Bronchiolitis Clearance Airways With Seaserum (B-CLASS)

Bronchiolitis Clearance Airways With Seaserum : a Doubled Blind Randomized Study

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.

Study Overview

• Status: Recruiting
• Conditions: Bronchiolitis Acute
• Intervention / Treatment: Device: Physiomer; Device: Saline solution

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.

• Study Type: Interventional
• Enrollment (Estimated): 458
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Léa GAITAN, MD; Email: lea.gaitan@chu-brest.fr
• Study Contact Backup: Name: Pierrick CROS, MD; Phone Number: +33298223659; Email: pierrick.cros@chu-brest.fr

Study Locations

• France
  • Brest, France, 29609
    • Recruiting
    • Brest, University Hospital
    • Contact: Pierrick CROS, MD; Phone Number: 02 98 22 36 59; Email: pierrick.cros@chu-brest.fr
    • Contact: Guillaume DEVERRIERE, MD; Email: guillaume.deverriere@chu-brest.fr
  • Le Mans, France, 72037
    • Recruiting
    • Le Mans Hospital
    • Contact: Aude FORGERON, MD
  • Lille, France, 59000
    • Not yet recruiting
    • Lille, University hospital
    • Contact: François DUBOS, MD
  • Marseille, France, 13008
    • Recruiting
    • Saint-Joseph hospital
    • Contact: Ania CARSIN, MD
  • Morlaix, France, 29600
    • Recruiting
    • Morlaix hospital
    • Contact: Thomas BRIAND, MD
  • Nantes, France, 44400
    • Recruiting
    • Nantes, University Hospital
    • Contact: Anne-Claire VIGUIE, MD
  • Rennes, France, 35033
    • Recruiting
    • Rennes, University hospital
    • Contact: Tommasco DE GIORGIS, MD
  • Tours, France, 37000
    • Recruiting
    • Tours, University hospital
    • Contact: Yves MAROT, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physiomer; 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; 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.; Other Names: Electrodilysed seawater solution
Active Comparator: Saline solution; 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 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.

What is the study measuring?

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
Decrease of number of acute middle ear	Number of patients with an acute middle ear	At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Actual): December 20, 2023

Study Record Updates

• Last Update Posted (Estimated): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Infant; Bronchiolitis; Nasopharyngeal decongestion
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis; Surgical Procedures, Operative; Obstetric Surgical Procedures; Abortion, Induced
• Other Study ID Numbers: 29BRC23.0193

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No