Bronchiolitis Clearance Airways With Seaserum (B-CLASS)

Regional University Hospital Center (CHRU)

Status: Enrolling

Conditions: Bronchiolitis Acute

Treatments: Device: Physiomer; Device: Saline solution

Study type: Interventional

Funder types: Other

Identifiers

NCT06177197

29BRC23.0193

Details and patient eligibility

About

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.

Full 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.

Enrollment: 458 estimated patients

Sex: All

Ages: 1 month to 1 year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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458 participants in 2 patient groups

Physiomer

Experimental group

Description:

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.

Treatment:

Device: Physiomer

Saline solution

Active Comparator group

Description:

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.

Treatment:

Device: Saline solution