[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT02260271":3,"trial-entities:NCT02260271":69,"trial-summary:NCT02260271":73},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":31,"secondary_outcomes":36,"sex":37,"minimum_age":38,"maximum_age":39,"healthy_volunteers":14,"eligibility_criteria":40,"std_ages":51,"locations":53,"central_contacts":62,"overall_officials":63,"references":67,"see_also_links":68},"NCT02260271","IRB201501109","Florida Neonatal Neurologic Network","ENROLLING_BY_INVITATION","2045-12","2026-02","2026-02-11","2011-09-09","University of Florida","OTHER",false,"Create a database with selected medical information on infants born with hypoxic-ischemic encephalopathy (HIE). In addition, the following samples will be collected in a bio-repository for future studies: blood, urine, and buccal samples.","The purpose of this study is to create a detailed medical and sample database of infants born with HIE. Both the medical information and the samples are de-identified. Any future studies performed with the data and samples will receive Institutional Review Board (IRB) approval.",[18],"Hypoxic-Ischemic Encephalopathy",[],"OBSERVATIONAL",null,[],{"count":24,"type":25},1000,"ESTIMATED",[27],{"type":13,"name":28,"description":29,"armGroupLabels":30},"Database Entry\u002FBiospecimen Collection","blood, urine, buccal samples and medical data collected",[28],[32],{"measure":33,"description":34,"timeFrame":35},"Measurement of blood-based biomarkers of neonatal Hypoxic Ischemic Encephalopathy (HIE)","Measure HIE biomarker levels in blood samples obtained in infants born with HIE.","2 years",[],"ALL","1 Day","3 Weeks",{"inclusion":41,"exclusion":46,"raw_text":50},[42,43,44,45],"Gestational Age greater than or equal to 35 weeks gestation","Birth weight greater than or equal to 1.8 kg","Less than or equal to 6 hours since insult occurred","Severe hypoxic-ischemic encepholopathy (HIE)",[47,48,49],"Presence of lethal chromosomal abnormalities","Severe IUGR","Significant intracranial hemorrhage with a large intracranial hemorrhage (Grade III or intraparenchymal echodensity (Grade IV))","Inclusion Criteria:\n\n* Gestational Age greater than or equal to 35 weeks gestation\n* Birth weight greater than or equal to 1.8 kg\n* Less than or equal to 6 hours since insult occurred\n* Severe hypoxic-ischemic encepholopathy (HIE)\n\nExclusion Criteria:\n\n* Presence of lethal chromosomal abnormalities\n* Severe IUGR\n* Significant intracranial hemorrhage with a large intracranial hemorrhage (Grade III or intraparenchymal echodensity (Grade IV))",[52],"CHILD",[54],{"facility":12,"city":55,"state":56,"zip":57,"country":58,"geoPoint":59},"Gainesville","Florida","32610","United States",{"lat":60,"lon":61},29.65163,-82.32483,[],[64],{"name":65,"affiliation":12,"role":66},"Michael D Weiss, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":70,"biomarkers":72},[71],"Hypoxic Ischemic Encephalopathy",[],{"nct_id":4,"found":14,"summary":21,"prompt_version":21}]