BMJ Paediatrics Open最新文献

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Raising our game: the bare minimum every systematic review publication must meet. 提高我们的游戏:每个系统评论出版物必须满足的最低要求。
IF 2.3 4区 医学
BMJ Paediatrics Open Pub Date : 2025-09-02 DOI: 10.1136/bmjpo-2025-003717
Morris Gordon
{"title":"Raising our game: the bare minimum every systematic review publication must meet.","authors":"Morris Gordon","doi":"10.1136/bmjpo-2025-003717","DOIUrl":"10.1136/bmjpo-2025-003717","url":null,"abstract":"","PeriodicalId":9069,"journal":{"name":"BMJ Paediatrics Open","volume":"9 1","pages":""},"PeriodicalIF":2.3,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12406822/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144942312","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Parental resilience and child quality of life following paediatric hospitalisation: a prospective cohort study. 儿童住院后父母心理弹性和儿童生活质量:一项前瞻性队列研究
IF 2.3 4区 医学
BMJ Paediatrics Open Pub Date : 2025-09-02 DOI: 10.1136/bmjpo-2025-003669
Nonglak Boonchooduang, Ninlapat Jidmahawong, Supakanya Kungsuwan, Sukanlaya Seetaboot, Narueporn Likhitweerawong, Orawan Louthrenoo
{"title":"Parental resilience and child quality of life following paediatric hospitalisation: a prospective cohort study.","authors":"Nonglak Boonchooduang, Ninlapat Jidmahawong, Supakanya Kungsuwan, Sukanlaya Seetaboot, Narueporn Likhitweerawong, Orawan Louthrenoo","doi":"10.1136/bmjpo-2025-003669","DOIUrl":"10.1136/bmjpo-2025-003669","url":null,"abstract":"<p><strong>Objective: </strong>To investigate how parental resilience affects children's health-related quality of life (QoL) following hospital discharge, comparing outcomes between paediatric intensive care and general ward admissions.</p><p><strong>Design: </strong>Prospective cohort study with 2-month follow-up.</p><p><strong>Setting: </strong>Tertiary care hospital in Thailand (February 2021-August 2022).</p><p><strong>Participants: </strong>100 parent-child dyads (58 paediatric intensive care unit (PICU), 42 general ward) with children aged 4-16 years; 95% completed both assessments.</p><p><strong>Main outcome measures: </strong>Parental resilience assessed using the Resilience Quotient questionnaire and children's QoL measured using the Paediatric QoL Inventory 4.0.</p><p><strong>Results: </strong>Cross-lagged analysis revealed that baseline parental resilience significantly predicted child QoL at follow-up (β=0.426, p=0.038), but baseline child QoL did not significantly predict changes in parental resilience. Hierarchical regression identified changes in parental resilience (β=1.090, p<0.01) and baseline child QoL (β=0.524, p<0.01) as key predictors of later QoL. Parents of general ward patients showed greater improvements in resilience and their children demonstrated significant improvements in social functioning (21.67 vs 8.58 points, p=0.005) and total QoL scores (12.06 vs 4.13 points, p=0.038) compared with the PICU group.</p><p><strong>Conclusions: </strong>Parental resilience is a significant predictor of children's QoL following hospital discharge, with a unidirectional relationship where parental resilience influences subsequent child outcomes. This association persisted after controlling for demographic and clinical factors, suggesting the potential importance of psychological support for parents during their child's hospitalisation regardless of care setting. Longitudinal studies with longer follow-up periods are needed to validate these findings and assess their clinical significance.</p>","PeriodicalId":9069,"journal":{"name":"BMJ Paediatrics Open","volume":"9 1","pages":""},"PeriodicalIF":2.3,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12406887/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144942332","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
50 years of a nation-wide child development programme in India. 印度50年的全国儿童发展计划。
IF 2.3 4区 医学
BMJ Paediatrics Open Pub Date : 2025-09-02 DOI: 10.1136/bmjpo-2025-003857
Vandana Prasad
