NOVEMBR study v1.0
Research type
Research Study
Full title
Non-invasive ventilation for the management of children with bronchiolitis: a feasibility study.
IRAS ID
191271
Contact name
Lucy Cooper
Contact email
Sponsor organisation
Alder Hey Children's NHS Foundation Trust
Duration of Study in the UK
1 years, 6 months, days
Research summary
Research Summary:
Bronchiolitis is a very common condition that generally affects children between 0-24 months of age. Symptoms include difficulty breathing, cough and poor feeding. Most children 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 children need to go to intensive care for help with their breathing. To stop this from happening, health care professionals (HCPs)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 long term aim of this research is to find out the best way of treating breathing difficulties in children with bronchiolitis. Before we can do this we need to know if this research is possible and the proposed trial design is acceptable. We therefore intend to consult with a range of important stakeholders.We propose a study which will include:
1. Stakeholder workshops (including focus groups and consensus methods)
2. Parent interviews
Stakeholders will be considered eligible if they are parents/legal representatives of young children or HCPs who look after children with a clinical diagnosis of bronchiolitis.At the end of our study, we will be able to decide if a big trial comparing different ways of treating children with bronchiolitis in hospital with breathing difficulties is possible and needed.
Lay summary of study results:
Bronchiolitis is a very common condition that generally affects small babies. Symptoms include difficulty breathing, cough and poor feeding. Most babies are fine looked after at home but lots need to come into hospital to have oxygen.In hospital, one-in-ten babies need to go to intensive care for help with their breathing. To stop this from happening, paediatricians give oxygen through the nose either at high pressure or at high flow rates (so called non-invasive ventilation [NIV]) to open the small airways in their chests. Importantly, we don’t know which is the best way of giving oxygen to support babies breathing. Partly because of this, how and when NIV is used in the UK varies a lot, as do lengths of stay in hospital.
The aim of this research was to find out whether it would be possible to do a trial of NIV treatments and what such a trial would look like. As part of our study we surveyed in person and on-line parents of babies with bronchiolitis and healthcare professionals.
We found that most babies hospitalised with bronchiolitis are very young but are often not in hospital for very long. About half need oxygen. We found out how these NIV treatments are used currently, and that there’s a lot of interest in doing an NIV trial in the UK. We’ve agreed a list of important outcomes that should be measured in all future bronchiolitis trials (not just those on NIV). We’ve also agreed the key features of a trial of NIV in babies with bronchiolitis.
This research will be used to support applications to trial different ways of supporting breathing in children with bronchiolitis. It will also help future babies with bronchiolitis by ensuring that data from bronchiolitis trials can be more easily compared and pooled.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
16/YH/0012
Date of REC Opinion
15 Jan 2016
REC opinion
Favourable Opinion