PREcision Medicine Directed Corticosteroids In Children With preSchool Wheeze

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.

Conditions

• Wheezing

Interventions

DIAGNOSTIC_TEST

Point of care respiratory virus testing

Patients to be randomised to receive OCS based on the the result of the RSV results within their respiratory virus test. This test will be performed as a point of care (POC) test in ED. This intervention will stratify the randomisation in a 1:1 ratio, to receive OCS or not. NB) Whilst the respiratory pathogen test is not routine care to determine the OCS prescription, it is frequently used within this setting. Additionally both the receipt (or not the receipt) of OCS is within standard care pathway. For the purpose of the trial OCS = Dexamethasone, which is delivered as oral suspension 300mcg/kg as per standard practice within the local Trust.

Sponsors & Collaborators

• Asthma UK

  collaborator OTHER

• Pediatric Emergency Research in the UK and Ireland (PERUKI)

  collaborator OTHER

• Queen's University, Belfast

  lead OTHER

Principal Investigators

• Helen E Groves, PhD · Queen's University, Belfast

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

24 Months

Max Age

60 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-11-04

Primary Completion

2025-11-03

Completion

2025-12-03

Countries

• United Kingdom

Study Locations