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Bronchiolitis Clearance Airways With Seaserum

NCT ID: NCT06177197

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

458 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-10

Study Completion Date

2028-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bronchiolitis Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

multicenter, prospective, controlled, randomized in two parallel arms, double label blind.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
neither the patient, the parents nor the investigating physician are aware of the product allocated.

Study Groups

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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.

Group Type EXPERIMENTAL

Physiomer

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Saline solution

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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Electrodilysed seawater solution

Eligibility Criteria

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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 \&amp;lt; 48 hours before emergency consultation
* Outpatient care after emergency consultation
* Mild to moderate bronchiolitis according to the \&amp;#34;Haute Autorité de Santé 2019\&amp;#34; criteria:

Respiratory rate over 1 minute \&amp;gt;30/minutes and \&amp;lt;60/minute ; Heart rate \&amp;gt;80/minutes and \&amp;lt;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 \&amp;gt;50% of the usual quantity over 3 consecutive doses; SpO2 \&amp;gt; 92% during sleep ; \&amp;gt;94% when awake; \&amp;gt;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 \&lt;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
Minimum Eligible Age

1 Month

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Brest, University Hospital

Brest, , France

Site Status RECRUITING

Le Mans hospital

Le Mans, , France

Site Status RECRUITING

Lille, University hospital

Lille, , France

Site Status NOT_YET_RECRUITING

Saint-Joseph hospital

Marseille, , France

Site Status RECRUITING

Morlaix hospital

Morlaix, , France

Site Status RECRUITING

Nantes, University Hospital

Nantes, , France

Site Status RECRUITING

Rennes, University hospital

Rennes, , France

Site Status RECRUITING

Tours, University hospital

Tours, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Pierrick CROS, MD

Role: CONTACT

[email protected]
+33298223659

Léa GAITAN, MD

Role: CONTACT

[email protected]

Facility Contacts

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Pierrick CROS, MD

Role: primary

[email protected]
02 98 22 36 59

Guillaume DEVERRIERE, MD

Role: backup

[email protected]

Aude FORGERON, MD

Role: primary

François DUBOS, MD

Role: primary

Ania CARSIN, MD

Role: primary

Thomas BRIAND, MD

Role: primary

Anne-Claire VIGUIE, MD

Role: primary

Tommasco DE GIORGIS, MD

Role: primary

Yves MAROT, MD

Role: primary

Other Identifiers

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29BRC23.0193

Identifier Type: -

Identifier Source: org_study_id