{"title":"50 years of a nation-wide child development programme in India.","authors":"Vandana Prasad","doi":"10.1136/bmjpo-2025-003857","DOIUrl":"10.1136/bmjpo-2025-003857","url":null,"abstract":"<p><p>This article reviews the current status of the Integrated Child Development Services (ICDS) Scheme, India; the largest Early Childhood Care and Development (ECCD) programme in the world, at 50 years of its existence. While there has been substantial advance of this scheme in terms of coverage and quality, its thrust has remained on providing supplementary nutrition and much more needs to be done to achieve truly universal and comprehensive ECCD services. The major issues besetting favourable outcomes relate to inadequate investments resulting in poor infrastructure, inadequately remunerated and capacitated ICDS workers and an overcentralisation resulting in a critical lack of community engagement and contextual adaptation. Social legislation is likely to be required to promote the rights of very young children through the reinvigoration of this scheme.</p>","PeriodicalId":9069,"journal":{"name":"BMJ Paediatrics Open","volume":"9 1","pages":""},"PeriodicalIF":2.3,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12406827/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144942222","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Alterations in diaphragmatic activity preceding and during intermittent hypoxaemia events in preterm infants. 早产儿间歇性低氧血症事件发生前和期间膈肌活动的改变。
IF 2.3 4区 医学
BMJ Paediatrics Open Pub Date : 2025-09-01 DOI: 10.1136/bmjpo-2025-003702
Ruud W van Leuteren, Lieke A P Arts, Fabio A Blom, Frans H de Jongh, Anton H van Kaam, G Jeroen Hutten
{"title":"Alterations in diaphragmatic activity preceding and during intermittent hypoxaemia events in preterm infants.","authors":"Ruud W van Leuteren, Lieke A P Arts, Fabio A Blom, Frans H de Jongh, Anton H van Kaam, G Jeroen Hutten","doi":"10.1136/bmjpo-2025-003702","DOIUrl":"10.1136/bmjpo-2025-003702","url":null,"abstract":"<p><strong>Objective: </strong>To assess the activity of the diaphragm using electromyography (dEMG) prior and during apnoea-induced intermittent hypoxaemia (IH) events in preterm infants DESIGN: A single-centre observational study.</p><p><strong>Setting: </strong>Neonatal intensive care unit.</p><p><strong>Patients: </strong>Preterm infants (<32 weeks of gestation) experiencing IH events with a frequency of >1/hour METHODS: Heart rate, oxygen saturation (SpO<sub>2</sub>) and dEMG were measured for 24 hours. dEMG data were processed for all IH events resulting in a SpO<sub>2</sub><80%. Events were scored by two reviewers as central, obstructive or mixed. Subsequently, minimum (dEMG<sub>min</sub>) and maximum (dEMG<sub>max</sub>) diaphragmatic activity were calculated in three time periods (5-1 min prior, 1 min prior and during the desaturation) for each event. The dEMG activity over time was also compared between the different apnoea types.</p><p><strong>Results: </strong>20 infants (gestational age 27.6±1.3 weeks) were included. A total of 591 IH events were used for analysis of which 88 (14.9%), 239 (40.4%) and 264 (44.7%) were scored as central, obstructive and mixed, respectively. In the 1 min before the actual IH, dEMG<sub>max</sub> and dEMG<sub>min</sub> dropped for central and increased for obstructive events. Central and obstructive events also differed during the actual event (dEMG<sub>min</sub> 6.1 vs 8.4 µV and dEMG<sub>max</sub> 9.4 vs 13.3 µV, both p<0.001 for central vs obstructive events). Mixed events did not show a distinct dEMG pattern.</p><p><strong>Conclusion: </strong>dEMG can detect and characterise central and obstructive apnoea before the IH event occurs, which supports development of automated detection and classification of apnoea events.</p>","PeriodicalId":9069,"journal":{"name":"BMJ Paediatrics Open","volume":"9 1","pages":""},"PeriodicalIF":2.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12406875/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144942192","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The quantified baby: real-world use of infant sleep monitoring technologies and its impact on parent mental health and medical decision-making. 量化婴儿:婴儿睡眠监测技术在现实世界中的应用及其对父母心理健康和医疗决策的影响。
IF 2.3 4区 医学
BMJ Paediatrics Open Pub Date : 2025-08-31 DOI: 10.1136/bmjpo-2025-003700
Jill A Dosso, Katelyn A Teng, Katherine T Roy, Julie M Robillard
