Bronchiolitis Respiratory
Conditions
Interventions
BACHb is a randomised clinical trial – this means children eligible for the study, depending on whether they have moderate or severe bronchiolitis, will be randomly put into one of two groups:
Moderat
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Hospitalised infant aged 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
Exclusion criteria: 1. Clinical decision that the 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from randomisation to hospital discharge measured using patient records | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured using patient records to end of hospital stay (unless noted otherwise) 1. Proportion of infants experiencing treatment failure 2. Mortality at hospital discharge, day 30 and day 90 3. Proportion of infants requiring intubation and ventilation 4. Proportion of infants requiring admission to an intensive care unit 5. Proportion of infants requiring sedation 6. Duration of oxygen therapy, defined as the time to being free from supplemental oxygen for >4 hours 7. Time to adequate (75%) oral feeding 8. Time ready for hospital discharge, defined as the time from randomisation to latest of time to being free of supplemental oxygen or adequate oral feeding. 9. Patient comfort, assessed by the caregiver using the FLACC scale. 10. Patient comfort, assessed by the parent/guardian using a visual analogue scale 11. Proportion of infants requiring hospital readmission within 30 days 12. Health status at 30 and 90 days 13. Cost-effectiveness expressed in terms of incremental cost per quality-adjusted life year (QALY) gained | — |
Countries
England, Northern Ireland, Scotland, United Kingdom
Contacts
Public ContactRichard Cleaver
Outcome results
None listed