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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
458
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.
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.
Brest, University Hospital
Brest, France
RECRUITINGLe Mans hospital
Le Mans, France
RECRUITINGLille, University hospital
Lille, France
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 10
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 10
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 10
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 10
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 10
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Saint-Joseph hospital
Marseille, France
RECRUITINGMorlaix hospital
Morlaix, France
RECRUITINGNantes, University Hospital
Nantes, France
RECRUITINGRennes, University hospital
Rennes, France
RECRUITINGTours, University hospital
Tours, France
RECRUITINGLength with nasopharyngeal decongestion 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 many nasopharyngeal decongestion did you make today?". The duration of nasopharyngeal decongestion is the time it takes to obtain a score of 0.
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
Parents will be given a notebook to fill in on a daily basis. For this outcome, the following question will be asked: "How many nasopharyngeal decongestion did you make today?".
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.
Parents will be given a notebook to fill in on a daily basis. For this outcome, the following question will be asked: "How does your child eat today?". Two responses are possible : More than two-thirds, less than two-thirds. The duration of dietary resumption greater than 2/3 of usual intake is the number of days until the response is "More than half".
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
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 taking antibiotics?". YES/NO
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
Parents will be given a notebook to fill in on a daily basis. For this outcome, the following question will be asked: "Did your child have to be looked after today?". YES/NO. The duration of community eviction is the time to the child doesn't need to be looked after anymore.
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)
Parents will be given a notebook to fill in on a daily basis. For this outcome, the following question will be asked: "Did you have to miss work today?". YES/NO. The duration of parental absence is the number of day until that parent returns to work.
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
Parents will be given a notebook to fill in on a daily basis. For this outcome, the following question will be asked: "Have you noticed any side effects from nasopharyngeal decongestion?". YES/NO.
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
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 suffering from respiratory problems 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 10
Time to improvement in sleep quality 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 do you rate the quality of your child's sleep?", 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 10
Decrease of number of acute middle ear
Number of patients with an acute middle ear
Time frame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10