Isabel Johnson, Katy Bridges, Richard Cleaver, Rayka Malek, Mary Cross, Steve Cunningham, Katrina Cathie, Mark D Lyttle, Rebecca Mitting, Paul Mouncey, Damian Roland, Stephen Turner, Olu Onyimadu, Stavros Petrou, Debra Quantrill, Kate Chadwick, Leila Janani, Padmanabhan Ramnarayan
{"title":"急性毛细支气管炎婴儿呼吸支持组序双层多中心开放标签随机临床试验方案：毛细支气管炎儿童呼吸辅助（BACHb）","authors":"Isabel Johnson, Katy Bridges, Richard Cleaver, Rayka Malek, Mary Cross, Steve Cunningham, Katrina Cathie, Mark D Lyttle, Rebecca Mitting, Paul Mouncey, Damian Roland, Stephen Turner, Olu Onyimadu, Stavros Petrou, Debra Quantrill, Kate Chadwick, Leila Janani, Padmanabhan Ramnarayan","doi":"10.1097/PCC.0000000000003813","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>The Breathing Assistance in Children with bronchiolitis (BACHb) trial aims to evaluate the clinical and cost-effectiveness of high-flow nasal cannula (HFNC) therapy compared with humidified standard oxygen (HSO) in infants with moderate bronchiolitis, and HFNC with continuous positive airway pressure (CPAP) in severe bronchiolitis.</p><p><strong>Design: </strong>Pragmatic, group-sequential, two-stratum, multicenter, open-label randomized clinical trial.</p><p><strong>Setting: </strong>Fifty hospitals across England, Scotland, and Wales.</p><p><strong>Patients: </strong>Hospitalized infants younger than 12 months old with a clinical diagnosis of bronchiolitis, assessed at least twice 15 minutes apart to fulfill criteria for either severe bronchiolitis (one or more of: respiratory rate > 70 breaths/min, grunting, marked chest recession, recurrent short apneas) or moderate bronchiolitis (lack of response to low-flow oxygen, indicated by persistent hypoxemia and/or moderate respiratory distress).</p><p><strong>Interventions: </strong>\"Moderate bronchiolitis stratum\": HFNC at a flow rate of 2 L/kg/min vs. HSO through a facemask or headbox at a flow rate up to 15 L/min. \"Severe bronchiolitis stratum\": HFNC at a flow rate of 2 L/kg/min vs. CPAP pressure set at 6-8 cm H 2 O.</p><p><strong>Measurements and main results: </strong>In each stratum, eligible infants will be randomly allocated on a 1:1 basis to the trial treatments using a web-based system by permuted block randomization, stratified by site of recruitment and age (< 6 wk and ≥ 6 wk). Due to the emergency nature of the treatments, written informed consent will be deferred. The primary outcome is time from randomization to hospital discharge within 30 days. Baseline clinical characteristics and hospital course, including details of respiratory support, and discharge and cost-effectiveness outcomes will be collected. The trial received Health Research Authority and Research Ethics Committee approval from the Yorkshire and The Humber-South Yorkshire Research Ethics Committee on August 3, 2023 (reference: 23/YH/0166). The trial registration is ISRCTN52937119.</p><p><strong>Conclusions: </strong>Trial findings will be disseminated in national and international conferences, in peer-reviewed journals and through social media.</p>","PeriodicalId":19760,"journal":{"name":"Pediatric Critical Care Medicine","volume":" ","pages":"e1275-e1285"},"PeriodicalIF":4.5000,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12502951/pdf/","citationCount":"0","resultStr":"{\"title\":\"Protocol for a Group-Sequential Two-Stratum Multicenter Open-Label Randomized Clinical Trial of Respiratory Support in Infants With Acute Bronchiolitis: Breathing Assistance in Children With Bronchiolitis (BACHb).\",\"authors\":\"Isabel Johnson, Katy Bridges, Richard Cleaver, Rayka Malek, Mary Cross, Steve Cunningham, Katrina Cathie, Mark D Lyttle, Rebecca Mitting, Paul Mouncey, Damian Roland, Stephen Turner, Olu Onyimadu, Stavros Petrou, Debra Quantrill, Kate Chadwick, Leila Janani, Padmanabhan Ramnarayan\",\"doi\":\"10.1097/PCC.0000000000003813\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>The Breathing Assistance in Children with bronchiolitis (BACHb) trial aims to evaluate the clinical and cost-effectiveness of high-flow nasal cannula (HFNC) therapy compared with humidified standard oxygen (HSO) in infants with moderate bronchiolitis, and HFNC with continuous positive airway pressure (CPAP) in severe bronchiolitis.</p><p><strong>Design: </strong>Pragmatic, group-sequential, two-stratum, multicenter, open-label randomized clinical trial.</p><p><strong>Setting: </strong>Fifty hospitals across England, Scotland, and Wales.