Using seawater to treat infant bronchiolitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 \< 48 hours before emergency consultation
* Outpatient care after emergency consultation
* Mild to moderate bronchiolitis according to the \"Haute Autorité de Santé 2019\" criteria:

Respiratory rate over 1 minute \>30/minutes and \<60/minute ; Heart rate \>80/minutes and \<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 \>50% of the usual quantity over 3 consecutive doses; SpO2 \> 92% during sleep ; \>94% when awake; \>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 it's running

• Brest, University Hospital
  Brest, France Recruiting
• Le Mans hospital
  Le Mans, France Recruiting
• Saint-Joseph hospital
  Marseille, France Recruiting
• Morlaix hospital
  Morlaix, France Recruiting
• Nantes, University Hospital
  Nantes, France Recruiting
• Rennes, University hospital
  Rennes, France Recruiting

Study contacts

• Study coordinator: Pierrick CROS, MD
• Email: pierrick.cros@chu-brest.fr
• Phone: +33298223659

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.