{"title":"The quantified baby: real-world use of infant sleep monitoring technologies and its impact on parent mental health and medical decision-making.","authors":"Jill A Dosso, Katelyn A Teng, Katherine T Roy, Julie M Robillard","doi":"10.1136/bmjpo-2025-003700","DOIUrl":"10.1136/bmjpo-2025-003700","url":null,"abstract":"<p><strong>Background: </strong>Managing sleep is a challenging experience in early parenthood, and infant sleep problems are associated with negative outcomes within the family. A large market of devices to monitor infants' real-time health information during sleep has emerged, including smart cameras, under-mattress sensors and wearable devices. The impacts of these products on maternal and parental mental health and medical decision-making are poorly understood.</p><p><strong>Methods: </strong>We performed a systematic search for products detecting health data from sleeping children on the global retail platform Amazon in March 2023. A total of 11 262 unique reviews from 48 eligible products were retrieved from the USA, Canada, UK, and Australia sites and subjected to sentiment and thematic analyses to capture the characteristics of user families, contexts of device use and impacts on maternal and child health.</p><p><strong>Results: </strong>Parental anxiety and infants' high-risk medical status were cited by families as the main reasons to purchase products. When devices worked well, their use was associated with improved parental sleep quality and decreased anxiety. However, poor device performance was commonly reported and was linked to increased parental stress and anxiety and disrupted child sleep. Users reported making medical decisions based on device output. Price, privacy, and unsafe use of devices emerged as ethical issues.</p><p><strong>Conclusions: </strong>Use of a smart sleep device in the home is common and has implications for the health of both children and adults. Benefits and harms must be understood by parents and healthcare providers in order to support evidence-based decision-making around their use.</p>","PeriodicalId":9069,"journal":{"name":"BMJ Paediatrics Open","volume":"9 1","pages":""},"PeriodicalIF":2.3,"publicationDate":"2025-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12406816/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144942296","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Why do non-urgent patients present to the paediatric emergency department? 为什么非急症患者要到儿科急诊科就诊?
IF 2.3 4区 医学
BMJ Paediatrics Open Pub Date : 2025-08-31 DOI: 10.1136/bmjpo-2025-003613
Jennifer Veitch, Jamie Bentley
{"title":"Why do non-urgent patients present to the paediatric emergency department?","authors":"Jennifer Veitch, Jamie Bentley","doi":"10.1136/bmjpo-2025-003613","DOIUrl":"10.1136/bmjpo-2025-003613","url":null,"abstract":"<p><p>Non-urgent presentation to the paediatric emergency department (PED) is an underexplored area within the context of the National Health Service (NHS). Therefore, a pilot study was undertaken in the Royal Hospital for Children and Young People Edinburgh to evaluate the awareness of the unscheduled care policy within NHS Lothian and the reasons why parents/carers bring their child to the PED for non-urgent complaints. It was found that there was a general lack of awareness of the unscheduled care policy, and that non-urgent presentation was often due to inappropriate referral.</p>","PeriodicalId":9069,"journal":{"name":"BMJ Paediatrics Open","volume":"9 1","pages":""},"PeriodicalIF":2.3,"publicationDate":"2025-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12406878/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144942314","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Parental quality of life and its predictors in Jordanian families with children with cerebral palsy. 约旦脑瘫患儿家庭的父母生活质量及其预测因素
IF 2.3 4区 医学
BMJ Paediatrics Open Pub Date : 2025-08-26 DOI: 10.1136/bmjpo-2025-003462
Mohammad Al-Wardat, Husam Magableh, Khader A Almhdawi, Mohammad Yabroudi, Mohammad Etoom, Hashem Abu Tariah, Auwal Abdullahi, Nihad Almasri
{"title":"Parental quality of life and its predictors in Jordanian families with children with cerebral palsy.","authors":"Mohammad Al-Wardat, Husam Magableh, Khader A Almhdawi, Mohammad Yabroudi, Mohammad Etoom, Hashem Abu Tariah, Auwal Abdullahi, Nihad Almasri","doi":"10.1136/bmjpo-2025-003462","DOIUrl":"https://doi.org/10.1136/bmjpo-2025-003462","url":null,"abstract":"<p><strong>Background: </strong>The lifelong care responsibilities associated with cerebral palsy (CP) may place significant physical and psychological burdens on parents, which might hinder their quality of life (QOL). Despite their importance, factors affecting parents' QOL in CP cases remain understudied globally, including Jordan. This study aimed to assess the QOL of parents of children with CP and investigate its predictors.