Using targeted corticosteroids for preschool children with wheezing
A Single Centre Randomised, Feasibility Study Using Point-of-care (POC) Testing for Respiratory Viruses to Direct Oral Corticosteroids Use in Preschool-aged Children With Acute Wheeze.
This study is testing if quick virus tests can help doctors decide if preschool kids with wheezing should get corticosteroids to avoid giving them unnecessary treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 24 Months to 60 Months |
| Sex | All |
| Sponsor | Queen's University, Belfast Academic / other |
| Locations | 1 site (Belfast, NI) |
| Trial ID | NCT06580600 on ClinicalTrials.gov |
What this trial studies
This study aims to determine if point-of-care respiratory virus testing can help identify preschool children with mild-to-moderate wheeze who would benefit from corticosteroid treatment. It will involve screening children aged 24 to 60 months who present to the emergency department with acute wheeze. Eligible participants will undergo nasal swab testing for respiratory viruses, and their treatment will be guided by the results to minimize unnecessary corticosteroid use. The study will be conducted at a single center, focusing on improving treatment decisions for young children experiencing wheeze.
Who should consider this trial
Good fit: Ideal candidates are preschool children aged 24 to 60 months with a clinical diagnosis of acute wheeze and uncertainty regarding the benefit of oral corticosteroids.
Not a fit: Patients with severe wheeze, signs of shock, or contraindications to corticosteroids will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and safer treatment for preschool children with wheezing by ensuring that only those who will benefit from corticosteroids receive them.
How similar studies have performed: While there is ongoing research in this area, this specific approach using point-of-care testing for corticosteroid treatment in preschool wheeze is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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 this trial is running
Belfast, NI
- Royal Belfast Hospital for Sick Children — Belfast, Ni, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Helen E Groves, PhD — Queen's University, Belfast
- Study coordinator: Hannah R Norman-Bruce, MBBS
- Email: hnormanbruce01@qub.ac.uk
- Phone: (+44) 028 9097 1643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.