PREcision Medicine Directed Corticosteroids In Children With preSchool Wheeze

NCT06580600 | Recruiting

• 1 other identifier: B24/01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

pre-school; wheeze; corticosteroid; point-of-care

Outcome Measures

Primary Outcomes (4)

• Recruitment

  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.

  Screening Log completed through study completion, (estimated < 1 year)

• Adherance

  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.

  measured at visit 2 and at 28 days post enrolment per patient. Throughout study completion, (estimated < 1 year)

• Timeliness

  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)

  Timeliness measured on CRFs throughout study completion, (estimated < 1 year)

• Acceptability

  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.

  Collected at 2 and 28 days post enrolment per patient. Data collected through study completion, (estimated < 1 year))

Secondary Outcomes (6)

• viral aetiology

  Through study completion, (estimated < 1 year)

• Concordance of test results

  Between enrolment and the second visit. (Throughout study completion, (estimated < 1 year))

• Acceptability of tests to formulate plan

  Data collected within one month of enrolment. Throughout study completion, (estimated < 1 year)

• Acceptability of tests to be repeated in study

  Data collected within one month of enrolment. Throughout study completion, (estimated < 1 year)

• Airway immune response

  Analysis to be performed within 1 year of study closure.

Study Arms (2)

OCS

ACTIVE COMPARATOR

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.

Diagnostic Test: Point of care respiratory virus testing

No OCS

NO INTERVENTION

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).

Interventions

Point of care respiratory virus testing DIAGNOSTIC_TEST

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.

Also known as: RSV test

OCS

Eligibility Criteria

• Age: 24 Months - 60 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• Queen's University, Belfast: lead
• Asthma UK: collaborator
• Pediatric Emergency Research in the UK and Ireland (PERUKI): collaborator

Study Sites (1)

Royal Belfast Hospital for Sick Children

Belfast, NI, BT12 6BA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Respiratory Sounds

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Helen E Groves, PhD

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah R Norman-Bruce, MBBS

CONTACT

(+44) 028 9097 1643; hnormanbruce01@qub.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Lecturer in Paediatrics

Model Details: randomised (1:1) to receive OCS or No OCS (both of which are standard of care)

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 30, 2024
• Study Start: November 4, 2024
• Primary Completion: November 3, 2025
• Study Completion: December 3, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)