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.

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Young children frequently attend the emergency department (ED) with wheeze which is usually triggered by a virus infection, such as the common cold. Wheeze can be treated with inhaled medications and sometimes oral steroid medicines are also given to reduce swelling within the lungs. Unfortunately, oral steroids can have side effects. 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. The investigators hypothesise that in a subgroup of children with mild-to-moderate acute wheeze attacks, the viral trigger can predict their response to steroid medications. Previously, respiratory virus testing was too slow to be used to inform treatments in the ED. Now, point-of-care (POC) viral tests can provide results within 30 minutes. There is a research gap regarding the role of these tests in determining steroid responsiveness and outcomes in children presenting with acute wheeze in the pre-school population. In order to address the hypothesis in a future definitive trial, the feasibility of using (POC) viral tests to randomise steroid treatments for children in a clinical study in the ED setting must be ascertained. The PRECISE Study will therefore be a single centre randomised, feasibility study enrolling approximately 60 pre-school aged children to inform a future definitive multi-centre Randomised Controlled Trial.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 5
Healthy Volunteers: t
View:

• 24-60 months (infants from 24 months +0 days to 60 months + 0 days inclusive)

• Clinical diagnosis of acute wheeze

• Clinical uncertainty regarding the benefit of OCS as part of patient's standard care

Locations
Other Locations
United Kingdom
Royal Belfast Hospital for Sick Children
RECRUITING
Belfast
Contact Information
Primary
Hannah R Norman-Bruce, MBBS
hnormanbruce01@qub.ac.uk
(+44) 028 9097 1643
Time Frame
Start Date: 2024-11-04
Estimated Completion Date: 2025-12-03
Participants
Target number of participants: 120
Treatments
Active_comparator: OCS
To receive OCS (this is standard of care as the children will be recruited if their is clinicial uncertainty over the benefit of OCS, i.e. this is not a CTIMP). The local policy is to prescribe Dexamethasone suspension 300mcg/kg in a single dose.
No_intervention: No OCS
The child will not recieve any cortisteroid medications (this is standard of care as the children will be recruited if their is clinicial uncertainty over the benefit of OCS, i.e. this is not a CTIMP).
Related Therapeutic Areas
Sponsors
Leads: Queen's University, Belfast
Collaborators: Asthma UK, Pediatric Emergency Research in the UK and Ireland (PERUKI)

This content was sourced from clinicaltrials.gov