PREcision Medicine Directed Corticosteroids In Children With preSchool Wheeze

Launched by QUEEN'S UNIVERSITY, BELFAST · Aug 29, 2024

Keywords

ClinConnect Summary

The PRECISE Study is a clinical trial designed to explore how certain viral infections in young children may affect their response to oral steroid medications during wheezing attacks. Wheezing is a common issue in preschoolers, often triggered by viruses like the common cold. While steroids can help reduce swelling in the lungs, they can also have side effects, and doctors sometimes struggle to decide which children would benefit from them. This study aims to use quick viral tests that provide results in about 30 minutes to help determine which children are more likely to respond well to these medications.

To be eligible for the study, children must be between 2 and 5 years old and have been diagnosed with acute wheezing. They should also be in a situation where it’s unclear if oral steroids would help them. However, children with severe wheezing, signs of serious illness, or certain medical histories won't be included in the study. Participants will be assessed during their visit to the emergency department and, if eligible, may receive either oral steroids or standard care. This trial will help researchers gather information to plan a larger study in the future.

Gender

ALL

Eligibility 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