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Bronchiolitis Clearance Airways With Seaserum

RecruitingNAAges 1 Month - 1 YearAllUniversity Hospital, Brest
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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 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
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What it tests

  • Physiomer
  • Saline solution
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Where

8 sites
Brest, University Hospital
Brest, France
Le Mans hospital
Le Mans, France
Lille, University hospital
Lille, France
Saint-Joseph hospital
Marseille, France
Morlaix hospital
Morlaix, France
Nantes, University Hospital
Nantes, France
Rennes, University hospital
Rennes, France
Tours, University hospital
Tours, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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