Clinical trial NCT06177197: Bronchiolitis Clearance Airways With Seaserum
Official title: Bronchiolitis Clearance Airways With Seaserum : a Doubled Blind Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bronchiolitis Acute
Keywords: Infant
Nasopharyngeal decongestion
Bronchiolitis
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2023-12-20
Enrollment: 458
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multicenter, prospective, controlled, randomized in two parallel arms, double label blind.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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 outcomes:
measure: Duration of resolution of illness (ROI)
timeFrame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
Secondary outcomes:
measure: An again medical consultation
timeFrame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
measure: Hospitalization
timeFrame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
measure: Time to improvement of cough in days
timeFrame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
measure: Time to improvement of nasal congestion in days
timeFrame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
measure: Length with nasopharyngeal decongestion in days
timeFrame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
measure: Number of nasopharyngeal decongestion by day
timeFrame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
measure: Length of dietary resumption greater than 2/3 of usual intake.
timeFrame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
measure: Antibiotic use
timeFrame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
measure: Length of community eviction en days
timeFrame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
measure: Length of parental absence from work (in days)
timeFrame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
measure: Occurrence of secondary events: epistaxis, vomiting, malaise, apnea
timeFrame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
measure: Time to improvement in respiratory discomfort in days
timeFrame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
measure: Time to improvement in sleep quality in days
timeFrame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
measure: Decrease of number of acute middle ear
timeFrame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
Other outcomes:
Locations:
city: Brest
country: France
facility: Brest, University Hospital
city: Le Mans
country: France
facility: Le Mans hospital
city: Lille
country: France
facility: Lille, University hospital
city: Marseille
country: France
facility: Saint-Joseph hospital
city: Morlaix
country: France
facility: Morlaix hospital
city: Nantes
country: France
facility: Nantes, University Hospital
city: Rennes
country: France
facility: Rennes, University hospital
city: Tours
country: France
facility: Tours, University hospital
Study officials:
References: