Study of Electrodialyzed Seawater Versus Saline Solution to Reduce Symptoms of Acute Bronchiolitis in Infants Under One Year

What this Trial Is About

Researchers are evaluating whether electrodialyzed seawater can reduce the length of symptoms in infants with acute bronchiolitis compared to saline solution. This is a multicenter, prospective, randomized, double-blind study involving infants aged 1 month to less than 1 year. The study aims to measure how quickly illness resolves in these young patients. Infants will be randomly assigned to receive either the experimental electrodialyzed seawater solution or a control saline solution. Both treatments are sterile, isotonic seawater-based medical devices administered through the nose. Dosage varies by age, with infants under 6 months receiving up to 8 doses per day and those over 6 months receiving up to 6 doses per day. Parents will administer the treatments for up to 10 days. During the study, parents will be contacted by phone at days 1, 3, 6, 10, and 21 after starting treatment to monitor progress. The main outcome measured is the duration of illness resolution over the first 10 days. Secondary outcomes include cough improvement, nasal congestion, respiratory discomfort, sleep quality, hospitalizations, antibiotic use, and other health-related factors. The study will continue to monitor participants until December 2028.

Bronchiolitis Clearance Airways With Seaserum