{"title":"Conditional and Unconditional Social Transfers, Early-Life Nutrition, and Child Growth","authors":"Jordyn T. Wallenborn, Souliviengkham Sonephet, Somphou Sayasone, Latsamy Siengsounthone, Sengchanh Kounnavong, Günther Fink","doi":"10.1001/jamapediatrics.2024.5079","DOIUrl":"https://doi.org/10.1001/jamapediatrics.2024.5079","url":null,"abstract":"ImportanceRates of exclusive breastfeeding are declining despite the numerous benefits to mothers and their children.ObjectiveTo assess the effectiveness of conditional and unconditional social transfers on exclusive breastfeeding rates and child growth.Design, Setting, and ParticipantsThis is a prospective, parallel, 3-armed randomized clinical trial conducted between August 2022 and October 2023. The trial was conducted in 4 districts of Vientiane, Lao People’s Democratic Republic. Mothers identified from a large birth cohort were randomized into 2 intervention groups (conditional social transfer or unconditional social transfer) or a control group at a ratio of 1:1:1. Data analysis was conducted from December 2023 to January 2024.InterventionsTwo interventions were tested: (1) conditional social transfer, in which the mother received the social transfer only if still exclusively breastfeeding at 6 months, and (2) unconditional social transfer, in which the mother received the social transfer at 6 months regardless of breastfeeding status. Mothers in the control group received educational material only.Main Outcomes and MeasuresThe primary outcome was the proportion of women exclusively breastfeeding at 6 months post partum. Secondary outcomes included exclusive breastfeeding duration (in months) and child growth (height, weight, and head circumference).ResultsA total of 298 mothers (mean [SD] age, 27.2 [6.5] years) were identified from a large birth cohort and randomized into a conditional social transfer group (n = 100), an unconditional social transfer group (n = 97), or a control group (n = 101). The adjusted odds ratio of exclusive breastfeeding at 6 months post partum was 4.60 (95% CI, 2.10-10.07; <jats:italic>P</jats:italic> &amp;lt; .001) for the conditional social transfer group and 2.51 (95% CI, 1.11-5.66; <jats:italic>P</jats:italic> = .03) for the unconditional social transfer group compared with the control group. The risk of early exclusive breastfeeding cessation was lower for participants who received the unconditional social transfer (adjusted hazard ratio [aHR], 0.68; 95% CI, 0.49-0.92; <jats:italic>P</jats:italic> = .02) or conditional social transfer (aHR, 0.60; 95% CI, 0.44-0.83; <jats:italic>P</jats:italic> = .002) compared with participants in the control group. There were no significant differences between groups for child growth at 6 months post partum.Conclusions and RelevanceThe findings suggest that social transfers can substantially improve exclusive breastfeeding rates at 6 months post partum, with particularly large benefits for conditional transfers. Continued evaluation at 1, 2, and 3 years post partum will be conducted to assess the long-term outcomes of social transfers on complementary breastfeeding and child health and development over time.Trial RegistrationClinicalTrials.gov Identifier: <jats:ext-link xmlns:xlink=\"http://www.w3.org/1999/xlink\" ext-link-type=\"uri\" xlink:href=\"https://clinicaltrials.gov/","PeriodicalId":14683,"journal":{"name":"JAMA Pediatrics","volume":"47 1","pages":""},"PeriodicalIF":26.1,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142825469","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JAMA PediatricsPub Date : 2024-12-16DOI: 10.1001/jamapediatrics.2024.5437
Ryan C. L. Brewster, Matthew Nagy, Susmitha Wunnava, Florence T. Bourgeois
{"title":"US FDA Approval of Pediatric Artificial Intelligence and Machine Learning–Enabled Medical Devices","authors":"Ryan C. L. Brewster, Matthew Nagy, Susmitha Wunnava, Florence T. Bourgeois","doi":"10.1001/jamapediatrics.2024.5437","DOIUrl":"https://doi.org/10.1001/jamapediatrics.2024.5437","url":null,"abstract":"This cross-sectional study analyzes the availability of artificial intelligence and machine learning–enabled devices authorized for children by the US Food and Drug Administration (FDA) and assesses reporting of algorithm validation in the pediatric population.","PeriodicalId":14683,"journal":{"name":"JAMA Pediatrics","volume":"252 1","pages":""},"PeriodicalIF":26.1,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142825540","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JAMA PediatricsPub Date : 2024-12-16DOI: 10.1001/jamapediatrics.2024.5536
Jeromie Ballreich, Ilina C. Odouard, Mariana P. Socal
{"title":"The CMS Sickle Cell Gene Therapy Access Model","authors":"Jeromie Ballreich, Ilina C. Odouard, Mariana P. Socal","doi":"10.1001/jamapediatrics.2024.5536","DOIUrl":"https://doi.org/10.1001/jamapediatrics.2024.5536","url":null,"abstract":"This Viewpoint explores and provides policy recommendations for the Cell and Gene Therapy Access Model recently launched by the US Centers for Medicare &amp;amp; Medicaid Services (CMS), which aims to increase access to Medicaid recipiencts with rare and severe diseases.","PeriodicalId":14683,"journal":{"name":"JAMA Pediatrics","volume":"22 1","pages":""},"PeriodicalIF":26.1,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142825497","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JAMA PediatricsPub Date : 2024-12-16DOI: 10.1001/jamapediatrics.2024.4399
