[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529993":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":10,"centralContacts":10,"locations":30,"responsibleParty":51,"collaborators":10,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":10,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":10,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Hospital Clinico Universitario de Santiago","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"At birth cohort",null,"Subjects born from September 25, 2023 to March 31 in each of the 3 RSV seasons under study 2023\u002F2024, 2024\u002F2025, 2025\u002F2026",[13],"Biological: Nirsevimab",{"label":15,"type":10,"description":16,"interventionNames":17},"Risk Cohort","Subjects with risk factors born between 1 October 2021 and 31 March 2023",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Catch-up cohort","Subjects born between 1 April and 24 September 2023",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"BIOLOGICAL","Nirsevimab","Nirsevimab will be administered administered in a single dose at birth for birth cohort and at the beginning of the campaign for the other cohorts under study",[9,19,15],[29],"Beyfortus",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Hospital Clínico Universitario de Santiago de Compostela","RECRUITING","Santiago de Compostela","A Coruña","15707","Spain","ES",{"type":40,"coordinates":41},"Point",[42,43],-8.54569,42.88052,{"lat":43,"lon":42},[46],{"name":47,"role":48,"phone":49,"phoneExt":10,"email":50},"Federico Martinón Torres, PhD, MD","CONTACT","+34981955373","federico.martinon.torres@sergas.es",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Federico Martinón Torres","Principal investigator","100529993","evaluation-of-the-effectiveness-and-impact-of-nirsevimab-administered-as-routine-immunization-100529993",false,"NCT06180993","Evaluation of the Effectiveness and Impact of Nirsevimab Administered as Routine Immunization","NIRSE-GAL","Inclusion Criteria:\n\n* Subjects born in Galicia from April 1st, 2023 and March 1st, 2026\n\nExclusion Criteria:\n\n* No specific criteria has been reported","ALL","1 Day","24 Months",{"count":66,"type":67},42000,"ESTIMATED","OBSERVATIONAL","A longitudinal observational study based on routinely collected data on hospital and health care use for RSV infections will be undertaken. The Galician public health registries will be used for data collection including baseline information and follow-up data. Historical data will be retrieved for comparison purposes. The study aims to observe and analyze data from all the eligible children in Galicia for nirsevimab treatment. The number of eligible children is expected to be approximately 14,000 per each RSV season.",[71],"RSV Infection","2023-12-21",{"date":74,"type":75},"2023-12-26","ACTUAL",{"date":77,"type":75},"2023-09-25",{"date":79,"type":67},"2026-10-31",{"name":53,"class":6},1]