Breathing Assistance in CHildren with bronchiolitis (BACHb): a group-sequential two-stratum multicentre open-label randomised clinical trial of respiratory support in infants with acute bronchiolitis
Eligibility
Local study conflicts
- None: Co-enrolment with observational studies is permitted without prior agreemen
Inclusion Criteria:
- Hospitalised infant aged <12 months with a clinical diagnosis of acute bronchiolitis
AND - Clinically assessed at least twice, 15 minutes apart to have lack of response to LFNC oxygen up to 2 L/min, as indicated by persistent hypoxaemia (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:
- Clinical decision that patient needs immediate intubation and ventilation for life-threatening hypoxaemia, shock or decreased conscious level.
- Prolonged apnoeas (>10 seconds needing stimulation).
- Ongoing active air leak (pneumothorax, pneumomediastinum).
- Received HSO, HFNC or CPAP for over 2 hours in the previous 24 hours.
- On home ventilation prior to hospital admission.
- Tracheostomy in place.
- Choanal atresia/stenosis, midfacial anomalies or recent craniofacial surgery.
- Previously recruited to the BACHb trial in the last 90 days
Step by Step Guide to Recruitment:
In standard working hours; 9-5
- Contact the BACHb Team via EPIC secure chat as soon as possible.
- There is no need to discuss the referral to the BACHb team with the patient before contacting them.
Out of hours and weekends:
No recruitment out of hours.