Bronchiolitis Clearance Airways With Seaserum

Bronchiolitis Acute Clinical Trial

— B-CLASS  

Official title:

Bronchiolitis Clearance Airways With Seaserum : a Doubled Blind Randomized Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06177197
• Other study ID #: 29BRC23.0193
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: February 1, 2027

Study information

• Verified date: December 2023
• Source: University Hospital, Brest
• Contact: Pierrick CROS, MD
• Phone: 02 98 22 36 59
• Email: pierrick.cros[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 458
• Est. completion date: February 1, 2027
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 1 Year

Eligibility

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

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchiolitis Acute

Intervention

Device:
• Physiomer
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.
• Saline 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.

Locations

Country	Name	City	State
France	Brest, University Hospital	Brest
France	Le Mans hospital	Le Mans
France	Lille, University hospital	Lille
France	Saint-Joseph hospital	Marseille
France	Morlaix hospital	Morlaix
France	Nantes, University Hospital	Nantes
France	Rennes, University hospital	Rennes
France	Tours, University hospital	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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