Bronchiolitis Clearance Airways With Seaserum
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Physiomer, Saline solution.
- Who it may be relevant to
- Registry conditions: Bronchiolitis Acute. Basic parameters: 1 months — 1 year · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Bronchiolitis Clearance Airways With Seaserum : a Doubled Blind Randomized Study
Overview
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.
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' parents or legally authorized representatives. Patients will be randomized either in the experimental group (electrodialyzed seawater) or in the control group (saline solution).
Patients' parents will be call by phone at day 1, day 3, day 6, day 10 and day 21 after baseline.
Interventions
- Device Physiomer
Infants randomized to the experimental group will be given an electrolyzed seawater solution by their parents for up to 10 days. Dosage is adapted according to the child's age and discomfort: * Infant \< 6 months: half a dose to a single dose administered per nostril 8 times a day. * Infant \> 6 months: one single dose administered per nostril 6 times a day. - Device Saline solution
Infants randomized to the control group will be given a saline solution by their parents for up to 10 days. Dosage is adapted according to the child's age and discomfort: * Infant \< 6 months: half a dose to a single dose administered per nostril 8 times a day. * Infant \> 6 months: one single dose administered per nostril 6 times a day.
Primary outcome measures
- Duration of resolution of illness (ROI) [Time frame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10]
Secondary outcome measures (12)
- An again medical consultation [Time frame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10]
- Hospitalization [Time frame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10]
- Time to improvement of cough in days [Time frame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10]
- Time to improvement of nasal congestion in days [Time frame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10]
- Length with nasopharyngeal decongestion in days [Time frame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10]
- Number of nasopharyngeal decongestion by day [Time frame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10]
- Length of dietary resumption greater than 2/3 of usual intake. [Time frame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10]
- Antibiotic use [Time frame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10]
- Length of community eviction en days [Time frame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10]
- Length of parental absence from work (in days) [Time frame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10]
- Occurrence of secondary events: epistaxis, vomiting, malaise, apnea [Time frame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10]
- Time to improvement in respiratory discomfort in days [Time frame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10]
Eligibility criteria
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 \&lt; 48 hours before emergency consultation
- Outpatient care after emergency consultation
- Mild to moderate bronchiolitis according to the \&#34;Haute Autorité de Santé 2019\&#34; criteria:
Respiratory rate over 1 minute \&gt;30/minutes and \&lt;60/minute ; Heart rate \&gt;80/minutes and \&lt;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 \&gt;50% of the usual quantity over 3 consecutive doses; SpO2 \&gt; 92% during sleep ; \&gt;94% when awake; \&gt;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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
France · 8 centers
- Brest, University Hospital — Brest
- Le Mans hospital — Le Mans
- Lille, University hospital — Lille
- Saint-Joseph hospital — Marseille
- Morlaix hospital — Morlaix
- Nantes, University Hospital — Nantes
- Rennes, University hospital — Rennes
- Tours, University hospital — Tours
Identifiers
NCT: NCT06177197 · 29BRC23.0193