[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594847":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":37,"responsibleParty":67,"collaborators":10,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":10,"maxAge":78,"enrollmentInfo":79,"targetDuration":10,"studyType":82,"phases":10,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":96,"whyStopped":10,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University of Calgary","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HIE infants",null,"Newborns diagnosed with HIE , more than 35 weeks of age, admitted to a neonatal neurocritical care unit in Alberta Children's hospital, undergoing therapeutic hypothermia",[13],"Device: Automated Pupillometer",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Automated Pupillometer","An automated pupillometer will be used to measure pupil size and calculate NPi in newborns with HIE",[9],[21],"Neurological pupil index",[23],{"name":24,"affiliation":25,"role":26},"Khorshid Mohammad, MD, MSc, FRCP, FRCPC","Cummings school of medicine, University of Calgary","PRINCIPAL_INVESTIGATOR",[28,33],{"name":29,"role":30,"phone":31,"phoneExt":10,"email":32},"Khorshid Mohammad, MD, Mac, FRCP, FRCPC","CONTACT","587-893-0700","Khorshid.Mohammad@albertahealthservices.ca",{"name":34,"role":30,"phone":35,"phoneExt":10,"email":36},"Hari Prasath Ramachandran, MD","403-620-0975","hariprasath.ramachandran@albertahealthservices.ca",[38],{"facility":5,"status":10,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Calgary","Alberta","T2N1N4","Canada","CA",{"type":45,"coordinates":46},"Point",[47,48],-114.08529,51.05011,{"lat":48,"lon":47},[51,52,53,55,57,59,61,63,65],{"name":24,"role":30,"phone":31,"phoneExt":10,"email":32},{"name":24,"role":26,"phone":10,"phoneExt":10,"email":10},{"name":34,"role":54,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"name":56,"role":54,"phone":10,"phoneExt":10,"email":10},"Sujith G, MD",{"name":58,"role":54,"phone":10,"phoneExt":10,"email":10},"Juan P Appendino, MD",{"name":60,"role":54,"phone":10,"phoneExt":10,"email":10},"James Scott, MD",{"name":62,"role":54,"phone":10,"phoneExt":10,"email":10},"Taheera Tharani",{"name":64,"role":54,"phone":10,"phoneExt":10,"email":10},"Mandee Chow",{"name":66,"role":54,"phone":10,"phoneExt":10,"email":10},"Parent Sekhon",{"type":68,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100594847","severity-of-hypoxic-ischemic-encephalopathy-and-neurological-pupil-index-in-neonates-100594847",false,"NCT07024771","Severity of Hypoxic Ischemic Encephalopathy and Neurological Pupil Index in Neonates","A Study On Association Between Neurological Pupil Index and Clinical Severity of Hypoxic Ischemic Encephalopathy In Neonates Admitted To Neonatal Neurocritical Care Unit","SHINE","Inclusion Criteria:\n\n* Neonates ≥35 weeks of GA, with Hypoxic ischemic encephalopathy admitted to neonatal neuro-intensive care unit at Alberta children's hospital, Calgary will be included in the study\n\nExclusion Criteria:\n\n* Infants with chromosomal abnormalities\u002F syndromic associations\n* Infants with ocular \u002F orbital injuries or structural anomalies of the eye obscuring the pupillometry measurement\n* Infants with inadequate pupillometry data \u002F EEG data","ALL","6 Hours",{"count":80,"type":81},25,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn if the reactivity of a newborn's eye to light (measured as an index, using a new device -pupillometer) reflect the health of their brain recovering from disruption of blood\u002Foxygen supply during birth (Hypoxic Ischemic Encephalopathy-HIE). The main questions it aims to answer are:\n\n* With a decreasing reactivity index, does the chance of an abnormal electrical function of brain (noted by electroencephalography (EEG)) increase?\n* With a decreasing reactivity index, do the odds of an indicator of severe impact on brain health (abnormal brain imaging, seizures, feeding difficulty) increase? Participants will undergo eye examination using the pupillometer instead of the regular penlight, as part of their routine neurological examination. This will not change the way in which the newborn is being treated and managed medically.",[85],"Hypoxic Ischemic Encephalopathy (HIE)",[21,87,88,89,90,91,92,93,94,95],"Hypoxic ischemic encephalopathy","automated pupillometry","neonatal neurocritical care","severity of HIE","therapeutic hypothermia","cooling therapy","NPi","seizures","EEG","NOT_YET_RECRUITING","2025-06-09",{"date":99,"type":100},"2025-06-17","ACTUAL",{"date":102,"type":81},"2025-08",{"date":104,"type":81},"2026-06",{"name":5,"class":6},1]