Bronchiolitis Clearance Airways With Seaserum

Study Overview
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Brief Summary
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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
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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.

Official Title
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Bronchiolitis Clearance Airways With Seaserum : a Doubled Blind Randomized Study

Conditions
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Bronchiolitis Acute

Intervention / Treatment
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* Device: Physiomer
* Device: Saline solution


Participation Criteria
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Eligibility Criteria
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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 <34 weeks of amenorrhea) History of invasive ventilation in the neonatal period History of chronic pulmonary or cardiac pathology History of immunodeficiency History of multiple disabilities or neuromuscular pathology History of Ear Nose and Throat pathology affecting the upper airways Impossibility of ensuring the follow-up made necessary by participation in this study

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: multicenter, prospective, controlled, randomized in two parallel arms, double label blind.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physiomer<br>It is a sterile, isotonic seawater-based solution, with a concentration equivalent to 9 g/L sodium chloride. This solution is packaged in 5 mL single-dose units. It is a Class IIa medical device manufactured by Laboratoire de la mer, and is CE marked. Electrodialyzed seawater solution is administered via the nasal passage, in line with current recommendations. Dosage varies according to age, and the pressure exerted on the unit dose enables the product to be administered into the nostril. | Device: Physiomer<br>* 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.<br>* Other names: Electrodilysed seawater solution;|
| Active Comparator: Saline solution<br>It is a sterile, isotonic seawater-based solution, with a concentration egal to 0,9 g/L sodium chloride. This solution is packaged in 5 mL single-dose units. It is a Class IIa medical device manufactured by GiLBERT, and is CE marked. The saline solution is administered via the nasal passage, in line with current recommendations. Dosage varies according to age, and the pressure exerted on the unit dose enables the product to be administered into the nostril. | Device: Saline solution<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | 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. | 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 | 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. | 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?. | 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. | 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 | 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. | 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. | 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. | 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. | 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. | At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant, Nasopharyngeal decongestion, Bronchiolitis