SWISH Pilot Study v1.1
Research type
Research Study
Full title
Randomised control trial comparing high flow weaning strategies for infants with bronchiolitis: Pilot study
IRAS ID
268661
Contact name
Martin Edwards
Contact email
Sponsor organisation
Cardiff & Vale University Health Board
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
https://register.clinicaltrials.gov/, CardiffNHS record 19/OCT/7769
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Research Summary
Bronchiolitis is a common type of chest infection that tends to affect babies and young children under a year old. The symptoms of bronchiolitis start like those of a common cold. It then affects the bronchioles which are the smaller breathing tubes in the lungs. They produce more mucus than usual and become swollen, leading to a cough and a runny nose. In more severe cases, the tubes become clogged up with mucus which causes breathing problems.
Around 2 in 100 infants with bronchiolitis will need to spend some time in hospital during the course of their illness. This is usually for one of two reasons: they need oxygen treatment to keep their oxygen saturations within acceptable levels or they cannot manage to feed from the breast or a bottle because of a blocked nose or difficulty breathing.
Here at the Children’s Hospital for Wales we are using ‘High flow’ to deliver oxygen. This is a relatively new concept on the general paediatric wards, and more established in a setting such as High Dependency Unit (HDU). However, we have been using it successfully on the wards for the last 3 years.Research has shown that the early use of high flow can reduce the chances of the child needing escalation of care to a high dependency unit or paediatric intensive care unit.
We are interested in studying the process of weaning high flow support once the child is over the worst of their illness. This will enable us to use the most effective method of weaning babies from their high flow, and ready for discharge. This has the potential to reduce the number of hours spent in hospital for babies and their parents or guardians.
Summary of Results
Bronchiolitis is a common viral chest infection affecting infants and young children. Some infants with bronchiolitis require support with high-flow nasal cannula (HFNC) therapy, which delivers warmed oxygen and air through small tubes placed in the nose to help breathing.This pilot study compared two different methods of reducing (also known as ‘weaning’) HFNC support in infants admitted to hospital with bronchiolitis. One group remained on HFNC alone during weaning, while the second group was transitioned from HFNC to standard low-flow oxygen therapy (the most common method for delivering oxygen via the nose).
The study aimed to determine whether conducting a larger randomised controlled trial would be feasible and safe. We found that recruitment, randomisation, and protocol delivery were achievable if we made some minor amendments to how we would run the trial.
Infants in the HFNC-only weaning group had a longer hospital stay and took longer to return to oral feeding compared with infants transitioned to low-flow oxygen therapy. There was no difference in the duration of length of time oxygen was required between the two groups.
One infant required admission to the paediatric intensive care unit due to bacterial chest infection; however, this event was not caused by the weaning.
As this was a small pilot study, the results should be interpreted cautiously. A larger multicentre study is needed to determine the safest and most effective method for weaning HFNC therapy in infants with bronchiolitis. With small changes, this pilot study could be scaled up to be a larger, study conducted across multiple hospitals.
REC name
Wales REC 1
REC reference
20/WA/0205
Date of REC Opinion
8 Sep 2020
REC opinion
Further Information Favourable Opinion