Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-04-15 @ 6:12 AM
Study NCT ID:
NCT02071160
Status:
COMPLETED
Last Update Posted:
2014-02-25
First Post:
2014-02-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Melatonin for Neuroprotection Following Perinatal Asphyxia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007035', 'term': 'Hypothermia'}, {'id': 'D001927', 'term': 'Brain Diseases'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008550', 'term': 'Melatonin'}], 'ancestors': [{'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-23', 'studyFirstSubmitDate': '2014-02-23', 'studyFirstSubmitQcDate': '2014-02-23', 'lastUpdatePostDateStruct': {'date': '2014-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum melatonin concentration (pg/ ml)', 'timeFrame': '5 days'}, {'measure': 'Plasma superoxide dismutase (SOD) activity (U/ml)', 'timeFrame': '5 days'}, {'measure': 'Serum nitric oxide (NO) concentrations (µmol/L)', 'timeFrame': '5 days'}], 'secondaryOutcomes': [{'measure': 'Incidence of EEG abnormalities', 'timeFrame': '2 weeks'}, {'measure': 'Incidence of MRI abnormalities', 'timeFrame': '2 weeks'}, {'measure': 'Incidence of abnormal neurological examination', 'timeFrame': '6 months'}, {'measure': 'Incidence of abnormal Denver Developmental Screening Test II', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIE', 'hypothermia', 'encephalopathy', 'anti oxidants', 'MRI'], 'conditions': ['Perinatal Asphyxia']}, 'referencesModule': {'references': [{'pmid': '15168319', 'type': 'BACKGROUND', 'citation': 'Gitto E, Reiter RJ, Cordaro SP, La Rosa M, Chiurazzi P, Trimarchi G, Gitto P, Calabro MP, Barberi I. Oxidative and inflammatory parameters in respiratory distress syndrome of preterm newborns: beneficial effects of melatonin. Am J Perinatol. 2004 May;21(4):209-16. doi: 10.1055/s-2004-828610.'}, {'pmid': '14966737', 'type': 'BACKGROUND', 'citation': 'Gitto E, Romeo C, Reiter RJ, Impellizzeri P, Pesce S, Basile M, Antonuccio P, Trimarchi G, Gentile C, Barberi I, Zuccarello B. Melatonin reduces oxidative stress in surgical neonates. J Pediatr Surg. 2004 Feb;39(2):184-9; discussion 184-9. doi: 10.1016/j.jpedsurg.2003.10.003.'}, {'pmid': '22370283', 'type': 'BACKGROUND', 'citation': 'Chen YC, Tain YL, Sheen JM, Huang LT. Melatonin utility in neonates and children. J Formos Med Assoc. 2012 Feb;111(2):57-66. doi: 10.1016/j.jfma.2011.11.024. Epub 2012 Feb 15.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to examine the effect of combining melatonin to whole body cooling on the brain injury and outcome of neonates following perinatal asphyxia.', 'detailedDescription': 'This is a prospective study on 30 neonates with moderate to moderately to severe hypoxic ischemic encephalopathy (HIE) . HIE infants are randomized into two groups: Whole body cooling group (N = 15; receive 72 hours of whole body hypothermia) and melatonin/ hypothermia group (N = 15; receive hypothermia and 5 daily enteral doses of melatonin 10 mg/kg). Serum melatonin, plasma superoxide dismutase (SOD),and serum nitric oxide (NO) are measured at enrollment and after 2 weeks for the two HIE groups. The HIE groups underwent electroencephalography at enrollment and at 2 to 3 weeks. Brain MRI was performed after 2 weeks of life. Neurologic evaluations and Denver Developmental Screening Test II assessments were performed at 6 months. A group of healthy newborns will be used as a control for baseline labs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Hours', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inborn infants at term gestation (38-42 weeks)\n* Apgar scores ≤ 3 at 5 minutes and/or delayed first breath (\\>5 minutes after birth)\n* Profound metabolic or mixed acidosis with serum bicarbonate levels of \\<12 mmol/L in initial blood gas analyses\n* Evidence of moderate or moderate to severe encephalopathy, such as lethargy, seizures, abnormal reflexes, or hypotonia, in the immediate neonatal period\n\nExclusion Criteria:\n\n* Twin gestation\n* Maternal neuro-endocrinal disturbances including diabetes mellitus\n* Chorioamnionitis or congenital infections\n* Low birth weight less than 2.5 kg\n* Congenital malformations of the central nervous system or gastrointestinal anomalies\n* Chromosomal abnormalities\n* After 6 hours of birth.\n* Patients in extremis such as: (1) hypoxemia requiring supplemental oxygen 100% FiO2, (2) life threatening coagulopathy, or (3) deep coma.'}, 'identificationModule': {'nctId': 'NCT02071160', 'briefTitle': 'Melatonin for Neuroprotection Following Perinatal Asphyxia', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Melatonin for Neuroprotection Following Perinatal Asphyxia', 'orgStudyIdInfo': {'id': '01012012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Healthy Control', 'description': 'A group of healthy control without any history suggestive of perinatal asphyxia or other diseases, are enrolled to compare different laboratory measurements'}, {'type': 'NO_INTERVENTION', 'label': 'Hypothermia Group', 'description': 'HIE infants who will not receive melatonin and only receive routine cooling protocol.'}, {'type': 'EXPERIMENTAL', 'label': 'Melatonin/ hypothermia group', 'description': 'HIE infants who will receive melatonin in addition to the routine cooling protocol', 'interventionNames': ['Drug: Melatonin']}], 'interventions': [{'name': 'Melatonin', 'type': 'DRUG', 'description': "Melatonin is administered to the melatonin/hypothermia group (n=15) in a dose of 10 mg/kg daily for a total of 5 doses starting immediately at enrollment. Melatonin tablets (1 or 3 mg/tablet) (Puritan's Pride,Oakdale, NY, USA) are crushed, then dissolved in 5-10 ml of distilled water , then administered via an orogastric tube.", 'armGroupLabels': ['Melatonin/ hypothermia group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'state': 'Gharbia Governorate', 'country': 'Egypt', 'facility': "Tanta University Children's Hospital", 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'Heba Mahdy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tanta University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics', 'investigatorFullName': 'Heba Mahdy', 'investigatorAffiliation': 'Tanta University'}}}}