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Clinical Trials in France / NCT06177197
Recruiting Not applicable

Bronchiolitis Clearance Airways With Seaserum

NCT06177197 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Brest
Phase
Not applicable
Started
2025-01-10
Last updated
2025-12-17

Condition(s) studied

Bronchiolitis Acute

Investigational drug(s) / intervention(s)

PhysiomerSaline solution

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.

Study 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.

Eligibility

Sex
ALL
Min age
1 Month
Max age
1 Year
Healthy volunteers
No
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

Primary outcome measure(s)

  • Duration of resolution of illness (ROI) — At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
    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.

Trial sites (8)

FacilityCityRegionStatus
Brest, University Hospital Brest France Recruiting
Le Mans hospital Le Mans France Recruiting
Lille, University hospital Lille France Not Yet Recruiting
Saint-Joseph hospital Marseille France Recruiting
Morlaix hospital Morlaix France Recruiting
Nantes, University Hospital Nantes France Recruiting
Rennes, University hospital Rennes France Recruiting
Tours, University hospital Tours France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06177197 on ClinicalTrials.gov ↗ ← All trials in France