An interventional study of Physiomer and Saline solution in Bronchiolitis Acute, sponsored by University Hospital, Brest. Recruiting at 8 sites in France. Open to participants aged 1 Month to 1 Year. Per ClinicalTrials.gov, last updated 2025-12-17.
Sponsored by University Hospital, Brest · Not applicable, Interventional, and Treatment
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.
289 studies on the registry are indexed under Bronchiolitis; 51 are open to participants now.
This study's planned enrollment of 458 is above the median of 100 across 195 interventional studies indexed under Bronchiolitis.
Browse Bronchiolitis studies →University Hospital, Brest is the lead sponsor of 601 studies on the registry; 136 are open to participants now.
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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:
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
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
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.
Also known as: 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: * 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.
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
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.
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
Plan to share: Yes — All collected data that underlie results in a publication
Supporting information: Study protocol
Time frame: Data will be available beginning three years and ending fifteen years following the final study report completion
Access criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for Nov 2027, 33 months after the start.
Of 54 non-industry interventional studies with no phase under Bronchiolitis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 35. This study's planned 33 months is above that.
Counting every sponsor, half of 57 studies reached it within 22 months; a quarter within 11 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
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