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BACH-b

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

Age <12 months Bronchiolitis Oxygen delivery

Study aim

Looking at whether high-flow nasal cannula (HFNC) is more effective than humidified oxygen (moderate cases) or CPAP (severe cases) in children with bronchiolitis

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

Enrollment conflicts

  • None: Co-enrolment with observational studies is permitted without prior agreement

Step-by-step recruitment guide

Standard working hours (09:00 – 17:00)
1 Contact the ED Research Team when an eligible patient arrives in the ED — send a message via Epic chat to "ED Research Team" or phone 217907.
2 The ED Research Team will see the patient to arrange consent and randomisation.
Out of hours & weekends
X There is no out-of-hours recruitment for this study

Further information