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Recruiting NCT06177197

Bronchiolitis Clearance Airways With Seaserum

Trial Parameters

Condition Bronchiolitis Acute
Sponsor University Hospital, Brest
Study Type INTERVENTIONAL
Phase N/A
Enrollment 458
Sex ALL
Min Age 1 Month
Max Age 1 Year
Start Date 2025-01-10
Completion 2027-11-01
Interventions
PhysiomerSaline solution

Brief 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 Criteria

Inclusion Criteria: * Infants aged more than 1 month and less than 1 year * First episode of acute bronchiolitis * Emergency consultation * Existence of nasal obstruction * Onset of symptoms \< 48 hours before emergency consultation * Outpatient care after emergency consultation * Mild to moderate bronchiolitis according to the \"Haute Autorité de Santé 2019\" criteria: Respiratory rate over 1 minute \>30/minutes and \<60/minute ; Heart rate \>80/minutes and \<180/minutes; Absence of respiratory pauses; Absence of superficial breathing; Absence of signs of intense respiratory struggle: involvement of the lower intercostal accessory muscles, sternocleidomastoid muscles, thoracoabdominal swinging, or flapping of the wings of the nose; Feeding \>50% of the usual quantity over 3 consecutive doses; SpO2 \> 92% during sleep ; \>94% when awake; \>2 months corrected age * Parental consent * Affiliate to a social sec

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