NCT06177197 Bronchiolitis Clearance Airways With Seaserum
| NCT ID | NCT06177197 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Brest |
| Condition | Bronchiolitis Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 458 participants |
| Start Date | 2025-01-10 |
| Primary Completion | 2027-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 458 participants in total. It began in 2025-01-10 with a primary completion date of 2027-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 \&lt; 48 hours before emergency consultation * Outpatient care after emergency consultation * Mild to moderate bronchiolitis according to the \&#34;Haute Autorité de Santé 2019\&#34; criteria: Respiratory rate over 1 minute \&gt;30/minutes and \&lt;60/minute ; Heart rate \&gt;80/minutes and \&lt;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 \&gt;50% of the usual quantity over 3 consecutive doses; SpO2 \&gt; 92% during sleep ; \&gt;94% when awake; \&gt;2 months corrected age * Parental consent * Affiliate to a social security system Exclusion Criteria: * Hospitalization (excluding short stay unit) after emergency consultation * Oxygen therapy * History of prematurity (birth \<36 weeks of amenorrhea) * History of invasive ventilation in the neonatal period * History of chronic pulmonary or cardiac pathology * History of immune deficiency * History of polyhandicap or neuromuscular pathology * History of malformative Ear Nose and Throat pathology affecting the upper airways * Impossibility of ensuring the follow-up made necessary by participation in this study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06177197 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 1 Year, studying Bronchiolitis Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06177197 currently recruiting?
Yes, NCT06177197 is actively recruiting participants. Contact the research team at pierrick.cros@chu-brest.fr for enrollment information.
Where is the NCT06177197 trial being conducted?
This trial is being conducted at Brest, France, Le Mans, France, Lille, France, Marseille, France and 4 additional locations.
Who is sponsoring the NCT06177197 clinical trial?
NCT06177197 is sponsored by University Hospital, Brest. The trial plans to enroll 458 participants.