Can salt water clear your Baby's stuffy nose? new study aims to find out
NCT ID NCT07257224
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Allergic rhinitis are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
2 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
-
Contact
Email: •••••@•••••
Locations
-
Clínica Uner
Alicante, 03010, Spain
Contact Email: •••••@•••••
-
Nombre de Mujer
Alicante, 03013, Spain
Contact Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Could a daily supplement keep the common cold at bay?
- Can a needle in the face tame allergy symptoms?
- Can AI make acupuncture more precise for allergy relief?
- Ancient herbal blend put to the test against hay fever
- Can a pinpoint pollen dose unmask allergy triggers?
- Can an antihistamine–steroid combo pill beat standard allergy meds?