Actively Recruiting

Phase Not Applicable
Age: 24Months - 60Months
All Genders
Healthy Volunteers
ID06580600

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

Led by Queen's University, Belfast · Updated on 2025-03-21

120

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

Q

Queen's University, Belfast

Lead Sponsor

A

Asthma UK

Collaborating Sponsor

AI-Summary

What this Trial Is About

Young children aged 24 to 60 months who visit the emergency department with wheeze often experience attacks triggered by viral infections like the common cold. This research evaluates whether using rapid point-of-care viral testing can help decide if oral corticosteroids (OCS) should be given to treat mild-to-moderate wheeze attacks in this age group. The study aims to address the uncertainty about which children benefit from steroids, as current care varies and oral steroids may have side effects. The study is a single-center, open-label, randomized feasibility trial enrolling about 60 preschool children. After enrollment, children receive a nasal swab tested for respiratory viruses, with results available within 30 minutes. Based on these results, participants are randomized to either receive oral dexamethasone (a corticosteroid) or no corticosteroid treatment, both considered standard care options. All other emergency treatments continue as usual, and if dexamethasone is given but vomited within 30 minutes, it can be re-administered. Follow-up includes a clinical review at 2 working days and a phone call at 28 days post-enrollment, with optional finger prick blood testing for eosinophil count. Participants will be monitored through study visits and phone calls to track treatment adherence, acceptability of viral testing, and clinical outcomes. Researchers will collect data on recruitment, timeliness of procedures, and viral causes of wheeze. Families may also participate in interviews to provide feedback on the study. The total study duration includes initial emergency care and follow-up over 28 days, with safety and treatment decisions guided by the treating physician.

CONDITIONS

Brief Title

PREcision Medicine Directed Corticosteroids In Children With preSchool Wheeze

Who Can Participate

Age: 24Months - 60Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 24 to 60 months inclusive
  • Clinical diagnosis of acute wheeze
  • Clinical uncertainty about the benefit of oral corticosteroids in standard care
Not Eligible

You will not qualify if you...

  • Signs or symptoms of severe or life-threatening wheeze
  • Wheeze suspected to have a non-respiratory cause
  • Evidence of shock or bacterial sepsis
  • Past severe asthma or previous intensive care admission for wheeze
  • History of preterm birth before 36 weeks gestation
  • Known immunodeficiency or ongoing immunosuppressive therapy
  • Contraindication to oral corticosteroids
  • Previous participation in this study

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person) in the Emergency Department

Treatment

Duration - Single dose administered at enrollment, with clinical management continuing as needed

Participants receive oral corticosteroids (dexamethasone) or no corticosteroids based on randomization informed by point-of-care respiratory virus testing. Standard care treatments continue as needed.

1 baseline visit (in-person) during Emergency Department presentation

Post-treatment Follow-up

Duration - 28 days post enrollment

Participants return for a clinical review and repeat nasal swab approximately 2 working days after enrollment, and receive a follow-up phone call around 28 days post-enrollment to complete study assessments.

1 in-person review visit at 2 working days post enrollment and 1 phone call at 28 days

Trial Site Locations

Total: 1 location

1

Royal Belfast Hospital for Sick Children

Belfast, NI, United Kingdom, BT12 6BA

Actively Recruiting

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Research Team

H

Hannah R Norman-Bruce, MBBS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

2

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Published Research Related To This Trial

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: a protocol.

Hannah Norman-Bruce, Clare Mills, Holly Drummond...

https://pubmed.ncbi.nlm.nih.gov/41736065