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Bronchiolitis Clearance Airways With Seaserum
Sponsor: University Hospital, Brest
Summary
The objective of this study is to show that the use of electrodialyzed seawater reduces the duration (in days) of symptoms in acute infant bronchiolitis compared with the use of saline solution in infants aged 1 month to less than one year. B-CLASS study is a multicenter, prospective, controlled, randomized, double label blind.
Official title: Bronchiolitis Clearance Airways With Seaserum : a Doubled Blind Randomized Study
Key Details
Gender
All
Age Range
1 Month - 1 Year
Study Type
INTERVENTIONAL
Enrollment
458
Start Date
2025-01-10
Completion Date
2028-12-01
Last Updated
2025-12-17
Healthy Volunteers
No
Conditions
Interventions
Physiomer
Infants randomized to the experimental group will be given an electrolyzed seawater solution by their parents for up to 10 days. Dosage is adapted according to the child's age and discomfort: * Infant \< 6 months: half a dose to a single dose administered per nostril 8 times a day. * Infant \> 6 months: one single dose administered per nostril 6 times a day.
Saline solution
Infants randomized to the control group will be given a saline solution by their parents for up to 10 days. Dosage is adapted according to the child's age and discomfort: * Infant \< 6 months: half a dose to a single dose administered per nostril 8 times a day. * Infant \> 6 months: one single dose administered per nostril 6 times a day.
Locations (8)
Brest, University Hospital
Brest, France
Le Mans hospital
Le Mans, France
Lille, University hospital
Lille, France
Saint-Joseph hospital
Marseille, France
Morlaix hospital
Morlaix, France
Nantes, University Hospital
Nantes, France
Rennes, University hospital
Rennes, France
Tours, University hospital
Tours, France