Status:
RECRUITING
PREcision Medicine Directed Corticosteroids In Children With preSchool Wheeze
Lead Sponsor:
Queen's University, Belfast
Collaborating Sponsors:
Asthma UK
Pediatric Emergency Research in the UK and Ireland (PERUKI)
Conditions:
Wheezing
Eligibility:
All Genders
24-60 years
Phase:
NA
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 ...
Detailed Description
PRECISE will be a feasibility study; conducted as a single-centre, prospective, randomised open-label study. Participants will be screened by the clinical team from attendances to the local Emergency ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 3 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06580600
Start Date
November 4 2024
End Date
December 3 2025
Last Update
March 21 2025
Active Locations (1)
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1
Royal Belfast Hospital for Sick Children
Belfast, NI, United Kingdom, BT12 6BA