Clinical Trial

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

Study acronym: Nasal Baby
Not Yet Recruiting
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Summary
The goal of this observational post-market clinical follow-up study is to evaluate the safety and performance of the CE-marked nasal spray in the management of nasal congestion in case of flu, colds, allergic rhinitis and rhinosinusitis in infants and toddlers aged 3 to 48 months at day 5 post-enrolment. Enrolment does not require establishing a medical diagnosis; eligibility is based on guardian-reported nasal congestion consistent with lay use of the device. Participants will be: * Evaluated by a healthcare professional for eligibility. * Receive treatment with the CE-marked nasal spray according to its Instructions for Use, for up to 14 days. * Have their legal guardians report symptom severity and improvement using standardized scales (Visual Analog Scale) during follow-up visits on Day 2, Day 5, and Day 14 and device usability on Day 14. This study does not include a comparison group and reflects real-world use of the device in routine pediatric care.
Trial Details
NCT Number NCT07257224
Lead Sponsor Laboratoires Quinton International S.L.
Conditions Nasal Congestion, Common Cold, Allergic Rhinitis, Rhinosinusitis, Flu Symptom
Enrollment 83 participants
Start Date 2025-12
Primary Completion 2026-10 (estimated)
Study Completion 2026-11 (estimated)
Updated on ClinicalTrials.gov 2025-12-02