BACHb
Research type
Research Study
Full title
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
IRAS ID
327621
Contact name
Padmanabhan Ramnarayan
Contact email
Sponsor organisation
Imperial College, London
Duration of Study in the UK
3 years, 0 months, 30 days
Research summary
Nearly 30,000 infants under one are admitted to hospitals in England each year with bronchiolitis, a common viral chest infection. Half of them need oxygen treatment through ‘nasal cannula’ (thin tubes inserted into the nostrils). Most infants respond to nasal cannula oxygen alone, but some need additional breathing support. In these infants, different treatments such as ‘humidified’ (moist) standard oxygen (HSO), high-flow nasal cannula (HFNC) and ‘CPAP’ (pressurised oxygen delivered through the nose) are used. However, it is not clear which of these treatments should be started and when.
HFNC, which provides warm, humidified oxygen at high flow rates, has become a popular breathing support treatment in bronchiolitis, and has mostly replaced the use of HSO in moderately ill infants. HFNC is also used in many hospitals as an alternative to CPAP in severe bronchiolitis. There is little research to show whether HFNC is better than HSO or CPAP. Since HFNC requires specialist equipment, it is more expensive and requires expert nursing resources. There is also concern HFNC may prolong hospital stay.
For this research, we will conduct two clinical trials at the same time to determine the effectiveness of HFNC. Infants with moderate bronchiolitis will be randomly allocated to start either HFNC or HSO, and infants with severe bronchiolitis HFNC or CPAP. All other treatment decisions will be left to the clinical team.
We will recruit 1508 infants (924 moderate and 584 severe bronchiolitis) over a 30-month period from children’s emergency departments and wards in 50 NHS hospitals. We will compare the treatments by measuring how quickly infants are discharged from hospital. We will also study other important outcomes such as patient comfort and parent/carer satisfaction. Our findings will inform national and international guidelines on the care of infants with bronchiolitis.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
23/YH/0166
Date of REC Opinion
3 Aug 2023
REC opinion
Favourable Opinion