Actively Recruiting
Bronchiolitis Clearance Airways With Seaserum
Led by University Hospital, Brest · Updated on 2025-12-17
458
Participants Needed
8
Research Sites
203 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Bronchiolitis Clearance Airways With Seaserum
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants aged more than 1 month and less than 1 year
- First episode of acute bronchiolitis
- Emergency consultation
- Presence of nasal obstruction
- Symptoms started less than 48 hours before emergency consultation
- Outpatient care after emergency consultation
- Mild to moderate bronchiolitis based on specific respiratory rate, heart rate, absence of severe respiratory signs, feeding above 50% of usual quantity, and oxygen saturation above thresholds
- Parental consent obtained
- Affiliated with a social security system
You will not qualify if you...
- Hospitalization (excluding short stay unit) after emergency consultation
- Oxygen therapy
- History of prematurity (birth before 36 weeks of amenorrhea)
- History of invasive ventilation in the neonatal period
- History of chronic pulmonary or cardiac disease
- History of immune deficiency
- History of severe neuromuscular or polyhandicap conditions
- History of malformative Ear Nose and Throat pathology affecting upper airways
- Inability to ensure follow-up required by study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Brest, University Hospital
Brest, France, 29609
Actively Recruiting
2
Le Mans hospital
Le Mans, France, 72037
Actively Recruiting
3
Lille, University hospital
Lille, France, 59000
Not Yet Recruiting
4
Saint-Joseph hospital
Marseille, France, 13008
Actively Recruiting
5
Morlaix hospital
Morlaix, France, 29600
Actively Recruiting
6
Nantes, University Hospital
Nantes, France, 44400
Actively Recruiting
7
Rennes, University hospital
Rennes, France, 35033
Actively Recruiting
8
Tours, University hospital
Tours, France, 37000
Actively Recruiting
Research Team
P
Pierrick CROS, MD
CONTACT
L
Léa GAITAN, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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