Bronchiolitis Acute
Conditions
Keywords
Infant, Nasopharyngeal decongestion, Bronchiolitis
Brief summary
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
DEVICEPhysiomer
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.
DEVICESaline 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.
Sponsors
University Hospital, Brest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
neither the patient, the parents nor the investigating physician are aware of the product allocated.
Intervention model description
multicenter, prospective, controlled, randomized in two parallel arms, double label blind.
Eligibility
Sex/Gender
ALL
Age
1 Months to 1 Years
Healthy volunteers
No
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 <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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of resolution of illness (ROI) | At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization | At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10 | 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 to improvement of cough in days | At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10 | 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 to improvement of nasal congestion in days | At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10 | 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. |
| Length with nasopharyngeal decongestion in days | At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10 | 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. |
| Number of nasopharyngeal decongestion by day | At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10 | 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?. |
| Length of dietary resumption greater than 2/3 of usual intake. | At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10 | 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. |
| An again medical consultation | At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10 | 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 |
| Length of community eviction en days | At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10 | 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. |
| Length of parental absence from work (in days) | At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10 | 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. |
| Occurrence of secondary events: epistaxis, vomiting, malaise, apnea | At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10 | 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 to improvement in respiratory discomfort in days | At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10 | 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 to improvement in sleep quality in days | At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10 | 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. |
| Decrease of number of acute middle ear | At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10 | Number of patients with an acute middle ear |
| Antibiotic use | At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10 | 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 |
Countries
France
Contacts
Primary ContactPierrick CROS, MD
Backup ContactLéa GAITAN, MD
Outcome results
None listed