PREcision Medicine Directed Corticosteroids In Children With preSchool Wheeze

Recruiting now · Not applicable

Conditions studied: Wheezing

In brief

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.

Key facts

Study ID

NCT06580600

Run by

Queen's University, Belfast

People needed

120

Starts

2024-11-04

Expected to finish

2025-12-03

Last updated by the study team

2025-03-21

Who can join

Age: 2 and older, up to 5. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Signs and symptoms of severe or life-threatening wheeze
• Patients presenting with wheeze suspicious for a non - respiratory cause
• Clinical evidence of shock or bacterial sepsis
• Past history of severe or life-threatening asthma or history of previous PICU admission with acute wheeze
• History of preterm birth (before 36+0 weeks gestation)
• Known immunodeficiency/ongoing immunosuppressive therapy
• Contraindication to oral corticosteroids
• Previously enrolled in the PRECISE Study

Where it is running

• Royal Belfast Hospital for Sick Children — Belfast, NI, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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