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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

NCT07257224 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 83

Last updated 2025-12-02

No results posted yet for this 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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Laboratoires Quinton International S.L.

    lead INDUSTRY

Eligibility

Min Age
3 Months
Max Age
48 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2026-10-31
Completion
2026-11-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07257224 on ClinicalTrials.gov