Brief 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

Intervention / Treatment

• Diagnostic Test: Point of care respiratory virus testing

Primary Outcome Measures

• Recruitment (Screening Log completed through study completion, (estimated < 1 year))
  Reporting the proportion of eligible patients that are enrolled in the PRECISE Study following screening Reporting all reasons for not screening enrolling any eligible patients.
• Adherance (measured at visit 2 and at 28 days post enrolment per patient. Throughout study completion, (estimated < 1 year))
  Reporting the proportion of randomised patients remaining in allocated treatment arm. I.e. how many patients randomised to NOT recieve OCS have received them within 28 days of enrolment.
• Timeliness (Timeliness measured on CRFs throughout study completion, (estimated < 1 year))
  The time (minutes) for i) triage to clinician decision regarding eligibility to enrolment ii) screening until availability of POC test results iii) screening to documented time of randomisation iv) screening to documented time of OCS administration (if applicable)
• Acceptability (Collected at 2 and 28 days post enrolment per patient. Data collected through study completion, (estimated < 1 year)))
  Description of parent/guardian feedback on how acceptable the process of being enrolled and randomised in the study was. This includes a description of perceived barriers to future definitive trial collected from families.

Countries

United Kingdom

Locations and Investigators

• Royal Belfast Hospital for Sick Children, Belfast, United Kingdom (Recruiting)
  • Hannah Norman - Bruce, MBBS
  • Tom Waterfield, PhD (Principal Investigator)

Study Officials

• Helen E Groves, PhD (Principal Investigator) — Queen's University, Belfast