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).

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 ch

SUBMITTER: Johnson I 

PROVIDER: S-EPMC12502951 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature