NCT07257224

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 83 (estimated)
• Sponsor: Laboratoires Quinton International S.L. · Industry
• Sex: All
• Age: 3 Months – 48 Months
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, observational, post-market clinical follow-up (PMCF) study designed to collect real-world data on the safety and performance of an isotonic seawater 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. The device is CE-marked as a Class IIa medical device under MDR 2017/745 and is already commercially available. Therefore, no investigational assignment or randomization is required. Participants will use the marketed device according to its Instructions for Use. The study will enroll children who meet defined inclusion and exclusion criteria and whose legal guardians provide informed consent. Follow-up assessments are scheduled at Day 2, Day 5, and Day 14, with the primary evaluation point at Day 5. Legal guardians will report outcomes such as nasal congestion relief, secretion clearance, and breathing improvement using validated Visual Analog Scales (VAS). Safety data, including adverse events, will be collected throughout the 14-day period. The primary objective is to confirm short-term safety and performance at Day 5. Secondary objectives include assessing sustained effects and safety through Day 14, subject legal guardian's satisfaction, and impact on sleep quality. This study is being conducted at two centers in Spain and is expected to recruit over a 10-month period, with a total study duration of approximately 11 months. Results will provide additional clinical evidence to support the continued safe and effective use of isotonic seawater nasal sprays in paediatric patients.

Conditions

• Nasal Congestion
• Common Cold
• Allergic Rhinitis
• Rhinosinusitis
• Flu Symptom

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-10-01
• Completion: 2026-11-01
• First posted: 2025-12-02
• Last updated: 2025-12-02

Locations

2 sites across 1 country: Spain