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)
File(s)
Published version
Author(s)
Type
Journal Article
Abstract
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.
DESIGN:
Pragmatic, group-sequential, two-stratum, multicenter, open-label randomized clinical trial.
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 H2O.
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.
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.
DESIGN:
Pragmatic, group-sequential, two-stratum, multicenter, open-label randomized clinical trial.
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 H2O.
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.
Date Issued
2025-10-01
Date Acceptance
2025-08-01
Citation
Pediatric Critical Care Medicine, 2025, 26 (10), pp.e1275-e1285
ISSN
1529-7535
Publisher
Lippincott, Williams & Wilkins
Start Page
e1275
End Page
e1285
Journal / Book Title
Pediatric Critical Care Medicine
Volume
26
Issue
10
Copyright Statement
Copyright © 2025 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies. This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
License URL
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/40810583
PII: 00130478-990000000-00539
Subjects
bronchiolitis
continuous positive airway pressure
high-flow nasal cannula therapy
humidified oxygen
noninvasive respiratory support
Humans
Infant
Bronchiolitis
Oxygen Inhalation Therapy
Continuous Positive Airway Pressure
Cost-Benefit Analysis
Cannula
Multicenter Studies as Topic
Acute Disease
Randomized Controlled Trials as Topic
Male
Female
Pragmatic Clinical Trials as Topic
Infant, Newborn
Publication Status
Published
Coverage Spatial
United States
Date Publish Online
2025-08-14