[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100432608":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":22,"centralContacts":26,"locations":38,"responsibleParty":54,"collaborators":11,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":11,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":80,"overallStatus":84,"whyStopped":11,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"The Hospital for Sick Children","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Virtual Care","EXPERIMENTAL",null,[13],"Behavioral: Virtual Care",{"label":15,"type":16,"description":11,"interventionNames":11},"Standard of Care","NO_INTERVENTION",[18],{"type":19,"name":9,"description":20,"armGroupLabels":21,"otherNames":11},"BEHAVIORAL","Infants randomized at 4 months of age to the intervention arm will participate in virtual care visits for 16 weeks in addition to standard of care in-hospital visits.",[9],[23],{"name":24,"affiliation":5,"role":25},"Linh Ly, MD","PRINCIPAL_INVESTIGATOR",[27,33],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Sara Santini, BSc","CONTACT","416-813-7654","202827","sara.santini@sickkids.ca",{"name":34,"role":29,"phone":35,"phoneExt":36,"email":37},"Rosanna Yankanah, MSc","416-816-7654","202919","rosanna.yankanah@sickkids.ca",[39],{"facility":5,"status":11,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Toronto","Ontario","M5G 1X8","Canada","CA",{"type":46,"coordinates":47},"Point",[48,49],-79.39864,43.70643,{"lat":49,"lon":48},[52,53],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},{"name":34,"role":29,"phone":30,"phoneExt":36,"email":37},{"type":25,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Linh Ly","Medical Director, NICU and Neonatal Neurodevelopmental Follow-up Clinic","100432608","early-virtual-intervention-for-infants-with-cp-following-hie-diagnosis-100432608",false,"NCT04913324","Early Virtual Intervention for Infants With CP Following HIE Diagnosis","The RECOVER Study - Remote Early Intervention for Cerebral Palsy to Improve Outcomes Using Virtual Care Following pERinatal Asphyxia","RECOVER","Inclusion Criteria:\n\n1. Diagnosis of moderate to severe hypoxic ischemic encephalopathy as defined based on Sarnat criteria 35\n2. Received therapeutic hypothermia\n3. Abnormal brain MRI (deep grey matter, watershed or mixed patterns of injury) in the first seven days of life\n4. Greater than or equal to 34 weeks gestation\n5. Patients are followed by the Neonatal Follow-Up Clinic at SickKids\n6. Abnormal GMA (abnormal or absent fidgety movements) at 12 weeks of age\n\nExclusion Criteria:\n\n1. Known or high suspicion of a genetic syndrome\n2. Residence post-discharge will not be with biological parents\n3. Limited fluency in English\n4. No internet access","ALL","4 Months","5 Months",{"count":69,"type":70},150,"ESTIMATED","INTERVENTIONAL",[73],"NA","This will be a five year study that will be a prospective, randomized, controlled trial (RCT) to assess the effect of a virtual early intervention care delivery model in the provision of therapy to enhance the neurodevelopmental trajectory of infants with brain injury. In addition, the investigators will enhance understanding of the social and parental contributors to outcomes and the early health economic impact of a virtual clinic. The results of this study will help inform the design of a larger, multi-center randomized controlled trial.",[76,77,78,79],"Cerebral Palsy","Hypoxic-Ischemic Encephalopathy","Brain Injuries","Perinatal Hypoxia",[81,76,82,9,77,83,78,79],"HIE","Infant","Follow-Up","NOT_YET_RECRUITING","2021-05-28",{"date":87,"type":88},"2021-06-04","ACTUAL",{"date":90,"type":70},"2021-06-01",{"date":92,"type":70},"2026-12-31",{"name":5,"class":6},1]