[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100256803":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":47,"centralContacts":51,"locations":61,"responsibleParty":112,"collaborators":114,"id":117,"slug":118,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":121,"acronym":31,"eligibilityCriteria":122,"healthyVolunteers":119,"sex":123,"minAge":31,"maxAge":124,"enrollmentInfo":125,"targetDuration":31,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":31,"overallStatus":63,"whyStopped":31,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"University of Florida","OTHER",[8,17,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants 1-10","EXPERIMENTAL","This group will receive a 0.5 mg\u002Fkg enteral dose of Melatonin. The first dose will be administered via enteral route within 12 hours of life with a target of 6 hours of life.\n\nThe melatonin will be administered as a single dose for the first 5 participants in allowing the investigators to determine if the dosing frequency has the potential to decrease in the elimination with hypothermia. The next 5 subjects who will receive multiple doses if there are not any safety concerns.\n\nAdditionally, the participants will have the following test performed: Magnetic Resonance Imaging (MRI), Neurological Outcome Assessment, Pharmacokinetics, and safety monitoring.",[13,14,15,16],"Drug: Melatonin","Other: Magnetic Resonance Imaging","Other: Pharmacokinetics","Behavioral: Neurological Outcome Assessment",{"label":18,"type":10,"description":19,"interventionNames":20},"Participants 11-20","This group will the Melatonin dose of 3 mg\u002Fkg enteral, only if the group Participants 1-10 has meet the safety goals. The first dose will be administered via enteral route within 12 hours of life with a target of 6 hours of life.\n\nThe melatonin will be administered as a single dose for the first 5 participants in allowing the investigators to determine if the dosing frequency has the potential to decrease in the elimination with hypothermia. The next 5 subjects who will receive multiple doses if there are not any safety concerns.\n\nAdditionally, the participants will have the following test performed: Magnetic Resonance Imaging (MRI), Neurological Outcome Assessment, Pharmacokinetics, and safety monitoring.",[13,14,15,16],{"label":22,"type":10,"description":23,"interventionNames":24},"Participants 21-30","This group will receive Melatonin dose of 5 mg\u002Fkg enterally, only if the group Participants 11-20 has meet the safety goals. The first dose will be administered via enteral route within 12 hours of life with a target of 6 hours of life.\n\nThe melatonin will be administered as a single dose for the first 5 participants in allowing the investigators to determine if the dosing frequency has the potential to decrease in the elimination with hypothermia. The next 5 subjects who will receive multiple doses if there are not any safety concerns.\n\nAdditionally, the participants will have the following test performed: Magnetic Resonance Imaging (MRI), Neurological Outcome Assessment, Pharmacokinetics, and safety monitoring.",[13,14,15,16],[26,32,38,42],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Melatonin","Participants 1-10 will receive a 0.5 mg\u002Fkg enteral dose of Melatonin. Participants 11-20 will receive Melatonin dose of 3 mg\u002Fkg enteral. Participants 21-30 will receive Melatonin dose of 5 mg\u002Fkg enterally.",[9,18,22],null,{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Magnetic Resonance Imaging","All participants will receive an MRI between 7-12 days of age.",[9,18,22],[37],"MRI",{"type":6,"name":39,"description":40,"armGroupLabels":41,"otherNames":31},"Pharmacokinetics","All participants will receive pharmacokinetics to test the amount of melatonin in the blood.",[9,18,22],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":31},"BEHAVIORAL","Neurological Outcome Assessment","All participants will receive the Bayley-III Scores and Subsets for neurological outcome assessments.",[9,18,22],[48],{"name":49,"affiliation":5,"role":50},"Michael D Weiss, MD","PRINCIPAL_INVESTIGATOR",[52,57],{"name":53,"role":54,"phone":55,"phoneExt":31,"email":56},"Alison A