Post-market Clinical Follow-up Study of an Isotonic Saline Solution to Manage Nasal Congestion in Case of Flu Symptoms, Colds, Allergic Rhinitis and Rhinosinusitis in Infants and Toddlers

Exclusion Criteria

• •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.