</p><p><strong>Methods: </strong>Sociodemographic factors were evaluated in this cross-sectional study for both the parents and their children with CP. The parents' QOL and musculoskeletal pain were assessed using the Beach Centre Family Quality of Life Scale (BCFQOL) and the Nordic Musculoskeletal Questionnaire. For a comprehensive assessment of psychological well-being and sleep quality, the Depression Anxiety Stress Scale and the Pittsburgh Sleep Quality Index were administered. The significant predictors of parents' QOL were determined using multivariable linear regression analysis.</p><p><strong>Results: </strong>150 parents of children with CP participated in this study. Participants reported a moderate to high overall level of satisfaction with BCFQOL. The highest satisfaction was observed in the family interaction and parenting, while the lowest was in emotional well-being. The regression model explained approximately 35% of the variance in parents' QOL (R²=0.35, F=5.568, p<0.001). Factors significantly predicting higher levels of parents' QOL were absence of child mental health symptoms (β=0.176 (95% CI 0.611 to 9.340), p=0.026), parents who are not smokers (β=0.2 (95% CI 1.468 to 11.608), p=0.012) and parents who do not report pain in the past 12 months (β=0.184 (95% CI 1.038 to 12.303), p=0.021).</p><p><strong>Conclusions: </strong>Parents of children with CP showed acceptable levels of QOL. A higher level of QOL was associated with the absence of child mental health symptoms, and parents who are not smokers or do not report pain. The findings highlight the need for mental health interventions, healthier habits and musculoskeletal pain management to improve parents' well-being.</p>","PeriodicalId":9069,"journal":{"name":"BMJ Paediatrics Open","volume":"9 1","pages":""},"PeriodicalIF":2.3,"publicationDate":"2025-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12382584/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144942300","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
How babies sleep: demedicalising and humanising the issue for child health professionals. 婴儿如何睡眠:儿童健康专业人员对这个问题的非医学化和人性化。
IF 2.3 4区 医学
BMJ Paediatrics Open Pub Date : 2025-08-25 DOI: 10.1136/bmjpo-2025-003760
Guddi Singh
{"title":"How babies sleep: demedicalising and humanising the issue for child health professionals.","authors":"Guddi Singh","doi":"10.1136/bmjpo-2025-003760","DOIUrl":"https://doi.org/10.1136/bmjpo-2025-003760","url":null,"abstract":"","PeriodicalId":9069,"journal":{"name":"BMJ Paediatrics Open","volume":"9 1","pages":""},"PeriodicalIF":2.3,"publicationDate":"2025-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12382545/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144942293","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Needs and experiences of families after a sudden unexplained death in childhood: a qualitative study. 儿童期不明原因突然死亡后家庭的需求和经历:一项定性研究。
IF 2.3 4区 医学
BMJ Paediatrics Open Pub Date : 2025-08-24 DOI: 10.1136/bmjpo-2025-003812
Emily Cooper, Jonathan Holmes, Nikki Speed, Joanna Jane Garstang
{"title":"Needs and experiences of families after a sudden unexplained death in childhood: a qualitative study.","authors":"Emily Cooper, Jonathan Holmes, Nikki Speed, Joanna Jane Garstang","doi":"10.1136/bmjpo-2025-003812","DOIUrl":"https://doi.org/10.1136/bmjpo-2025-003812","url":null,"abstract":"<p><strong>Background: </strong>Sudden unexplained death in childhood (SUDC) is a rare and devastating experience for families. In the UK, multi-agency investigation by police, health and social care of sudden, unexpected child deaths is a statutory requirement aiming to identify full causes for deaths. Families should be allocated bereavement keyworkers for support throughout the investigative process which can take several months. Previous research has focused on multi-agency investigation of sudden infant deaths, with little known about parents' experiences for deaths of older children.</p><p><strong>Methods: </strong>Bereaved parents of children in the UK, aged 1 to 17 years who died from SUDC during 2018-2022, were recruited through SUDC-UK charity and their mailing list and word of mouth. Semi-structured interviews were conducted in 2023. Interview transcripts underwent thematic analysis.