[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mild-hypoxic-ischemic-encephalopathy-of-newborn\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mild-hypoxic-ischemic-encephalopathy-of-newborn":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100410190","cool-prime-comparative-effectiveness-study-for-mild-hie-100410190",false,"NCT04621279","Cool Prime Comparative Effectiveness Study for Mild HIE","COOLPRIME: Comparative Effectiveness for Cooling Prospectively Infants With Mild Encephalopathy","COOLPRIME","Inclusion Criteria:\n\nInfants must meet all 3 inclusion criteria\n\n1. Neonates born at ≥ 36 0\u002F7 weeks\n2. Mild Encephalopathy on neonatal neurologic exam within 6 hours after birth: defined as presence of at least 2 signs of mild, moderate, or severe encephalopathy with no more than 2 signs in the moderate or severe category.\n3. Perinatal Acidosis based on at least one of the following (A or B):\n\n   1. pH ≤ 7.00 in any cord or first infant gas (arterial, venous, or capillary) within ≤ 60 min OR base deficit ≥ 16 in any cord or first infant gas (arterial, venous or capillary) within ≤ 60 min\n   2. If pH is between 7.01 and 7.15, OR base deficit is between 10 and 15.9 mmol\u002Fliter, OR blood gas is not available, an acute perinatal event is an additional criteria required (see below definition)\n\nAn acute perinatal event is defined by at least one of the following:\n\n1. Apgar score at 10 min ≤ 5\n2. Continued need for resuscitation at 10 min (chest compressions, bag mask ventilation, or positive pressure ventilation)\n3. Uterine rupture, placental abruption, cord accident (prolapse, rupture, knot or tight nuchal cord)\n4. maternal trauma, maternal hemorrhage, or cardiorespiratory arrest\n5. fetal exsanguination from either vasa previa or feto-maternal hemorrhage, shoulder dystocia\n6. Any evidence suggestive of acute perinatal event.\n\nInfants are still eligible for enrollment in the COOLPRIME study if the cord or infant's first blood gas (arterial, venous, or capillary) is obtained \\>60 minutes of life.\n\nExclusion Criteria:\n\n1. Gestational age at birth \\\u003C 36 0\u002F7 weeks\n2. Birth weight \\\u003C 1800gm\n3. Head circumference \\\u003C30cm\n4. Congenital or chromosomal anomaly associated with abnormal neurodevelopment or death\n5. Moderate or Severe HIE of 3 or more moderate or severe abnormalities on COOLPRIME Sarnat exam within 6 hours of life\n6. Any seizures within first six hours of life\n7. Redirection of care is being considered","ALL","36 Weeks",{"count":20,"type":21},460,"ESTIMATED","OBSERVATIONAL","To determine effectiveness of therapy to improve neurodevelopmental outcomes in infants with mild HIE. To determine the adverse effects of Therapeutic Hypothermia (TH) in mild HIE on the neonate and his\u002Fher family. Determine heterogeneity of the treatment effect across key subgroups obtained in the first 6 hours after birth prior to the decision to initiate therapy.",[25],"Mild Hypoxic Ischemic Encephalopathy of Newborn",[27,28,29,30],"mild HIE (Hypoxic Ischemic Encephalopathy)","neonatal encephalopathy","brain ischemia","brain hypoxia","RECRUITING","2026-09-21",{"date":34,"type":35},"2026-09-25","ACTUAL",{"date":37,"type":35},"2023-07-19",{"date":39,"type":21},"2029-01-01",{"name":41,"class":42},"University of Texas Southwestern Medical Center","OTHER"]