Evaluating the clinical and cost effectiveness of breathing support treatment types in infants under 12 months of age with acute bronchiolitis

Not Applicable

• Conditions: Bronchiolitis; Respiratory

• Registration Number: ISRCTN52937119
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-04
• Last Update Posted: 18 September 2023
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 1508

Inclusion Criteria

1. Hospitalised infant aged < 12 months with a clinical diagnosis of acute bronchiolitis AND
2. Clinically assessed at least twice 15 minutes apart to have EITHER:
2.1. Severe respiratory distress (respiratory rate > 70/min, or grunting, or marked chest recession) and/or recurrent short apnoeas (> 3 per hour, each apnoea lasting < 10 sec) [SEVERE BRONCHIOLITIS stratum], OR
2.2. Lack of response to LFNC oxygen up to 2 L/min, as indicated by persistent hypoxia (SpO2 < 90%, or < 92% if age < 6 weeks or if underlying health problems present) and/or moderate respiratory distress (respiratory rate 55-70/min and moderate chest recession) [MODERATE BRONCHIOLITIS stratum].

Exclusion Criteria

1. Clinical decision that patient needs immediate intubation and ventilation for life-threatening hypoxia, shock or decreased conscious level.
2. Prolonged apnoeas (> 10 seconds needing stimulation).
3. Ongoing active air leak (pneumothorax, pneumomediastinum).
4. Received HSO, HFNC or CPAP for over 2 hours in the previous 24 hours.
5. On home ventilation prior to hospital admission.
6. Tracheostomy in place.
7. Choanal atresia/stenosis, midfacial anomalies or recent craniofacial surgery.
8. Previously recruited to the BACHb trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time from randomisation to hospital discharge measured using patient records