NCT06177197

Bronchiolitis Clearance Airways With Seaserum

Bronchiolitis Clearance Airways With Seaserum : a Doubled Blind Randomized Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 458 (estimated)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 1 Month – 1 Year
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multicenter, prospective, controlled, randomized in 2 parrallel arms, double blind study. The Infants will be included after written informed consent will be obtained from the patients' parents or legally authorized representatives. Patients will be randomized either in the experimental group (electrodialyzed seawater) or in the control group (saline solution). Patients' parents will be call by phone at day 1, day 3, day 6, day 10 and day 21 after baseline.

Conditions

• Bronchiolitis Acute

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-10
• Primary completion: 2027-11-01
• Completion: 2028-12-01
• First posted: 2023-12-20
• Last updated: 2025-12-17

Locations

8 sites across 1 country: France