[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612718":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":30,"responsibleParty":64,"collaborators":10,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":10,"studyType":79,"phases":10,"briefSummary":80,"conditions":81,"keywords":87,"overallStatus":95,"whyStopped":10,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Laboratoires Quinton International S.L.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Pediatric Nasal Congestion Cohort",null,"Infants and toddlers (3 to 48 months) with nasal congestion due to flu, colds, allergic rhinitis, or rhinosinusitis. All participants will use the CE-marked nasal spray according to its Instructions for Use.",[13],"Device: Quinton Medical Nasal Health Baby®",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"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.",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Ana Brotons Cantó, PhD","CONTACT","+34 681 216 183","ana.brotons@quinton.es",{"name":27,"role":23,"phone":28,"phoneExt":10,"email":29},"Laboratoires Quinton International, S.L.","+34 965 36 11 01","info@quinton.es",[31,51],{"facility":32,"status":10,"city":33,"state":10,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Clínica Uner","Alicante","03010","Spain","ES",{"type":38,"coordinates":39},"Point",[40,41],-0.48149,38.34517,{"lat":41,"lon":40},[44,48],{"name":45,"role":23,"phone":46,"phoneExt":10,"email":47},"María Jesús Gómez López","+34 965 124 686","info@clinicauner.es",{"name":49,"role":50,"phone":10,"phoneExt":10,"email":10},"Aitor Baño Alcaraz, Physiotherapist and Osteopath","PRINCIPAL_INVESTIGATOR",{"facility":52,"status":10,"city":33,"state":10,"zip":53,"country":35,"countryCode":36,"cosmosGeoPoint":54,"geoPoint":56,"contacts":57},"Nombre de Mujer","03013",{"type":38,"coordinates":55},[40,41],{"lat":41,"lon":40},[58,62],{"name":59,"role":23,"phone":60,"phoneExt":10,"email":61},"África Pol Calderón, Physiotherapy","686 16 48 53","info@nombredemujer.es",{"name":63,"role":50,"phone":10,"phoneExt":10,"email":10},"África Pol Calderón, Physiotherapist",{"type":65,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100612718","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-100612718",false,"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","Nasal Baby","Inclusion Criteria:\n\n* Male and female infants \u002F toddlers aged 3 to 48 months (inclusive) at the time of enrolment.\n* Subjects with flu, cold, allergic rhinitis or rhinosinusitis as reported by their legal guardian(s) and\u002For medical history.\n* Subjects presenting at least moderately bothersome nasal congestion (blocked or stuffy nose) as reported by their legal guardian(s) and\u002For medical history and confirmed by the site investigator through non-diagnostic inspection.\n* Subjects suitable for nasal hygiene treatment with the study device according to its IFU.\n* Subjects with nasal congestion symptoms that began within 48 hours prior to enrolment.\n* Subjects whose legal guardian(s) signed written informed consent on their behalf to participate in the study.\n* Subject whose legal guardian(s) are willing and able to follow the IFU and comply with all study procedures.\n\nExclusion Criteria (if any severe symptoms are seen in the subject, the guardian will be advised to seek medical evaluation by the subject's physician):\n\n* Subjects with known hypersensitivity or intolerance to seawater or any of its natural mineral components (e.g., sodium, chloride, magnesium) as reported by their legal guardian(s) and\u002For medical history.\n* Subjects showing severe symptoms such as persistent fever (\\>38°C), severe cough, ear pain, or respiratory distress, as reported by their legal guardian(s) and\u002For medical history.\n* Subjects whose legal guardian(s) and\u002For medical history report any ongoing medical diagnosis or treatment for acute infection or chronic respiratory disease (e.g., asthma, pneumonia, laryngotracheobronchitis, sinusitis, etc.).\n* Subjects whose legal guardians(s) and\u002For medical history report any type of immunodeficiency.\n* Subjects whose legal guardian(s) and\u002For medical history report a neurological condition that may affect respiratory functioning.\n* Subjects with visible nasal injury, wounds or bleeding, or any condition that may contraindicate the use of the study device according to the device IFU.\n* Subjects who are currently participating or have participated in another clinical investigation within the last 30 days prior to enrolment.\n* Subjects using saline nasal drops or nasal sprays or pumps other than the study product within 12 hours prior to the time of enrolment or during the study.\n* Subjects using the study product within 24 hours prior to the time of enrolment in the study.\n* Subject using antibiotics, antivirals, intranasal medications, decongestants, antihistamines, mucolytics, echinacea, combination cold formulas, supplements containing ≥ 10 mg zinc that could influence symptom scores within 12 hours prior to the time of enrolment or during the study.","ALL","3 Months","48 Months",{"count":77,"type":78},83,"ESTIMATED","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 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.\n\nParticipants will be:\n\n* Evaluated by a healthcare professional for eligibility.\n* Receive treatment with the CE-marked nasal spray according to its Instructions for Use, for up to 14 days.\n* 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.\n\nThis study does not include a comparison group and reflects real-world use of the device in routine pediatric care.",[82,83,84,85,86],"Nasal Congestion","Common Cold","Allergic Rhinitis","Rhinosinusitis","Flu Symptom",[88,89,90,91,92,93,94],"infants","toddlers","Upper Respiratory Tract Infections","Pediatric nasal spray","nasal spray","Seawater isotonic solution","Post-market clinical follow-up (PMCF)","NOT_YET_RECRUITING","2025-11-20",{"date":98,"type":99},"2025-12-02","ACTUAL",{"date":101,"type":78},"2025-12",{"date":103,"type":78},"2026-11",{"name":5,"class":6},2]