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RECRUITING
NCT06177197
NA

Bronchiolitis Clearance Airways With Seaserum

Sponsor: University Hospital, Brest

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

DEVICE

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