[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555407":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":10,"centralContacts":30,"locations":36,"responsibleParty":53,"collaborators":10,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":10,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":10,"maxAge":63,"enrollmentInfo":64,"targetDuration":10,"studyType":67,"phases":10,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Instituto Sistemas Complejos de Ingeniería","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Newborns",null,"Subjects born between April 1st, and September 31st in 2024",[13],"Biological: Nirsevimab",{"label":15,"type":10,"description":16,"interventionNames":17},"Catch-up","Subjects born between October 1st of 2023 and March 31st of 2024",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"High-risk","High-Risk Cohort: Infants born with 29 weeks of gestational age (wga) or less who were born within nine months of the beginning of the RSV season; those born with Bronchopulmonary Dysplasia (BPD), 32 or less wga and\u002For a birth weight less than 1·5 kgs born within one year of the beginning of the RSV season, and newborns 34 or less wga and\u002For weight less than 2·5 kgs born during the RSV season.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"BIOLOGICAL","Nirsevimab","Nirsevimab will be administered in a single dose at birth for newborn cohort and at the beginning of the campaign for the other cohorts under study",[15,19,9],[29],"Beyfortus",[31],{"name":32,"role":33,"phone":34,"phoneExt":10,"email":35},"Leonardo Basso, PhD in Business Administration","CONTACT","56 962295601","l.basso@isci.cl",[37],{"facility":38,"status":39,"city":40,"state":10,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"ISCI","RECRUITING","Santiago","8370398","Chile","CL",{"type":45,"coordinates":46},"Point",[47,48],-70.64827,-33.45694,{"lat":48,"lon":47},[51],{"name":52,"role":33,"phone":34,"phoneExt":10,"email":35},"Leonardo Basso",{"type":54,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100555407","effectiveness-and-impact-of-nirsevimab-in-chile-nirse-cl-100555407",false,"NCT06511687","Effectiveness And Impact Of Nirsevimab In Chile (NIRSE-CL)","Effectiveness And Impact of Nirsevimab In A Nationwide Immunization Program During The 2024 Winter Campaign In Chile (Nirse-CL)","Inclusion Criteria:\n\n* Subjects born between October 1st, 2023, to September 31st, 2024.\n* Subjects born with 29 weeks of gestational age (wga) or less who were born between July 1st, 2023 and October 1st, 2023\n* Subjects born with Bronchopulmonary Dysplasia (BPD), 32 or less wga and\u002For a birth weight less than 1·5 kgs born between April 1st, 2023 and October 1st, 2023.\n\nExclusion Criteria:\n\n* No specific criteria has been reported","ALL","4 Years",{"count":65,"type":66},160000,"ESTIMATED","OBSERVATIONAL","The Nirse-CL study is a collaborative effort between the Ministry of Health of Chile, Instituto Sistemas Complejos de Ingeniería (ISCI), and the Faculty of Medicine of the University of Chile. The primary aim is to determine the effectiveness of the monoclonal antibody nirsevimab in preventing RSV infection in infants based on the integrated analysis of several national databases before, during, and after the implementation of a universal immunization program. The impact of the program on RSV-related health outcomes will also be determined.",[70],"RSV",[70,25],"2024-07-15",{"date":74,"type":75},"2024-07-22","ACTUAL",{"date":77,"type":75},"2024-04-01",{"date":79,"type":66},"2024-10-01",{"name":5,"class":6},1]