[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100497365":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":10,"centralContacts":23,"locations":30,"responsibleParty":59,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":10,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":10,"studyType":79,"phases":10,"briefSummary":80,"conditions":81,"keywords":86,"overallStatus":92,"whyStopped":10,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group",null,"Children aged 9 years old with NE-TH meeting study inclusion criteria.",[13],"Procedure: Therapeutic hypothermia",{"label":15,"type":10,"description":16,"interventionNames":10},"Control group","A comparison group of sex and age matched children with no NE-TH meeting similar study inclusion criteria to intervention group. Specific exclusion criteria for matched control group include a previous history of neurodevelopmental delay or disorder, or a traumatic brain injury, and born at term (gestational age ≥37 weeks), or born without neonatal complication.",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"PROCEDURE","Therapeutic hypothermia","whole-body cooling to an esophageal temperature of 33.5°C initiated within the first 6 hours of life, continued for 72 hours, and then they were slowly rewarmed for moderate or severe NE",[9],[24],{"name":25,"role":26,"phone":27,"phoneExt":28,"email":29},"Marie Brossard-Racine, PhD","CONTACT","(514)934-1934","76295","marie.brossardracine@mcgill.ca",[31,48],{"facility":32,"status":10,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Centre Hospitalier Universitaire Ste-Justine (CHUSJ).","Montreal","Quebec","H3T 1C5","Canada","CA",{"type":39,"coordinates":40},"Point",[41,42],-73.58781,45.50884,{"lat":42,"lon":41},[45,46],{"name":25,"role":26,"phone":27,"phoneExt":28,"email":29},{"name":25,"role":47,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"facility":49,"status":10,"city":33,"state":34,"zip":50,"country":36,"countryCode":37,"cosmosGeoPoint":51,"geoPoint":53,"contacts":54},"the Montreal Children's Hospital (MCH) of the McGill University Health Centre","H4A 3J1",{"type":39,"coordinates":52},[41,42],{"lat":42,"lon":41},[55,56,57],{"name":25,"role":26,"phone":27,"phoneExt":28,"email":29},{"name":25,"role":47,"phone":10,"phoneExt":10,"email":10},{"name":58,"role":47,"phone":10,"phoneExt":10,"email":10},"Pia Wintermark, PhD",{"type":47,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Marie Brossard-Racine","Associate Professor",[63],{"name":64,"class":65},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV","100497365","the-long-term-consequences-of-neonatal-encephalopathy-in-the-hypothermia-era-100497365",false,"NCT05756296","The Long-term Consequences of Neonatal Encephalopathy in the Hypothermia Era","The Long-term Consequences of Neonatal Encephalopathy in the Hypothermia Era: Protocol for a Follow-up Cohort Study at 9 Years of Age","Inclusion Criteria:\n\n* born between 2014 and 2018\n* received whole-body cooling to an esophageal temperature of 33.5°C initiated within the first 6 hours of life, continued for 72 hours, and then they were slowly rewarmed received TH for moderate or severe NE\n\nExclusion Criteria:\n\nParticipants with a history of\n\n* congenital infections\n* genetic or metabolic disorders\n* major brain malformations (e.g., lissencephaly) and\n* any contraindication for MRI (e.g., metal implant, claustrophobia)","ALL","8 Years","11 Years",{"count":77,"type":78},198,"ESTIMATED","OBSERVATIONAL","The goal of this study is to characterize the ability and related brain profiles of children with Neonatal encephalopathy (NE) - Therapeutic hypothermia (TH) at 9 years old. The main questions it aims to answer are:\n\n1. Compare executive function, attention, social cognition, behaviour, anxiety, self-esteem, and peer problems between children with NE-TH and matched peers without NE.\n2. Compare brain volumes, cortical and subcortical morphology, white matter microstructure, and myelination between children with NE-TH and matched peers without NE.\n3. Evaluate the associations of perinatal risk factors and structural brain integrity with neuropsychological deficits to inform about the potential aggravating and protective factors for neuropsychological functioning.\n\nParticipants will complete one study visit to perform standardized evaluations and a brain MRI. Parents of participants will be invited to complete a series of questionnaires during this study visit or at a moment of their choice virtually.",[82,83,84,85],"Neonatal Encephalopathy","Therapeutic Hypothermia","Brain Injuries","Child Development",[87,88,89,90,91,85],"Cerebral Palsy","Brain","Neonate","Developmental Delay","MRI","NOT_YET_RECRUITING","2023-10-19",{"date":95,"type":96},"2023-10-23","ACTUAL",{"date":98,"type":78},"2023-11-01",{"date":100,"type":78},"2028-12-31",{"name":5,"class":6},2]