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Protocol for a Group-Sequential Two-Stratum Multicenter Open-Label Randomized Clinical Trial of Respiratory Support
Isabel Johnson1, Katy Bridges1, Richard Cleaver2
1Children's Clinical Research Facility, Imperial College Healthcare NHS Trust, London, United Kingdom.
Insights
This study compares high-flow nasal cannula (HFNC) therapy to standard oxygen and CPAP for infants with moderate to severe bronchiolitis. The primary outcome is hospital discharge time, assessing clinical and cost-effectiveness.
Area of Science:
- Pediatric Respiratory Medicine
- Clinical Trials
- Health Economics
Background:
- Bronchiolitis is a common respiratory infection in infants, often requiring hospitalization.
- Current treatments include standard oxygen and continuous positive airway pressure (CPAP), with varying effectiveness.
- High-flow nasal cannula (HFNC) therapy is an emerging treatment option for respiratory distress in infants.
Purpose of the Study:
- To evaluate the clinical and cost-effectiveness of HFNC compared to humidified standard oxygen (HSO) in infants with moderate bronchiolitis.
- To assess the clinical and cost-effectiveness of HFNC compared to CPAP in infants with severe bronchiolitis.
- To determine the optimal respiratory support strategy for hospitalized infants with bronchiolitis.
Main Methods:
- A pragmatic, group-sequential, two-stratum, multicenter, open-label randomized clinical trial involving 50 hospitals.
- Infants younger than 12 months with moderate or severe bronchiolitis were randomized 1:1 to HFNC or HSO/CPAP.
- The primary outcome was time from randomization to hospital discharge within 30 days; cost-effectiveness outcomes were also collected.
Main Results:
- Infants were randomized to either the moderate bronchiolitis stratum (HFNC vs. HSO) or severe bronchiolitis stratum (HFNC vs. CPAP).
- The primary outcome, time to hospital discharge, will be analyzed to determine treatment efficacy.
- Baseline characteristics and hospital course data were collected for comprehensive analysis.
Conclusions:
- The BACHb trial will provide crucial data on the effectiveness and cost-effectiveness of HFNC in pediatric bronchiolitis.
- Findings will inform clinical practice guidelines for respiratory support in infants with bronchiolitis.
- Results will be disseminated through conferences, publications, and social media to reach a wide audience.
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 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.
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