Phase 4Not yet recruiting
Prevent Wheeze Trial (PRE-WHEE)
Single Dose Dexamethasone for the Prevention of Recurrent Wheeze in at Risk Children With First Episode LRTI: a Multi-country RCT in Two Low- and Middle-income Countries.
- Sponsor
- Norwegian University of Science and Technology (Academic or other)
- Enrolment
- 486 planned
- Conditions
- Lower Respiratory Tract Infection (LRTI); Recurrent Wheezing
- Interventions
- Dexamethasone 0.6 mg/kilogram body weight single dose; Placebo
- Ages
- children
- Registry
- NCT07858773
From the registry
This trial investigates whether a single dose of dexamethasone will prevent recurrent wheezing in children at high-risk for asthma admitted to hospital with a lower respiratory tract infection (LRTI). Eligible children will be identified and enrolled upon hospital admission or during hospitalisation and allocated to receive either dexamethasone 0.6 mg/kilogram body weight or the similar number of placebo tablets (allocation ratio 1:1). The follow-up is 12 months and comprises scheduled on-site examinations by physician and study nurse, scheduled phone contacts, and registrations of new LRTI-episodes (if any). Nasopharyngeal swabs and blood will be collected at specified visits. The children will be invited to a follow-up study at school age for lung function assessments.
Primary outcomes
- New episode of wheeze within 12 months from inclusion, yes/no.