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
Condition(s) studied
Investigational drug(s) / intervention(s)
Quinton Medical Nasal Health Baby®: CE-marked Class IIa isotonic seawater nasal spray intended for nasal hygiene and relief of nasal congestion in infants and toddlers. In this study, the device will be administered according to its Instructions for Use, up to 6 applications per day, for a maximum of 14 days. Participants will be evaluated at Day 2, Day 5, and Day 14 for symptom relief, nasal discharge clearance, breathing improvement, sleep quality, and safety outcomes.
Study 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.
Eligibility
Primary outcome measure(s)
- Safety - Treatment-related AEs and SAEs at Day 5 Performance - Improvement in nasal congestion improvement indicators at Day 5 — Baseline to Day 5
Safety: Occurrence of Treatment-related Adverse Events (TRAEs) and Serious Adverse Events (SAEs) at day 5 post-enrolment with daily device use as per the device Instructions for Use (IFU). Performance: Relief of nasal congestion, improvement in nasal discharge clearance and improvement of breathing at day 5 post-enrolment with daily device use as per IFU assessed by VAS (0-10) by legal guardian(s). - Functioning - Symptom improvement at Day 5 — Baseline to Day 5
Change in participant caregiver-reported symptom severity (nasal congestion, nasal discharge clearance, and breathing) using a Visual Analog Scale (VAS, 0-10) from baseline to Day 5 with daily treatment with Quinton Medical Nasal Health Baby® as per its Instructions for Use.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Clínica Uner | Alicante | Spain | |
| Nombre de Mujer | Alicante | Spain |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07257224 on ClinicalTrials.gov ↗ ← All trials in Spain