[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100269979":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":12,"centralContacts":16,"locations":25,"responsibleParty":63,"collaborators":66,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":7,"eligibilityCriteria":77,"healthyVolunteers":74,"sex":78,"minAge":7,"maxAge":79,"enrollmentInfo":80,"targetDuration":7,"studyType":83,"phases":7,"briefSummary":84,"conditions":85,"keywords":7,"overallStatus":27,"whyStopped":7,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Boston Children's Hospital","OTHER",null,[9],{"type":10,"name":11,"description":7,"armGroupLabels":7,"otherNames":7},"DEVICE","Near-Infrared Spectroscopy (NIRS)",[13],{"name":14,"affiliation":5,"role":15},"Patricia Ellen Grant, MD","PRINCIPAL_INVESTIGATOR",[17,22],{"name":18,"role":19,"phone":20,"phoneExt":7,"email":21},"Rutvi Vyas, MS","CONTACT","857-218-5445","rutvi.vyas@childrens.harvard.edu",{"name":23,"role":19,"phone":20,"phoneExt":7,"email":24},"Sarah Blackwell","sarah.blackwell@childrens.harvard.edu",[26,39,52],{"facility":5,"status":27,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":7},"RECRUITING","Boston","Massachusetts","02115","United States","US",{"type":34,"coordinates":35},"Point",[36,37],-71.05977,42.35843,{"lat":37,"lon":36},{"facility":40,"status":41,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":42,"geoPoint":44,"contacts":45},"Brigham and Women's Hospital","NOT_YET_RECRUITING",{"type":34,"coordinates":43},[36,37],{"lat":37,"lon":36},[46,47,50],{"name":18,"role":19,"phone":20,"phoneExt":7,"email":21},{"name":48,"role":19,"phone":20,"phoneExt":7,"email":49},"Francesca Yi","francesca.yi@childrens.harvard.edu",{"name":51,"role":15,"phone":7,"phoneExt":7,"email":7},"Terrie Inder, MD",{"facility":53,"status":41,"city":28,"state":29,"zip":54,"country":31,"countryCode":32,"cosmosGeoPoint":55,"geoPoint":57,"contacts":58},"Beth Israel Deaconess Medical Center","02215",{"type":34,"coordinates":56},[36,37],{"lat":37,"lon":36},[59,60,61],{"name":18,"role":19,"phone":20,"phoneExt":7,"email":21},{"name":48,"role":19,"phone":20,"phoneExt":7,"email":49},{"name":62,"role":15,"phone":7,"phoneExt":7,"email":7},"Jonathan Litt, MD",{"type":15,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"Ellen Grant","Professor of Radiology",[67,68,69],{"name":40,"class":6},{"name":53,"class":6},{"name":70,"class":71},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100269979","perinatal-brain-injury-potential-of-innovative-nirs-to-optimize-hypothermia-100269979",false,"NCT02793999","Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia","Inclusion criteria:\n\nNeonates must be \\> 33 weeks gestational age (GA) and meet inclusion criteria for one of the two groups:\n\n1. Therapeutic Hypothermia (TH) Group:\n\n   1. Undergo TH as part of their clinical management\n   2. Parents consent to multiple measures in the first week of life.\n2. No Therapeutic Hypothermia (no-TH) Group:\n\n   1. Signs will be defined broadly as any one of the following which can be considered evidence of NE caused by HIE or other etiologies: i) Seizures alone or ii) any of the following: abnormal consciousness, difficulty maintaining respiration, difficulty feeding (presumed central origin), abnormal tone or reflexes.\n   2. Parents consent to multiple measures in the first week of life.\n\nExclusion criteria:\n\nExclusion criteria includes neonates born at GA ≤ 33 weeks or \\\u003C 2.0 kg, with implanted devices or other devices that preclude the use of MRI will be excluded from the follow up MRI session.","ALL","2 Years",{"count":81,"type":82},125,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to improve the ability of the investigators to monitor brain health in newborn babies at risk of brain injuries. The researchers will be using an investigational system of devices to non-invasively (that, is, without penetrating the skin), measure the amount of oxygen going to and being used by the brain. They will be taking some bedside research measurements during the babies' stay at the hospital. With these measurements, the intention is to study the role of oxygen in brain injury and test the efficacy of the research device and its potential as a permanent bedside diagnostic device.",[86,87],"Hypoxic Ischemic Brain Injury","Neonatal Encephalopathy","2025-12-09",{"date":90,"type":91},"2025-12-10","ACTUAL",{"date":93,"type":7},"2015-05",{"date":95,"type":82},"2028-05",{"name":5,"class":6},3]