NCT Number: NCT06177197
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.
Interested in participating?
Request Info1 month–1 year
All sexes
Interventional
Not applicable
Brest, University Hospital, Brest, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion 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
Exclusion criteria
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:
Other names: Electrodilysed seawater 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:
Time frame: 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.
Time frame: 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
Time frame: 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 frame: 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 frame: 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.
Time frame: 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.
Time frame: 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?".
Time frame: 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".
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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 frame: 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 frame: 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.
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 patients with an acute middle ear
Contact information is provided by the study sponsor or research team.
University Hospital, Brest
Other
Bronchiolitis Clearance Airways With Seaserum : a Doubled Blind Randomized Study
Acronym: B-CLASS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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