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

Plain English summary of protocol

Background and study aims
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.

Who can participate?
Infants aged less than 12 months with moderate or severe bronchiolitis.

What does the study involve?
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.

What are the possible benefits and risks of participating?
We do not believe that there will be any direct benefit nor disadvantage to patients taking part in this study. The first treatment option that patients would have received if they were not part of the study would still have been humidified oxygen, CPAP or high-flow, but the decision would have been made by the doctor and care team instead of the study. These three treatments are being used widely across the NHS already and have all been shown to be safe. However, the information gained from patients’ participation in this study may help to improve the diagnosis and treatment of unwell children in the future. There is no monetary benefit as participants will not be paid to participate.

While the study interventions are all standard of care treatment options, the study team have considered and sought to mitigate risks that occur solely as a result of the study such as in the use of patients’ data for this research. All data will be collected, processed and stored by the study team appropriately and correctly to the highest standards of confidentiality and security. The study will comply with all relevant regulations regarding use of data and data protection. Only de-identified or pseudonymised information would be shared between study partners. All our study teams will have received training in BACHb processes and procedures and would work in accordance with the principles of Good Clinical Practice (GCP).

Where is the study run from?
Imperial College London (UK)

When is the study starting and how long is it expected to run for?
April 2023 to September 2026

Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).

Who is the main contact?
Richard Cleaver, r.cleaver@imperial.ac.uk

Study website

Contact information

Mr Richard Cleaver
Public

Imperial College London
Room 5.03
5th Floor, Medical School Building
St Mary’s Campus
Norfolk Place
London
W2 1PG
United Kingdom

Phone	+44 7999 044627
Email	r.cleaver@imperial.ac.uk

Dr Padmanabhan Ramnarayan
Principal Investigator

Imperial College London
Room 508, 5th Floor, Medical School Building
St Mary’s Campus, Norfolk Place
London
W2 1PG
United Kingdom

ORCID ID	0000-0003-0784-8154
Email	p.ramnarayan@imperial.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• Northern Ireland
• Scotland
• United Kingdom

Study participating centres

Sponsor information

Imperial College London
University/education

Faculty Building
London
SW7 2AZ
England
United Kingdom

Phone	+44 207 594 9459
Email	rgit@imperial.ac.uk
Website	http://www.imperial.ac.uk/
"ROR"	https://ror.org/041kmwe10

Funders

Funder type

Government

Results and Publications

Editorial Notes

14/08/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).