Status:
RECRUITING
Bronchiolitis Clearance Airways With Seaserum
Lead Sponsor:
University Hospital, Brest
Conditions:
Bronchiolitis Acute
Eligibility:
All Genders
1-1 years
Phase:
NA
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 inf...
Detailed Description
This is a multicenter, prospective, controlled, randomized in 2 parrallel arms, double blind study. The Infants will be included after written informed consent will be obtained from the patients' pare...
Eligibility Criteria
Inclusion
- 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 security system
Exclusion
- 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
Key Trial Info
Start Date :
January 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
458 Patients enrolled
Trial Details
Trial ID
NCT06177197
Start Date
January 10 2025
End Date
December 1 2028
Last Update
December 17 2025
Active Locations (8)
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1
Brest, University Hospital
Brest, France, 29609
2
Le Mans hospital
Le Mans, France, 72037
3
Lille, University hospital
Lille, France, 59000
4
Saint-Joseph hospital
Marseille, France, 13008