[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100208819":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":31,"centralContacts":22,"locations":35,"responsibleParty":233,"collaborators":22,"id":235,"slug":236,"hasResults":237,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":22,"eligibilityCriteria":241,"healthyVolunteers":237,"sex":242,"minAge":22,"maxAge":243,"enrollmentInfo":244,"targetDuration":22,"studyType":247,"phases":248,"briefSummary":250,"conditions":251,"keywords":253,"overallStatus":261,"whyStopped":22,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":270},{"fullName":5,"class":6},"GlaxoSmithKline","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Overall Group","OTHER","Newborn subjects followed up for Lower Respiratory Tract Infections (LRTI) symptoms from birth until they are 2 years of age and for incidence of wheeze and asthma up to 6 years of age.",[13,14,15],"Procedure: Nasal swab sampling","Procedure: Blood sampling","Other: Diary cards",[17,23,27],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"PROCEDURE","Nasal swab sampling","Nasal swab samples will be collected from subjects at each examination visit, if they develop respiratory tract infection symptoms with difficulty in breathing and are called for an examination visit in the study.",[9],null,{"type":18,"name":24,"description":25,"armGroupLabels":26,"otherNames":22},"Blood sampling","A single blood sample will be collected from a sub-cohort consisting of the first 2000 enrolled subjects when they are either 2, 4, 6, 12, 18 or 24 months old.",[9],{"type":10,"name":28,"description":29,"armGroupLabels":30,"otherNames":22},"Diary cards","Diary cards will be provided to parents or LARs of the subjects to record RTI\u002FLRTI, wheeze and asthma symptoms.",[9],[32],{"name":33,"affiliation":5,"role":34},"GSK Clinical Trials","STUDY_DIRECTOR",[36,49,57,62,70,78,87,96,103,112,118,126,136,147,157,165,173,181,191,196,207,217,225],{"facility":37,"status":22,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":22},"GSK Investigational Site","Oakland","California","94611","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-122.2708,37.80437,{"lat":47,"lon":46},{"facility":37,"status":22,"city":50,"state":39,"zip":51,"country":41,"countryCode":42,"cosmosGeoPoint":52,"geoPoint":56,"contacts":22},"Sacramento","95815",{"type":44,"coordinates":53},[54,55],-121.4944,38.58157,{"lat":55,"lon":54},{"facility":37,"status":22,"city":50,"state":39,"zip":58,"country":41,"countryCode":42,"cosmosGeoPoint":59,"geoPoint":61,"contacts":22},"95823",{"type":44,"coordinates":60},[54,55],{"lat":55,"lon":54},{"facility":37,"status":22,"city":63,"state":39,"zip":64,"country":41,"countryCode":42,"cosmosGeoPoint":65,"geoPoint":69,"contacts":22},"Santa Clara","95051",{"type":44,"coordinates":66},[67,68],-121.95524,37.35411,{"lat":68,"lon":67},{"facility":37,"status":22,"city":71,"state":39,"zip":72,"country":41,"countryCode":42,"cosmosGeoPoint":73,"geoPoint":77,"contacts":22},"Walnut 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6R8","Canada","CA",{"type":44,"coordinates":143},[144,145],-63.57688,44.64269,{"lat":145,"lon":144},{"facility":37,"status":22,"city":148,"state":22,"zip":149,"country":150,"countryCode":151,"cosmosGeoPoint":152,"geoPoint":156,"contacts":22},"Kokkola","67100","Finland","FI",{"type":44,"coordinates":153},[154,155],23.13066,63.83847,{"lat":155,"lon":154},{"facility":37,"status":22,"city":158,"state":22,"zip":159,"country":150,"countryCode":151,"cosmosGeoPoint":160,"geoPoint":164,"contacts":22},"Oulu","90220",{"type":44,"coordinates":161},[162,163],25.46816,65.01236,{"lat":163,"lon":162},{"facility":37,"status":22,"city":166,"state":22,"zip":167,"country":150,"countryCode":151,"cosmosGeoPoint":168,"geoPoint":172,"contacts":22},"Pori","28100",{"type":44,"coordinates":169},[170,171],21.78518,61.48072,{"lat":171,"lon":170},{"facility":37,"status":22,"city":174,"state":22,"zip":175,"country":150,"countryCode":151,"cosmosGeoPoint":176,"geoPoint":180,"contacts":22},"Seinäjoki","60100",{"type":44,"coordinates":177},[178,179],22.82822,62.79446,{"lat":179,"lon":178},{"facility":37,"status":22,"city":182,"state":22,"zip":183,"country":184,"countryCode":185,"cosmosGeoPoint":186,"geoPoint":190,"contacts":22},"San Pedro Sula","21101","Honduras","HN",{"type":44,"coordinates":187},[188,189],-88.02588,15.50585,{"lat":189,"lon":188},{"facility":37,"status":22,"city":182,"state":22,"zip":192,"country":184,"countryCode":185,"cosmosGeoPoint":193,"geoPoint":195,"contacts":22},"21102",{"type":44,"coordinates":194},[188,189],{"lat":189,"lon":188},{"facility":37,"status":22,"city":197,"state":198,"zip":199,"country":200,"countryCode":201,"cosmosGeoPoint":202,"geoPoint":206,"contacts":22},"Soweto","Gauteng","2013","South