McMurray, M.A.M.C.","CONTACT","3526275016","amcmurra@ufl.edu",{"name":58,"role":54,"phone":59,"phoneExt":31,"email":60},"Kristine Boykin, BSN","3522738706","kristineboykin@ufl.edu",[62,97],{"facility":5,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"RECRUITING","Gainesville","Florida","32610","United States","US",{"type":70,"coordinates":71},"Point",[72,73],-82.32483,29.65163,{"lat":73,"lon":72},[76,78,82,83,85,88,90,91,93,95],{"name":53,"role":54,"phone":77,"phoneExt":31,"email":56},"352-627-5016",{"name":79,"role":54,"phone":80,"phoneExt":31,"email":81},"Michael Weiss, MD","3522738985","weissmd@peds.ufl.edu",{"name":49,"role":50,"phone":31,"phoneExt":31,"email":31},{"name":84,"role":50,"phone":31,"phoneExt":31,"email":31},"Giuseppe Buonocore, MD",{"name":86,"role":87,"phone":31,"phoneExt":31,"email":31},"Candace Rossignol, Sr. Lab Tech","SUB_INVESTIGATOR",{"name":89,"role":87,"phone":31,"phoneExt":31,"email":31},"Ronald Hayes, MD",{"name":58,"role":87,"phone":31,"phoneExt":31,"email":31},{"name":92,"role":50,"phone":31,"phoneExt":31,"email":31},"Rajan Wadhawan, MD",{"name":94,"role":87,"phone":31,"phoneExt":31,"email":31},"Nicole Copenhaver, BA, ASN",{"name":96,"role":87,"phone":31,"phoneExt":31,"email":31},"Ganna Zalevska, BS, RRT",{"facility":98,"status":63,"city":99,"state":65,"zip":100,"country":67,"countryCode":68,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Florida Hospital for Children","Orlando","32803",{"type":70,"coordinates":102},[103,104],-81.37924,28.53834,{"lat":104,"lon":103},[107,111],{"name":108,"role":54,"phone":109,"phoneExt":31,"email":110},"Rajan Wadhawan, M.D.","407-303-2528","Rajan.Wadhawan.MD@flhosp.org",{"name":92,"role":50,"phone":31,"phoneExt":31,"email":31},{"type":113,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[115],{"name":116,"class":6},"Thrasher Research Fund","100256803","early-phase-1-melatonin-as-a-neuroprotective-therapy-in-neonates-with-hie-undergoing-hypothermia-100256803",false,"NCT02621944","Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia","Inclusion Criteria:\n\n* Eligible infants are \\>36 0\u002F7th weeks gestation,\n* pH (cord or neonatal) \\\u003C7.0,\n* base deficit \\>16 mEq\u002FL,\n* no available blood gas,\n* a cord blood\u002Ffirst hour of life blood gas with pH \\> 7.0 and \\\u003C 7.15,\n* base deficit between 10 and 15.9 mEq\u002FL,\n* infants must have a history of an acute perinatal event,\n* either a 10-minute Apgar \\\u003C 5 or a continued need for ventilation,\n* All infants must have signs of encephalopathy within 6 hours of age using the modified Sarnat scoring system,\n* neonates cooled within 6 hours of birth will be included in the study.\n\nExclusion Criteria:\n\n* suspected inborn errors of metabolism (elevated ammonia) and hypoglycemia,\n* clinical signs and symptoms consistent with meningitis detected upon sepsis evaluation,\n* a diagnosis of congenital abdominal surgical problems along with multiple congenital anomalies and\u002For chromosomal abnormalities.","ALL","6 Hours",{"count":126,"type":127},70,"ESTIMATED","INTERVENTIONAL",[130],"EARLY_PHASE1","Hypoxic-Ischemic Encephalopathy (HIE) occurs in 20 per 1000 births. Only 47% of neonates treated with the state of the art therapy (induced systemic hypothermia) have normal outcomes. Therefore, other promising therapies that potentially work in synergy with hypothermia to improve neurologic outcomes need to be tested. One potential agent is melatonin. Melatonin is a naturally occurring substance produced mainly from the pineal gland. Melatonin is widely known for its role in regulating the circadian rhythm, but it has many other effects that may benefit infants with HI injury. Melatonin serves as a free radical scavenger, decreases inflammatory cytokines, and stimulates anti-oxidant enzymes. Therefore, melatonin may interrupt several key components in the pathophysiology of HIE, in turn minimizing cell death and improving outcomes. The research study will evaluate the neuroprotective properties and appropriate dose of Melatonin to give to infants undergoing therapeutic hypothermia for hypoxic ischemic encephalopathy.",[133],"Hypoxic Ischemic Encephalopathy","2026-06-25",{"date":136,"type":137},"2026-06-29","ACTUAL",{"date":139,"type":137},"2016-11-09",{"date":141,"type":127},"2027-03",{"name":5,"class":6},2]