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Sea spray might soothe sick Babies' breathing

NCT ID NCT06177197

Symptom relief Sponsor: University Hospital, Brest Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a nose spray made from treated seawater can shorten the time babies (1 month to 1 year) have symptoms of bronchiolitis, compared to a standard saltwater spray. About 458 infants with their first, mild-to-moderate bout of bronchiolitis will take part. Parents will track symptoms daily to see which spray works better.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 458 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 month to 1 year

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute bronchiolitis bronchiolitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bronchiolitis acute

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Brest, University Hospital

    RECRUITING

    Brest, 29609, France

  • Le Mans hospital

    RECRUITING

    Le Mans, 72037, France

  • Lille, University hospital

    NOT_YET_RECRUITING

    Lille, 59000, France

  • Morlaix hospital

    RECRUITING

    Morlaix, 29600, France

  • Nantes, University Hospital

    RECRUITING

    Nantes, 44400, France

  • Rennes, University hospital

    RECRUITING

    Rennes, 35033, France

  • Saint-Joseph hospital

    RECRUITING

    Marseille, 13008, France

  • Tours, University hospital

    RECRUITING

    Tours, 37000, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.