Clinical Trial

Isotonic Saline for Children With Bronchiolitis

Not Yet Recruiting
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Record status
This record was last updated June 15, 2023 (before its estimated September 2024 completion). Its status may not reflect the trial's current state.
Summary
The goal of this randomized clinical trial is to investigate the optimal supportive treatment of bronchiolitis in infants from 0-12 months of age. The main question\[s\] it aims to answer are: * To investigate whether isotonic saline should be used as supportive treatment for children with bronchiolitis, and if so, identify the optimal route of administration. The primary outcome is duration of hospitalization. * To investigate the current epidemiology of the viral pathogens causing bronchitis in children in Denmark, and to assess whether children infected with specific pathogens might benefit from treatment with isotonic saline. The children are randomized after inclusion through computer randomization to one of the 3 arms in the study: 1. Nebulized isotonic saline 2. Nasal irrigation with isotonic saline 3. No treatment with saline The investigators will compare treatment with saline (both methods) with no treatment, and the investigators will also compare the two methods of delivery of saline (nebulized vs. nasal irrigation).
Trial Details
NCT Number NCT05902702
Lead Sponsor Slagelse Hospital
Collaborators: Copenhagen University Hospital at Herlev, Zealand University Hospital, Copenhagen University Hospital, Hvidovre, Holbaek Sygehus, Nordsjaellands Hospital, Nykøbing Falster Hospital
Conditions Bronchiolitis, Respiratory Disease, Asthma in Children, Viral Infection, Acute Respiratory Infection
Enrollment 300 participants
Start Date 2023-09
Primary Completion 2024-09 (estimated)
Study Completion 2029-09 (estimated)
Updated on ClinicalTrials.gov 2023-06-15