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Can salt water clear your Baby's stuffy nose? new study aims to find out

NCT ID NCT07257224

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at how well a saltwater (saline) nasal spray works and how safe it is for infants and toddlers aged 3 months to 4 years with stuffy noses from colds, flu, or allergies. About 83 children will use the spray for up to 14 days, and parents will report symptom changes. The goal is to see if it helps clear congestion and improve breathing without causing side effects.

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.

Participants

About 83 people

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

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Infants and toddlers aged 3 to 48 months, both male and female, presenting with nasal congestion associated with flu, common cold, allergic rhinitis, or rhinosinusitis, recruited from pediatric clinical practices and pediatric physiotherapy clinics.

Ages

3 to 48 months

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: * Male and female infants / toddlers aged 3 to 48 months (inclusive) at the time of enrolment. * Subjects with flu, cold, allergic rhinitis or rhinosinusitis as reported by their legal guardian(s) and/or medical history. * Subjects presenting at least moderately bothersome nasal congestion (blocked or stuffy nose) as reported by their legal guardian(s) and/or medical history and confirmed by the site investigator through non-diagnostic inspection. * Subjects suitable for nasal hygiene treatment with the study device according to its IFU. * Subjects with nasal congestion symptoms that began within 48 hours prior to enrolment. * Subjects whose legal guardian(s) signed written informed consent on their behalf to participate in the study. * Subject whose legal guardian(s) are willing and able to follow the IFU and comply with all study procedures. Exclusion Criteria (if any severe symptoms are seen in the subject, the guardian will be advised to seek medical evaluation by the subject's physician): * Subjects with known hypersensitivity or intolerance to seawater or any of its natural mineral components (e.g., sodium, chloride, magnesium) as reported by their legal guardian(s) and/or medical history. * Subjects showing severe symptoms such as persistent fever (\>38°C), severe cough, ear pain, or respiratory distress, as reported by their legal guardian(s) and/or medical history. * Subjects whose legal guardian(s) and/or medical history report any ongoing medical diagnosis or treatment for acute infection or chronic respiratory disease (e.g., asthma, pneumonia, laryngotracheobronchitis, sinusitis, etc.). * Subjects whose legal guardians(s) and/or medical history report any type of immunodeficiency. * Subjects whose legal guardian(s) and/or medical history report a neurological condition that may affect respiratory functioning. * Subjects with visible nasal injury, wounds or bleeding, or any condition that may contraindicate the use of the study device according to the device IFU. * Subjects who are currently participating or have participated in another clinical investigation within the last 30 days prior to enrolment. * Subjects using saline nasal drops or nasal sprays or pumps other than the study product within 12 hours prior to the time of enrolment or during the study. * Subjects using the study product within 24 hours prior to the time of enrolment in the study. * Subject using antibiotics, antivirals, intranasal medications, decongestants, antihistamines, mucolytics, echinacea, combination cold formulas, supplements containing ≥ 10 mg zinc that could influence symptom scores within 12 hours prior to the time of enrolment or during the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Clínica Uner

    Alicante, 03010, Spain

    Contact Email: •••••@•••••

  • Nombre de Mujer

    Alicante, 03013, Spain

    Contact Email: •••••@•••••

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