Title: A study to determine the feasibility of undertaking a trial on the use of non-invasive ventilation in the management of infants with bronchiolitis
Funder: Department of Health and Social Care

Abstract: In the UK, acute bronchiolitis is the most common cause of hospitalisation in infancy. Over 17,000 babies are admitted to hospital in England with this condition every winter[8]. Oxygen (O2) is the only treatment that has made a significant difference to survival over the last 40 years[8,9]. Over the last two decades, using non-invasive ventilation (NIV) support (with nasal continuous positive airway pressure (nCPAP) and high flow nasal cannula (HFNC)) to administer O2 nasally has become part of the routine clinical management of infants with severe bronchiolitis. This is despite limited evidence to support its use[7,19]. The goal of this study is to determine whether it is feasible to undertake a clinical trial to establish whether earlier use of nCPAP or HFNC O2 at lower respiratory distress thresholds is more effective at preventing progression to mechanical ventilation, and more cost effective. As NIHR have already acknowledged through their commissioned call, before such a trial can be considered, a feasibility study is needed. This feasibility study will encompass: 1. A national survey of HCPs and prospective screening log covering: a) Current practice including criteria for starting nCPAP/HFNC, proportion of patients with bronchiolitis receiving nCPAP/HFNC, and weaning criteria b) Capability including proportion of Good Clinical Practice trained nursing/medical staff, out-of-hours consultant/research nurse cover, and number of HDU beds (occupancy, staffing ratios etc.) c) Acceptability in broad terms of clinical trial on use of nCPAP/HFNC in bronchiolitis 2. The design of an intervention study for the early initiation of NIV (nCPAP/HFNC) in infants with bronchiolitis based upon: a) Stakeholder Workshops HCP Workshop will cover aspects of trial design including type and timing of intervention, respiratory threshold criteria, barriers to recruitment etc. Parent workshop will cover issues regarding consent and the acceptability of trial including potential barriers to participation in a larger study, how potential barriers should be addressed, acceptability of deferred consent, and views on patient information. Parents will also be given the option of telephone or face-to-face interviews. b) Delphi process for HCPs (general paediatricians, nurses, intensivists etc.) and parents to further refine study design. 3. The development of Core Outcome Set (COS) for clinical trials in bronchiolitis: A key limitation identified by systematic reviews on bronchiolitis treatments has been outcome heterogeneity reported in clinical trials[22]. As part of this feasibilty study, we will develop a COS to enable rational choice of primary outcome for all future trials on treatments for bronchiolitis. COS development will be acheived through: a) Systematic review of literature b) Stakeholder Consultation i. Stakeholder Workshops HCP Workshop to identify important outcome measures. Four workshops are planned with good national coverage. Parent workshop to identify outcome measures. Telephone interviews will be available to those unable to attend. Parents of children with various co-morbidities (Chronic lung disease/Cardiac disease/Downs syndrome) will be included in both. ii. Delphi process of parents and HCPs to achieve consensus on the COS c) Consensus Meeting Representative Delphi participants will be invited to take part in a consensus meeting to discuss the proposed COS. 4. Preliminary work on Health Economic (HE) assessment incorporating a literature review of methods of assessing health outcomes for economic evaluations in infants and young children. Decision on whether to proceed to a full trial Toward the end of the study, a study advisory group (SAG) will be convened, comprising health care professionals and parents who have already participated in one or more components of the study. Members of the SAG will be invited to attend a face-to-face meeting where there will be opportunity for discuss and revise a proposed study design, and to decide whether to proceed to a full trial.

Lay abstract: Bronchiolitis is a very common condition that generally affects babies less than 12 months of age. Symptoms include difficulty breathing, cough and poor feeding. Most babies can be looked after at home but many (approximately three-per-hundred of all UK infants) need to come into hospital to have oxygen. In hospital, one-in-ten infants need to go to intensive care for help with their breathing. To stop this from happening, paediatricians give treatments to open up the small airways within their chests. They do this by giving oxygen through the nose either at high pressure or at high flow rates. Importantly, we don t know which of these ways of giving oxygen is best or even if they work at all. We also don't know whether giving oxygen at high pressure or high flow rates would work better if done earlier in the illness. Partly because of this, how and when these treatments are used in the UK varies a lot, as do lengths of stay in hospital. The longterm aim of this research is to find out the best way of treating breathing difficulties in infants with bronchiolitis. Before we can do this we need to know if this research is possible. Our study will include a national survey of healthcare professionals, and will collect information on the number of infants admitted to hospital. We will also run a series of workshops and an online survey for healthcare professionals and parents to discuss opinions on treatment and to find out which outcomes of treatment are most important. We will also look at the cost of each treatment. At the end of our study, we will be able to decide if a big trial comparing different ways of treating babies with bronchiolitis in hospital with breathing difficulties is possible and warranted.

Research activity codes: 6.7 PHYSICAL
Health categories: RESPIRATORY