Using seawater to treat infant bronchiolitis
Bronchiolitis Clearance Airways With Seaserum : a Doubled Blind Randomized Study
This study is testing if using electrodialyzed seawater can help reduce symptoms in infants with bronchiolitis better than regular saline solution.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 458 (estimated) |
| Ages | 1 Month to 1 Year |
| Sex | All |
| Sponsor | University Hospital, Brest Academic / other |
| Locations | 8 sites (Brest and 7 other locations) |
| Trial ID | NCT06177197 on ClinicalTrials.gov |
What this trial studies
This study aims to determine if electrodialyzed seawater can reduce the duration of symptoms in infants with acute bronchiolitis compared to saline solution. It is a multicenter, prospective, controlled, randomized, double-blind study involving infants aged 1 month to less than 1 year. Participants will be randomly assigned to receive either the experimental treatment or the control treatment, and their parents will be contacted for follow-up assessments at specified intervals after treatment. The study focuses on infants experiencing their first episode of mild to moderate bronchiolitis.
Who should consider this trial
Good fit: Ideal candidates are infants aged 1 month to less than 1 year experiencing their first episode of acute bronchiolitis with mild to moderate symptoms.
Not a fit: Patients with severe bronchiolitis or those who do not meet the inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and natural option for alleviating symptoms of bronchiolitis in infants.
How similar studies have performed: While the use of seawater in medical treatments is not widely tested, similar studies exploring alternative treatments for respiratory conditions have shown promise.
Eligibility criteria
Show full inclusion / exclusion 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 \&lt; 48 hours before emergency consultation * Outpatient care after emergency consultation * Mild to moderate bronchiolitis according to the \&#34;Haute Autorité de Santé 2019\&#34; criteria: Respiratory rate over 1 minute \&gt;30/minutes and \&lt;60/minute ; Heart rate \&gt;80/minutes and \&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 \&gt;50% of the usual quantity over 3 consecutive doses; SpO2 \&gt; 92% during sleep ; \&gt;94% when awake; \&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 \<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
Where this trial is running
Brest and 7 other locations
- 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)
Study contacts
- Study coordinator: Pierrick CROS, MD
- Email: pierrick.cros@chu-brest.fr
- Phone: +33298223659
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.