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New treatment option for Bronchiolitis Acute
Official title Bronchiolitis Clearance Airways With Seaserum
ClinicalTrials.gov ID: NCT06177197
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 1
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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 \ 80/minutes and \ 50% of the usual quantity over 3 consecutive doses; SpO2 \>...
- Parental consent
- Affiliate to a social security system
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Brest, France
- Le Mans, France
- Lille, France
- Marseille, France
- Morlaix, France
- Nantes, France
- Rennes, France
- Tours, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 month to 1 year. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brest, France; Le Mans, France; Lille, France; Marseille, France; Morlaix, France; Nantes, France and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.