An observational study in Nasal Congestion, Common Cold and Allergic Rhinitis, sponsored by Laboratoires Quinton International S.L.. Not yet recruiting at 2 sites in Spain. Open to participants aged 6 Months to 48 Months. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Laboratoires Quinton International S.L. · Observational
The goal of this observational post-market clinical follow-up study is to evaluate the safety and performance of the CE-marked nasal spray for the relief of nasal congestion in infants and toddlers aged 6 to 48 months at day 5 post-enrollment. Enrollment 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:
This study does not include a comparison group and reflects real-world use of the device in routine pediatric care.
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 for the relief of nasal congestion in infants and toddlers aged 6 to 48 months at day 5 post-enrollment.
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.
173 studies on the registry are indexed under Nasal Obstruction; 31 are open to participants now.
This study's planned enrollment of 83 is close to the median of 80 across 25 observational studies indexed under Nasal Obstruction.
Browse Nasal Obstruction studies →This is the only study on the registry with Laboratoires Quinton International S.L. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 13, 2026. See what changed
Male and female infants / toddlers aged 6 to 48 months with nasal congestion, as reported by their legal guardian(s), identified during routine consultations in specialized physiotherapy clinics.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria :
If any severe symptoms are seen in the subject, the guardian will be advised to seek medical evaluation by the subject's physician.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Male and female infants / toddlers aged 6 to 48 months with nasal congestion, as reported by their legal guardian(s), identified during routine consultations in specialized physiotherapy clinics. All participants will use the CE-marked nasal spray according to its Instructions for Use.
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.
Safety - Treatment-related AEs and SAEs at Day 5 Performance - Improvement in nasal congestion improvement indicators at 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).
Time frame: Baseline to Day 5
Functioning - Symptom improvement at 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 the nasal spray as per its Instructions for Use.
Time frame: Baseline to Day 5
Safety - AEs, TRAEs, and SAEs up to Day 14
Number and proportion of participants experiencing any adverse events (AEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs) during the 14-day study period.
Time frame: Baseline to Day 14
Functioning - Symptom improvement and participant guardian-reported outcomes up to Day 14
Change in participant guardian-reported symptom severity (nasal congestion, secretion clearance, and breathing) at Days 2, and 14 compared to baseline using VAS (0-10); time to onset of perceived symptom relief; frequency of analgesic use; improvement of sleep quality at Days 2, 5 and 14 compared to baseline; and guardian's satisfaction at Day 14 using a 7-point Likert scale.
Time frame: Baseline to Day 14
Plan to share: No — The sponsor does not plan to share individual participant data with other or external researchers. All data will be pseudonymised and assigned a study-specific code before being entered into an electronic data collection system. Each site will have access only to the data of participants recruited at their own centre.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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