Bronchiolitis Clearance Airways With Seaserum
ConditionBronchiolitis Acute
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-1
SponsorUniversity Hospital, Brest
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Infants aged more than 1 month and less than 1 year
First episode of acute bronchiolitis
Emergency consultation
Existence of nasal obstruction
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Physiomer
DeviceInfants 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.
Saline solution
DeviceInfants 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.
Treatment groups
458 Participants
are divided into 2 treatment groupsGroup A: PhysiomerExperimental treatment 1 intervention
Group B: Saline solutionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Duration of resolution of illness (ROI)
It is the time it takes for the child to return to baseline according to the person administering the care. ROI is defined by ordinal scale from 0 to 4 on which parents globally rate symptoms according to the following categories: (1) worsened, (2) same, (3) improved, (4) resolved. The duration of ROI is the time it takes to obtain a score of 4.
Time frame
At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10Secondary outcomes
1
An again medical consultation
Parents will be given a notebook to fill in on a daily basis. For this outcome, the following question will be asked: "Have you seen a doctor today for bronchiolitis?" YES/NO
Time frame
At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 102
Hospitalization
Parents will be given a notebook to fill in on a daily basis. For this outcome, the following question will be asked: "Is your child in hospital?" YES/NO. If yes, the length of hospital stay in hours will be collected.
Time frame
At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 103
Time to improvement of cough in days
Parents will be given a notebook to fill in on a daily basis. For this outcome, the following question will be asked: "How is the cough today?", with four possible answers (1) worsened, (2) same, (3) improved, (4) resolved.
Time frame
At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 104
Time to improvement of nasal congestion in days
Parents will be given a notebook to fill in on a daily basis. For this outcome, the following question will be asked: "How are colds today??", with four possible answers (1) worsened, (2) same, (3) improved, (4) resolved.
Time frame
At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10Sponsors and contacts
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Source ClinicalTrials.gov