Nassr Nama, Ye Shen, Jeffrey N Bone, Zerlyn Lee, Kara Picco, Falla Jin, Jessica L Foulds, Josée Anne Gagnon, Chris Novak, Brigitte Parisien, Matthew Donlan, Ran D Goldman, Anupam Sehgal, Joanna Holland, Sanjay Mahant, Joel S Tieder, Peter J Gill
{"title":"External Validation of Brief Resolved Unexplained Events Prediction Rules for Serious Underlying Diagnosis.","authors":"Nassr Nama, Ye Shen, Jeffrey N Bone, Zerlyn Lee, Kara Picco, Falla Jin, Jessica L Foulds, Josée Anne Gagnon, Chris Novak, Brigitte Parisien, Matthew Donlan, Ran D Goldman, Anupam Sehgal, Joanna Holland, Sanjay Mahant, Joel S Tieder, Peter J Gill","doi":"10.1001/jamapediatrics.2024.4399","DOIUrl":"10.1001/jamapediatrics.2024.4399","url":null,"abstract":"<p><strong>Importance: </strong>The American Academy of Pediatrics (AAP) higher-risk criteria for brief resolved unexplained events (BRUE) have a low positive predictive value (4.8%) and misclassify most infants as higher risk (>90%). New BRUE prediction rules from a US cohort of 3283 infants showed improved discrimination; however, these rules have not been validated in an external cohort.</p><p><strong>Objective: </strong>To externally validate new BRUE prediction rules and compare them with the AAP higher-risk criteria.</p><p><strong>Design, setting, and participants: </strong>This was a retrospective multicenter cohort study conducted from 2017 to 2021 and monitored for 90 days after index presentation. The setting included infants younger than 1 year with a BRUE identified through retrospective chart review from 11 Canadian hospitals. Study data were analyzed from March 2022 to March 2024.</p><p><strong>Exposures: </strong>The BRUE prediction rules.</p><p><strong>Main outcome and measure: </strong>The primary outcome was a serious underlying diagnosis, defined as conditions where a delay in diagnosis could lead to increased morbidity or mortality.</p><p><strong>Results: </strong>Of 1042 patients (median [IQR] age, 41 [13-84] days; 529 female [50.8%]), 977 (93.8%) were classified as higher risk by the AAP criteria. A total of 79 patients (7.6%) had a serious underlying diagnosis. For this outcome, the AAP criteria demonstrated a sensitivity of 100.0% (95% CI, 95.4%-100.0%), a specificity of 6.7% (95% CI, 5.2%-8.5%), a positive likelihood ratio (LR+) of 1.07 (95% CI, 1.05-1.09), and an AUC of 0.53 (95% CI, 0.53-0.54). The BRUE prediction rule for discerning serious diagnoses displayed an AUC of 0.60 (95% CI, 0.54-0.67; calibration intercept: 0.60), which improved to an AUC of 0.71 (95% CI, 0.65-0.76; P < .001; calibration intercept: 0.00) after model revision. Event recurrence was noted in 163 patients (15.6%). For this outcome, the AAP criteria yielded a sensitivity of 99.4% (95% CI, 96.6%-100.0%), a specificity of 7.3% (95% CI, 5.7%-9.2%), an LR+ of 1.07 (95% CI, 1.05-1.10), and an AUC of 0.58 (95% CI, 0.56-0.58). The AUC of the prediction rule stood at 0.67 (95% CI, 0.62-0.72; calibration intercept: 0.15).</p><p><strong>Conclusions and relevance: </strong>Results of this multicenter cohort study show that the BRUE prediction rules outperformed the AAP higher-risk criteria on external geographical validation, and performance improved after recalibration. These rules provide clinicians and families with a more precise tool to support decision-making, grounded in individual risk tolerance.</p>","PeriodicalId":14683,"journal":{"name":"JAMA Pediatrics","volume":" ","pages":""},"PeriodicalIF":24.7,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142828509","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JAMA PediatricsPub Date : 2024-12-09DOI: 10.1001/jamapediatrics.2024.5361
Jessica Lee Schleider, Amanda Smock, Isaac Lev Ahuvia, Tubanji Walubita, Andy Seth Rapoport, Shannon Hill, Jonathan Purtle
{"title":"State Parental Consent Law and Treatment Use Among Adolescents With Depression","authors":"Jessica Lee Schleider, Amanda Smock, Isaac Lev Ahuvia, Tubanji Walubita, Andy Seth Rapoport, Shannon Hill, Jonathan Purtle","doi":"10.1001/jamapediatrics.2024.5361","DOIUrl":"https://doi.org/10.1001/jamapediatrics.2024.5361","url":null,"abstract":"This cross-sectional study examines the association between mental health treatment uptake and the existence of state laws prohibiting youths to consent to their own care.","PeriodicalId":14683,"journal":{"name":"JAMA Pediatrics","volume":"4 1","pages":""},"PeriodicalIF":26.1,"publicationDate":"2024-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142797112","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JAMA PediatricsPub Date : 2024-12-09DOI: 10.1001/jamapediatrics.2024.5280
Apoorva Kakkilaya, Mahnum Shahzad, Florence T. Bourgeois
{"title":"FDA Approval of Orphan Drug Indications for Pediatric Patients, 2011-2023","authors":"Apoorva Kakkilaya, Mahnum Shahzad, Florence T. Bourgeois","doi":"10.1001/jamapediatrics.2024.5280","DOIUrl":"https://doi.org/10.1001/jamapediatrics.2024.5280","url":null,"abstract":"This cohort study assesses Pediatric Research Equity Act amendments that may influence approval of orphan drug indications for pediatric patients under current regulatory programs.","PeriodicalId":14683,"journal":{"name":"JAMA Pediatrics","volume":"33 1","pages":""},"PeriodicalIF":26.1,"publicationDate":"2024-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142797110","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}