Actively Recruiting
Bronchiolitis Clearance Airways With Seaserum: a Double Blind Randomized Study
Led by University Hospital, Brest · Updated on 2025-12-17
458
Participants Needed
8
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether electrodialyzed seawater can reduce the length of symptoms in infants with acute bronchiolitis compared to saline solution. This is a multicenter, prospective, randomized, double-blind study involving infants aged 1 month to less than 1 year. The study aims to measure how quickly illness resolves in these young patients. Infants will be randomly assigned to receive either the experimental electrodialyzed seawater solution or a control saline solution. Both treatments are sterile, isotonic seawater-based medical devices administered through the nose. Dosage varies by age, with infants under 6 months receiving up to 8 doses per day and those over 6 months receiving up to 6 doses per day. Parents will administer the treatments for up to 10 days. During the study, parents will be contacted by phone at days 1, 3, 6, 10, and 21 after starting treatment to monitor progress. The main outcome measured is the duration of illness resolution over the first 10 days. Secondary outcomes include cough improvement, nasal congestion, respiratory discomfort, sleep quality, hospitalizations, antibiotic use, and other health-related factors. The study will continue to monitor participants until December 2028.
CONDITIONS
Brief 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 and heart rate criteria
- Feeding greater than 50% of usual quantity over 3 consecutive doses
- Oxygen saturation greater than 92% during sleep and greater than 94% when awake
- Corrected age over 2 months
- Parental consent obtained
- Affiliated to 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 pathology
- History of immune deficiency
- History of severe neurological or neuromuscular disorders
- History of malformative Ear Nose and Throat pathology affecting upper airways
- Inability to ensure necessary follow-up for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 days
Participants receive a nasal solution administered by their parents for up to 10 days. Dosage is adapted according to the infant's age and discomfort, with multiple daily administrations.
Phone calls on Day 1, Day 3, Day 6, Day 10, and Day 21 after baseline
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
L
Léa GAITAN, MD
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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