Africa","ZA",{"type":44,"coordinates":203},[204,205],27.85849,-26.26781,{"lat":205,"lon":204},{"facility":37,"status":22,"city":208,"state":22,"zip":209,"country":210,"countryCode":211,"cosmosGeoPoint":212,"geoPoint":216,"contacts":22},"Bangkok","10330","Thailand","TH",{"type":44,"coordinates":213},[214,215],100.50144,13.75398,{"lat":215,"lon":214},{"facility":37,"status":22,"city":218,"state":22,"zip":219,"country":210,"countryCode":211,"cosmosGeoPoint":220,"geoPoint":224,"contacts":22},"Khon Kaen","40002",{"type":44,"coordinates":221},[222,223],102.833,16.44671,{"lat":223,"lon":222},{"facility":37,"status":22,"city":226,"state":22,"zip":227,"country":210,"countryCode":211,"cosmosGeoPoint":228,"geoPoint":232,"contacts":22},"Pathum Thani","12120",{"type":44,"coordinates":229},[230,231],100.53049,14.01346,{"lat":231,"lon":230},{"type":234,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100208819","a-prospective-epidemiological-study-to-assess-the-disease-burden-of-respiratory-syncytial-virus-associated-suspected-lower-respiratory-tract-infections-in-newborns-from-0-to-2-years-of-age-and-risk-of-development-of-wheeze-and-asthma-from-0-to-6-years-of-age-100208819",true,"NCT01995175","A Prospective, Epidemiological Study to Assess the Disease Burden of Respiratory Syncytial Virus Associated, Suspected Lower Respiratory Tract Infections in Newborns, From 0 to 2 Years of Age and Risk of Development of Wheeze and Asthma From 0 to 6 Years of Age","A Prospective, Epidemiological Study to Assess the Disease Burden of RSV Associated, Suspected LRTIs From 0 to 2 Years and Population Attributable Risk Percent of RSV LRTI on the Development of Recurrent Wheeze and Asthma From 0 to 6 Years","Inclusion Criteria:\n\nBefore birth:\n\n* Subject whose parent(s)\u002FLegally Acceptable Representative(s) (LARs), in the opinion of the investigator, can and will comply with the requirements of the protocol.\n* Written informed consent (including consent to obtain a cord blood sample at birth) obtained from the parent(s)\u002FLAR(s) of the subject.\n\nAfter Birth:\n\n* Subject for whom updated and re-signed informed consent and confirmation of eligibility is available not later than 5 working days after birth.\n* Cord blood sample collection of at least 3 mL, at birth.\n\nFor extension period:\n\n* Subject is enrolled at a study site that is participating in the extension period follow-up.\n* Subject whose parent(s)\u002FLAR(s), in the opinion of the investigator, can and will comply with the requirements of the protocol.\n* Written informed consent (or witnessed thumb printed consent in case of an illiterate subject) obtained from the parent(s)\u002FLAR(s) of the subject.\n* Previous participation in the primary study (from birth up to the age of 2 years).\n\nExclusion Criteria:\n\nBefore birth:\n\n* Subject expected to become Child in care\n* Subjects whose parent(s)\u002FLAR(s) are below the age of 18 or the legal consenting age of the respective country if this is higher.\n\nAfter Birth:\n\n* Child in care\n* Newborn with a gestational age of less than 28 weeks.\n* Subjects with any congenital condition that will require an expected postnatal stay in hospital of more than 12 consecutive weeks.\n* Subjects with major congenital defects or serious chronic illness limiting life expectancy to less than 5 years.\n* Subjects with any confirmed or suspected immunosuppressive or immunodeficient condition (including positive infection with human immunodeficiency virus \\[HIV\\]), based on medical history, physical examination or positive test result.\n\nFor extension period:\n\n• Child in care.","ALL","6 Years",{"count":245,"type":246},2409,"ACTUAL","INTERVENTIONAL",[249],"NA","The purpose of this study is to assess the incidence and associated healthcare utilization of RSV-associated, suspected LRTI in a general population of infants from birth up to 2 years of age, and also to assess the accuracy of a newly developed LRTI case definition and severity scale compared to two existing definitions. The study will also assess the population attributable risk percent of RSV LRTI on the development of wheeze and asthma from 0 to 6 years of age.",[252],"Respiratory Syncytial Virus",[254,255,256,257,258,259,260],"Asthma","Respiratory Syncytial virus","Cohort study","Quarterly phone contacts","Wheeze","New born","Lower Respiratory Tract Infection","COMPLETED","2022-11-02",{"date":264,"type":246},"2022-11-29",{"date":266,"type":246},"2013-12-12",{"date":268,"type":246},"2021-11-03",{"name":5,"class":6},23]