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

INTERVENTION: 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: Moderate bronchiolitis: Group 1 will start Humidified Standard Oxygen (HSO), and Group 2 will start High Flow Nasal Cannula (HFNC) Severe bronchiolitis: Group 1 will start Continuous Positive Airway Pressure (CPAP), and Group 2 will start HFNC To make sure it is fair, children are put into the groups at random by a computer programme so they have an equal chance of being in Group 1 or Group 2. Randomisation will be performed soon after confirming eligibility and as close as possible to the anticipated start of the randomised treatment. Randomisation will be performed using a web‐based system. If the initial breathing support treatment is not working, the trial allows doctors and nurses to change to a different treatment. The procedures/data collection schedule for patients enrolled into the trial is: BASELINE VISIT Clinical/baseline data will be collected along with details of types of breathing support received (including weaning, switches and escalations from Humidified Standard Oxygen (HSO), High Flow Nasal Cannula (HFNC), Continuous Positive Airway Pressure (CPAP)) and patient comfort (FLACC score). AT THE TIME OF CONSENT Patient/parent details will be collected in addition to Patient comfort (parent/carer reported). DURING BREATHING SUPPORT Types of breathing support received will be documented as well as patient comfort (FLACC score) and safety monitoring data throughout the patients participation in the trial. END OF HOSPITAL STAY Data will be collected on the details of the discharge aswell as and newly identified safety monitoring data. FOLLOW UP AT 30 DAYS AND 90 CONDITION: Bronchiolitis ; Respiratory PRIMARY OUTCOME: Time from randomisation to hospital discharge measured using patient records SECONDARY OUTCOME: 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 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].