be rare. TB levels provide a false sense of security to clinicians caring for very premature newborns.</p>","PeriodicalId":19829,"journal":{"name":"Pediatric Research","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143029339","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Isolated congenital diaphragmatic hernia and three-year neurodevelopmental outcomes.","authors":"Katsuaki Toyoshima, Hirosato Aoki, Kaoru Katsumata, Yoshiaki Sato, Hirosuke Inoue, Miharu Ito, Shoichiro Amari, Hidehiko Maruyama, Hitomi Arahori, Takuya Kondo, Kiyokazu Kim, Masaya Yamoto, Tomoko Saito, Hiroomi Okuyama, Noriaki Usui, Keita Terui, Kouji Nagata","doi":"10.1038/s41390-025-03870-z","DOIUrl":"https://doi.org/10.1038/s41390-025-03870-z","url":null,"abstract":"<p><strong>Background: </strong>To retrospectively investigate the developmental outcomes at 3 years of age in patients with congenital diaphragmatic hernia (CDH) using a multicenter collaborative research approach.</p><p><strong>Methods: </strong>We evaluated patients with CDH and no other malformations born between 2010 and 2016 in seven facilities in the Japanese CDH Research Group. The developmental quotient (DQ) at 3 years of age was evaluated using the Kyoto Scale of Psychological Development 2001, the most standardized scale in Japan. Factors associated with a DQ score < 85 were also analyzed.</p><p><strong>Results: </strong>Of 196 patients, developmental assessments at 3 years of age were performed in 132 patients (67%). Among these, 99 patients (75%) had a DQ score ≥ 85, 25 (19%) had a DQ score between 70 and 84, and 8 (6%) had a DQ score < 70. Multivariate analysis showed that the observed/expected lung area-to-head circumference ratio was an independent predictor of a DQ score < 85, with an adjusted odds ratio of 0.62 (95% confidence interval: 0.40-0.96; p = 0.03).</p><p><strong>Conclusion: </strong>Generally, isolated CDH is associated with good developmental outcomes for survivors, even after intensive care. However, there is a risk of neurodevelopmental impairment if pulmonary hypoplasia is present.</p><p><strong>Impact: </strong>This research highlights the observed/expected lung area-to-head circumference ratio (o/e LHR) as a crucial indicator to predict neurodevelopmental outcomes in 3-year-old children diagnosed with isolated congenital diaphragmatic hernia (CDH). Our results provide robust evidence from a large multicenter cohort, emphasizing the importance of o/e LHR in early risk stratification and prolonged neurodevelopmental follow-up. These findings highlight the need for comprehensive management and tailored follow-up care in CDH patients, potentially improving clinical protocols and enhancing the quality of life and outcomes for affected children.</p>","PeriodicalId":19829,"journal":{"name":"Pediatric Research","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143024344","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: Long COVID syndrome in children: neutrophilic granulocyte dysfunction and its correlation with disease severity.","authors":"Fanni Kovács, Tamás Posvai, Eszter Zsáry, Ferenc Kolonics, Réka Garai, Vivien Herczeg, Domonkos Czárán, Johanna Takács, Attila József Szabó, Péter Krivácsy, Roland Csépányi-Kömi","doi":"10.1038/s41390-025-03888-3","DOIUrl":"10.1038/s41390-025-03888-3","url":null,"abstract":"","PeriodicalId":19829,"journal":{"name":"Pediatric Research","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143029333","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Congenital hypothyroidism and associated visual-motor and intellectual development.","authors":"Esperanza Ontiveros-Mendoza, Juan Antonio González-Medrano, Rolando Rivera-González, Karla Sánchez-Huerta, Carmen Sánchez, Gerardo Barragán-Mejía","doi":"10.1038/s41390-025-03850-3","DOIUrl":"https://doi.org/10.1038/s41390-025-03850-3","url":null,"abstract":"<p><strong>Background: </strong>Congenital hypothyroidism's sequelae include visuomotor and intellectual developmental deficits. Visual-motor perception is a cognitive function related to academic performance. Intellect is the ability to learn and use acquired knowledge to solve and achieve goals. Our objective was to evaluate visual-motor and intellectual development in children with late initiation of treatment for congenital hypothyroidism enrolled in a developmental follow-up and intervention program.</p><p><strong>Methods: </strong>We evaluated the visual-motor and intellectual development of 75 infants with congenital hypothyroidism, 34 with athyrosis, and 41 with ectopia using the Bender Visual-Motor Development Test and the Weschler Intelligence Scale at eight and nine years of age.</p><p><strong>Results: </strong>Children with ectopia had a visual-motor delay of -2 years and an Intelligence Quotient (IQ) greater than 98 points. Children with athyrosis had a visual-motor delay equivalent to -3.2 years and an IQ below 90 points. Better performance on Bender's test was positively correlated with IQ. Attending more than 80% of Developmental Intervention Program appointments had a positive impact on intellectual development.</p><p><strong>Conclusions: </strong>Timely diagnosis and early treatment with the appropriate dose of levothyroxine are determining factors; however, attendance to a development follow-up and intervention program could further support the cognitive development of children with congenital hypothyroidism.</p><p><strong>Impact: </strong>Visuomotor development influences cognitive functions related to school performance. Deficits in the ability to learn and use acquired knowledge to solve problems and achieve goals are characteristic of children with congenital hypothyroidism. Delayed treatment is associated with more severe sequelae in both visual-motor and intellectual development. Here, we show that treatment with adequate doses of levothyroxine and inclusion in a follow-up and developmental program are highly recommended for patients with delayed treatment. A better understanding of these factors will allow clinicians to target therapeutic interventions.