PRECISE STUDY
Research type
Research Study
Full title
A single centre randomised, feasibility study using point-of-care (POC) testing for respiratory viruses to direct oral corticosteroids use in preschool-aged children with acute wheeze.
IRAS ID
336653
Contact name
Tom Waterfield
Contact email
Sponsor organisation
Queen's University Belfast
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
R&D PHA HSCNI, EAT/5732/22
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Young children frequently attend the emergency department (ED) with a wheeze attack, usually triggered by a virus infection. Wheeze can be treated with inhaled medications to relieve tightness in the chest. Additionally, oral steroid medicines are used to reduce swelling within the lungs. Unfortunately, oral steroids have side effects. They affect a child’s behaviour, sleep and can have negative effects on growth and the child’s immune system. Despite lots of research there is no clear evidence that oral steroids work in young children with a wheeze attack. It is likely that some children get better quicker with oral steroids but deciding who to treat is difficult. This results in differences in care with some children receiving unnecessary oral steroids and others not receiving them when they could benefit.
One of the commonest viral infection triggers for wheeze in young children is a common-cold virus known as Respiratory Syncytial Virus (RSV). Evidence suggests that these children may not need oral steroids. Previously, viral tests were too slow to be used to inform treatments in the ED, but now rapid viral tests can provide results within 30 minutes. This virus result may help clinicians to decide which children need to have oral steroid medications or not.
We will conduct a small study in Belfast to inform the design of a much larger UK study. The aim of our smaller, “feasibility” study is to 1) test if rapid virus tests can be performed quickly in the ED in order to randomise children to receive steroids or not; 2) confirm clinicians and families find this acceptable. We hope to show this research is important, safe and possible to do in a much larger study. Ultimately, we want to know whether or not oral steroids can help in young children with a wheeze attack.
REC name
HSC REC A
REC reference
24/NI/0050
Date of REC Opinion
12 Jun 2024
REC opinion
Further Information Favourable Opinion