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Bronchiolitis Clearance Airways With Seaserum

NCT06177197 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 458

Last updated 2025-12-17

No results posted yet for this study

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.

Conditions

  • Bronchiolitis Acute

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.

Sponsors & Collaborators

  • University Hospital, Brest

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-10
Primary Completion
2027-11-01
Completion
2028-12-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06177197 on ClinicalTrials.gov