</p>","PeriodicalId":19829,"journal":{"name":"Pediatric Research","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143024315","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Caregiver report of infant behavior associated with autism likelihood in first year of life.","authors":"Erin M Andres, Shaina P Brady, Italia Camillone, Casey A Cragin, Melissa A Clark, Barry M Lester, Gavino Puggioni, Stephen J Sheinkopf","doi":"10.1038/s41390-025-03867-8","DOIUrl":"10.1038/s41390-025-03867-8","url":null,"abstract":"<p><strong>Background: </strong>Identification of prodromal indicators of autism in infancy has the potential to identify behaviors relevant to early autism screening.</p><p><strong>Methods: </strong>We report on data from a prospective general population birth cohort with maternal reported measures at 9 and 12 months: the Survey of Well-Being of Young Children (SWYC; general developmental surveillance) and the First Year Inventory-Lite v3.1b (FYI-Lite; autism specific parent report research tool). Mothers completed the surveys and the Broad Autism Phenotype Questionnaire (BAPQ), a self-report measure of subclinical features of autism.</p><p><strong>Results: </strong>In this sample of 332 infants (168 males), maternal-reported infant developmental milestones and behavioral indicators of difficult temperament, poor adaptability, and sleep problems at 9 months (SWYC) and maternal self-reported subclinical autism characteristics (BAPQ) were correlated with maternal-reported autism-related behaviors on the FYI-Lite at 12 months. Regression models revealed significant unique associations between infant temperament, developmental milestones, and FYI-Lite scores while controlling for significant effects of maternal BAPQ scores and education.</p><p><strong>Conclusions: </strong>Maternal report of infant temperament and developmental milestones at 9 months were associated with maternal-report early indicators of autism likelihood at 12 months in a general birth cohort. Follow up of this cohort is needed to determine associations with formal diagnostic outcomes.</p><p><strong>Impact: </strong>Identifying scalable measures of infant behaviors in general and specific to autism may help identify targets of intervention for infants in the first year of life. This study aims to contribute to improved first-year surveillance by assessing potential early autism indicators in a prospective general birth cohort, whereas other observational studies utilize enriched risk cohorts (e.g., infant siblings of autistic children). Preliminary findings of this cohort revealed that a maternal report of 9-month temperament significantly predicted higher scores on a maternal report 12-month autism screener and indicated the importance of considering maternal self-reported subclinical autism characteristics when interpreting parent report screeners.</p>","PeriodicalId":19829,"journal":{"name":"Pediatric Research","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143024313","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Persistent exclusion of non-English speakers in Pediatric research: a national analysis using ClinicalTrials.gov.","authors":"Akila V Muthukumar, Kavya M Shah, Robert J Glynn, Barbara E Bierer","doi":"10.1038/s41390-025-03845-0","DOIUrl":"https://doi.org/10.1038/s41390-025-03845-0","url":null,"abstract":"<p><p>Over one-fifth of US households speak a language other than English. While some studies have documented language-based disparities in pediatric clinical research, they are limited in scope and not representative of all US pediatric trials. Because language-based exclusion, if extensive, would limit the generalizability of the results of the research, we performed a systematic analysis of language-based eligibility criteria across all 4982 US pediatric interventional clinical trials registered on ClinicalTrials.gov from 2019 to 2022. We found that 70.0% [95% CI: 68.8-71.3%] of trials did not include any information about language while 23.4% [22.2-24.5%] had explicit English language requirements, of which only a minority (14.4%) included justifications for the limitation. Conversely, 6.6% [5.9-7.3%] of trials accommodated non-English languages. Trials with a posted protocol were more likely than all registered trials to include English language requirements (P < 0.00001). Trials with a federal sponsor, a behavioral intervention, or a focus on prevention or supportive care were more likely to report information about language when compared to all registered trials (P < 0.001), while trials with industry sponsors, drug or biological interventions, or a focus on treatment were less likely to do so (P < 0.001). Although modest, the percentage of trials requiring English decreased and the percentage offering language services increased from 2019 to 2022. IMPACT STATEMENT: Of 4982 US pediatric interventional studies registered on ClinicalTrials.gov from 2019 to 2022, 70.0% did not include any information about language while 23.4% explicitly included English language requirements. Of the trials requiring English, only 14.4% provided a justification for the requirement. Trials with a posted protocol were more likely to require English than all registered trials. Trials with industry sponsors, drug-based/biological interventions, or a treatment focus were less likely to mention language information than all registered trials.</p>","PeriodicalId":19829,"journal":{"name":"Pediatric Research","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143024251","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}