</p><p><strong>Results: </strong>Interviews were conducted with parents from 20 families across England, Scotland and Northern Ireland in 2023. Four key themes were identified: the importance of keyworkers, trauma-informed communication, proactivity from professionals and provision of medical screening for families. Keyworkers were valued by parents, but only 12/20 families had keyworkers allocated. Communication and language were important; families were often distressed by unexpected telephone calls particularly relating to post-mortem results. Parents felt they had to be proactive explaining about SUDC to professionals who lacked knowledge of the condition. Parents wanted medical screening to be proactively offered for their families.</p><p><strong>Conclusions: </strong>Every family must receive swift, proactive, knowledgeable communication from professionals, during and beyond the investigation into their child's sudden unexpected death. This will help them through the process and mitigate the impact of poor communication on their grief. While all parents expressed that they wanted to find out why their child died, they also identified key improvements to the consistency and effectiveness of the investigation process.</p>","PeriodicalId":9069,"journal":{"name":"BMJ Paediatrics Open","volume":"9 1","pages":""},"PeriodicalIF":2.3,"publicationDate":"2025-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12382542/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144942329","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Safety and feasibility trial protocol of metformin in infants after perinatal brain injury. 二甲双胍在围产儿脑损伤后应用的安全性和可行性研究方案。
IF 2.3 4区 医学
BMJ Paediatrics Open Pub Date : 2025-08-24 DOI: 10.1136/bmjpo-2024-002784
Anne-Marie Hutchinson, Rosanna Pais, Andrea N Endginton, Betsy Pilon, Jordan M MacDonald, Mallory E MacDonald, Tamorah Lewis, Martin Offringa, Brian Thomas Kalish
{"title":"Safety and feasibility trial protocol of metformin in infants after perinatal brain injury.","authors":"Anne-Marie Hutchinson, Rosanna Pais, Andrea N Endginton, Betsy Pilon, Jordan M MacDonald, Mallory E MacDonald, Tamorah Lewis, Martin Offringa, Brian Thomas Kalish","doi":"10.1136/bmjpo-2024-002784","DOIUrl":"https://doi.org/10.1136/bmjpo-2024-002784","url":null,"abstract":"<p><strong>Introduction: </strong>Infants with hypoxic-ischaemic encephalopathy (HIE) are at a high risk for neurodevelopmental impairment, and adjunctive treatments to promote brain repair are needed. The antidiabetic drug metformin has recently been recognised as a neurorestorative agent, but, to date, has not been used in infants. Herein, we describe a clinical trial of the safety, feasibility and pharmacokinetics of metformin in infants with HIE.  METHODS AND ANALYSIS: In collaboration with patient and family stakeholders, we designed a pragmatic clinical trial. To determine appropriate dosing of metformin, we performed physiologically based pharmacokinetic (PBPK) modelling after scaling a published adult PBPK model of metformin to an infant population of full-term newborns to 3-month-olds. Based on this PBPK modelling and target drug exposure, we determined an optimal target dose of 32 mg/kg/day. Trial participants will complete baseline bloodwork and then receive 3 weeks of metformin at 25% of the target dose, followed by 3 weeks of metformin at 50% of the target dose. At a mid-study (6 week) visit, repeat laboratory testing will be done, followed by an additional 6 weeks of metformin at target dosing. The final study visit will include repeat labs following therapy at target dosing. At-home blood glucose monitoring will be used between study visits. Pharmacokinetics of metformin will be evaluated with bloodwork collected at study visits. The incidence of safety events and feasibility measures will be reported using descriptive statistics. Our infant PBPK model will be validated with study samples and the dose for future trials adjusted based on new knowledge about metformin PK in infants.</p><p><strong>Ethics and dissemination: </strong>Approval of the Boston Children's Hospital Research Ethics Committee will be obtained prior to study initiation. Trial oversight will be under the direction of a Data Safety Monitoring Board.</p><p><strong>Trial registration number: </strong>This study has been registered at www.</p><p><strong>Clinicaltrials: </strong>gov under NCT06429007.</p>","PeriodicalId":9069,"journal":{"name":"BMJ Paediatrics Open","volume":"9 1","pages":""},"PeriodicalIF":2.3,"publicationDate":"2025-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12382569/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144942282","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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