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 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)
Exclusion Criteria:
Clinical decision that patient needs immediate intubation and ventilation for life-threatening hypoxaemia, shock or decreased conscious level.