Bronchiolitis Clearance Airways With Seaserum

NCT06177197 | Recruiting

• 1 other identifier: 29BRC23.0193
• Study Type: interventional
• Target: 458
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Bronchiolitis Acute

Keywords

Infant; Nasopharyngeal decongestion; Bronchiolitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• An again medical consultation

  At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10

• Hospitalization

  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

  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

  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

  At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10

Study Arms (2)

Physiomer

EXPERIMENTAL

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

Saline solution

ACTIVE COMPARATOR

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

Interventions

Saline solution 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.

Saline solution

Physiomer 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.

Also known as: Electrodilysed seawater solution

Physiomer

Eligibility Criteria

• Age: 1 Month - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (8)

Brest, University Hospital

Brest, 29609, France

RECRUITING

Le Mans hospital

Le Mans, 72037, France

RECRUITING

Lille, University hospital

Lille, 59000, France

NOT YET RECRUITING

Saint-Joseph hospital

Marseille, 13008, France

RECRUITING

Morlaix hospital

Morlaix, 29600, France

RECRUITING

Nantes, University Hospital

Nantes, 44400, France

RECRUITING

Rennes, University hospital

Rennes, 35033, France

RECRUITING

Tours, University hospital

Tours, 37000, France

RECRUITING

MeSH Terms

Conditions

Bronchiolitis

Interventions

Abortion, Induced

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Obstetric Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Pierrick CROS, MD

CONTACT

+33298223659; pierrick.cros@chu-brest.fr

Léa GAITAN, MD

CONTACT

lea.gaitan@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: neither the patient, the parents nor the investigating physician are aware of the product allocated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: multicenter, prospective, controlled, randomized in two parallel arms, double label blind.

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 20, 2023
• Study Start: January 10, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

FR (8)