</p><p><strong>Patients: </strong>Hospitalized infants younger than 12 months old with a clinical diagnosis of bronchiolitis, assessed at least twice 15 minutes apart to fulfill criteria for either severe bronchiolitis (one or more of: respiratory rate > 70 breaths/min, grunting, marked chest recession, recurrent short apneas) or moderate bronchiolitis (lack of response to low-flow oxygen, indicated by persistent hypoxemia and/or moderate respiratory distress).</p><p><strong>Interventions: </strong>\\\"Moderate bronchiolitis stratum\\\": HFNC at a flow rate of 2 L/kg/min vs. HSO through a facemask or headbox at a flow rate up to 15 L/min. \\\"Severe bronchiolitis stratum\\\": HFNC at a flow rate of 2 L/kg/min vs. CPAP pressure set at 6-8 cm H 2 O.</p><p><strong>Measurements and main results: </strong>In each stratum, eligible infants will be randomly allocated on a 1:1 basis to the trial treatments using a web-based system by permuted block randomization, stratified by site of recruitment and age (< 6 wk and ≥ 6 wk). 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引用次数: 0
摘要
目的：儿童毛细支气管炎呼吸辅助（BACHb）试验旨在评估高流量鼻插管（HFNC）治疗中度毛细支气管炎的临床和成本效益，与湿化标准氧（HSO）治疗中度毛细支气管炎的婴儿，以及HFNC联合持续气道正压通气（CPAP）治疗重度毛细支气管炎的临床和成本效益。设计：实用、组序、两层、多中心、开放标签随机临床试验。环境：横跨英格兰、苏格兰和威尔士的50家医院。患者：小于12个月的住院婴儿，临床诊断为细支气管炎，间隔至少15分钟评估两次，以满足严重细支气管炎（呼吸频率bbb70次/分，咕噜声，明显胸部萎缩，复发性短呼吸暂停中的一项或多项）或中度细支气管炎（低流量氧缺乏反应，表现为持续低氧血症和/或中度呼吸窘迫）的标准。干预措施：“中度细支气管炎地层”：HFNC流速为2l /kg/min vs. HSO通过面罩或头箱流速高达15l /min。“重度细支气管炎地层”：HFNC流速为2l /kg/min， CPAP压力为6- 8cm H2O。测量结果和主要结果：在每个阶层中，符合条件的婴儿将使用基于网络的系统，按招募地点和年龄（< 6周和≥6周）按1:1的比例随机分配到试验治疗中。由于治疗的紧急性质，书面知情同意将被推迟。主要终点是从随机分组到30天内出院的时间。基线临床特征和住院过程，包括呼吸支持的细节，出院和成本效益结果将被收集。该试验于2023年8月3日获得了约克郡和亨伯-南约克郡研究伦理委员会的卫生研究管理局和研究伦理委员会的批准（参考文献：23/YH/0166）。试验注册号为ISRCTN52937119。结论：试验结果将在国内和国际会议、同行评议期刊和社交媒体上传播。
Protocol for a Group-Sequential Two-Stratum Multicenter Open-Label Randomized Clinical Trial of Respiratory Support in Infants With Acute Bronchiolitis: Breathing Assistance in Children With Bronchiolitis (BACHb).
Objectives: The Breathing Assistance in Children with bronchiolitis (BACHb) trial aims to evaluate the clinical and cost-effectiveness of high-flow nasal cannula (HFNC) therapy compared with humidified standard oxygen (HSO) in infants with moderate bronchiolitis, and HFNC with continuous positive airway pressure (CPAP) in severe bronchiolitis.
Setting: Fifty hospitals across England, Scotland, and Wales.
Patients: Hospitalized infants younger than 12 months old with a clinical diagnosis of bronchiolitis, assessed at least twice 15 minutes apart to fulfill criteria for either severe bronchiolitis (one or more of: respiratory rate > 70 breaths/min, grunting, marked chest recession, recurrent short apneas) or moderate bronchiolitis (lack of response to low-flow oxygen, indicated by persistent hypoxemia and/or moderate respiratory distress).
Interventions: "Moderate bronchiolitis stratum": HFNC at a flow rate of 2 L/kg/min vs. HSO through a facemask or headbox at a flow rate up to 15 L/min. "Severe bronchiolitis stratum": HFNC at a flow rate of 2 L/kg/min vs. CPAP pressure set at 6-8 cm H 2 O.
Measurements and main results: In each stratum, eligible infants will be randomly allocated on a 1:1 basis to the trial treatments using a web-based system by permuted block randomization, stratified by site of recruitment and age (< 6 wk and ≥ 6 wk). Due to the emergency nature of the treatments, written informed consent will be deferred. The primary outcome is time from randomization to hospital discharge within 30 days. Baseline clinical characteristics and hospital course, including details of respiratory support, and discharge and cost-effectiveness outcomes will be collected. The trial received Health Research Authority and Research Ethics Committee approval from the Yorkshire and The Humber-South Yorkshire Research Ethics Committee on August 3, 2023 (reference: 23/YH/0166). The trial registration is ISRCTN52937119.
Conclusions: Trial findings will be disseminated in national and international conferences, in peer-reviewed journals and through social media.
期刊介绍：
Pediatric Critical Care Medicine is written for the entire critical care team: pediatricians, neonatologists, respiratory therapists, nurses, and others who deal with pediatric patients who are critically ill or injured. International in scope, with editorial board members and contributors from around the world, the Journal includes a full range of scientific content, including clinical articles, scientific investigations, solicited reviews, and abstracts from pediatric critical care meetings. Additionally, the Journal includes abstracts of selected articles published in Chinese, French, Italian, Japanese, Portuguese, and Spanish translations - making news of advances in the field available to pediatric and neonatal intensive care practitioners worldwide.
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