[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533495":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":21,"locations":30,"responsibleParty":49,"collaborators":52,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":70,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Stony Brook University","OTHER",[8,12,15,18],{"label":9,"type":10,"description":11,"interventionNames":10},"Category 1: Confirmed cCMV infection identified by NYS newborn screen",null,"Infants who have both a positive cCMV NYS newborn screen AND are positive for cCMV on confirmatory testing",{"label":13,"type":10,"description":14,"interventionNames":10},"Category 2: Confirmed cCMV infection NOT identified by NYS newborn screen","Infants who have both a NEGATIVE cCMV NYS newborn screen AND are found to have cCMV on confirmatory testing",{"label":16,"type":10,"description":17,"interventionNames":10},"Category 3: False-positive cCMV NYS newborn screen","Infants who have both a positive cCMV NYS newborn screen AND are NEGATIVE for cCMV on confirmatory testing",{"label":19,"type":10,"description":20,"interventionNames":10},"Category 4: Premature infants with confirmed CMV infection on late positive NBS","Infants who are: (a) born prior to 37 weeks gestation AND (b) cCMV positive on any NYS newborn screen collected prior to 44 weeks gestational age AND (c) Have a positive cCMV confirmatory test obtained within 14 days of a positive NYS newborn screen",[22,27],{"name":23,"role":24,"phone":25,"phoneExt":10,"email":26},"Andrew Handel, MD","CONTACT","631-444-7692","Andrew.handel@stonybrookmedicine.edu",{"name":28,"role":24,"phone":25,"phoneExt":10,"email":29},"Sharon Nachman, MD","sharon.nachman@stonybrookmedicine.edu",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Stony Brook Children's Hospital","RECRUITING","Stony Brook","New York","11794","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-73.14094,40.92565,{"lat":43,"lon":42},[46,47],{"name":23,"role":24,"phone":25,"phoneExt":10,"email":26},{"name":23,"role":48,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"type":48,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Andrew S Handel","Physician",[53],{"name":54,"class":55},"Frontier Science & Technology Research Foundation, Inc.","INDUSTRY","100533495","long-term-outcomes-of-children-with-congenital-cmv-in-new-york-state-100533495",false,"NCT06226558","Long-Term Outcomes of Children With Congenital CMV in New York State","Prospective Observational Study of Asymptomatic cCMV Transmission to Infants for Virological Evaluation in New York State","PROACTIVE NYS","Inclusion Criteria:\n\n* Neonates born in New York State during cCMV NBS Pilot Program (September 27, 2023 - October 1, 2024)\n* cCMV evaluation provided by a designated NYS cCMV clinical referral site\n* Family willing and able to complete all study procedures\n* Study participants meet criteria for one of the following four categories:\n* 1\\. Category 1 (Confirmed cCMV identified by NBS Program): cCMV NYS newborn screen positive AND cCMV confirmatory test positive\n* 2\\. Category 2 (Confirmed cCMV not identified by NBS Program): cCMV NYS newborn screen negative AND cCMV confirmatory test positive\n* 3\\. Category 3 (False-positive cCMV screen): cCMV NYS newborn screen positive AND negative cCMV confirmatory test\n* 4\\. Category 4 (Premature infants with confirmed CMV infection on late positive NBS): Infant born prior to 37 weeks gestation AND cCMV positive on any NYS newborn screen collected prior to 44 weeks gestational age AND Positive cCMV confirmatory test obtained within 14 days of a positive NBS\n\nExclusion Criteria:\n\n* Neonate whose parents refuse participation in the long-term follow-up study","ALL","0 Days","1 Year",{"count":68,"type":69},1000,"ESTIMATED","2 Years","OBSERVATIONAL","PROACTIVE NYS is a long-term follow-up study of all infants who test positive for congenital Cytomegalovirus infection (CMV) throughout New York State on the Newborn Screen. By following all infants who screen positive, we will learn important information about the range of symptoms caused by congenital CMV, from those babies with more severe findings to those with no symptoms.\n\nIn particular, our study will provide new information about many facets of congenital CMV, including:\n\n* Developmental, hearing, neurologic, and vision outcomes\n* The spectrum and timing of symptoms\n* The impact congenital CMV has on the baby and its family\n* How many babies are infected with congenital CMV in New York State How antiviral medications and other interventions impact outcomes of children with congenital CMV\n\nThroughout the duration of the study, children will undergo routine developmental and hearing assessments, which will assist with early diagnosis of any infection complications.\n\nAny child found to have a neurodevelopmental, hearing, or vision abnormality will be referred for appropriate evaluation and treatment.\n\nFamilies will also be asked to complete periodic surveys about their experience with congenital CMV, both as a medical diagnosis and as it affects their day-to-day activities.",[74,75],"Congenital CMV Infection","Sensorineural Hearing Loss",[77,78,79,80,81],"Congenital CMV","cCMV","Congenital infection","Sensorineural hearing loss","SNHL","2025-05-12",{"date":84,"type":85},"2025-05-13","ACTUAL",{"date":87,"type":85},"2024-02-01",{"date":89,"type":69},"2026-10-01",{"name":5,"class":6},1]