RecruitingNot ApplicableNCT06177197

Bronchiolitis Clearance Airways With Seaserum

Bronchiolitis Clearance Airways With Seaserum : a Doubled Blind Randomized Study


Sponsor

University Hospital, Brest

Enrollment

458 participants

Start Date

Jan 10, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 MonthMax Age: 1 Year

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Physiomer and a medical device called Saline solution for people with bronchiolitis acute. The study is currently recruiting participants at 8 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPhysiomer

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.

DEVICESaline 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

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NCT06177197


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