Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 7:46 PM
Study NCT ID:
NCT07305350
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-26
First Post:
2025-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EFFICACY OF MELATONIN IN MANAGEMENT OF HYPOXIC ISCHEMIC ENCEPHALOPATHY (HIE) IN NEONATES
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020925', 'term': 'Hypoxia-Ischemia, Brain'}], 'ancestors': [{'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002534', 'term': 'Hypoxia, Brain'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008550', 'term': 'Melatonin'}, {'id': 'D005440', 'term': 'Fluid Therapy'}], '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'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'It is a Randomized control trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-05-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2025-12-12', 'studyFirstSubmitQcDate': '2025-12-12', 'lastUpdatePostDateStruct': {'date': '2025-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neonate survival rate', 'timeFrame': '28 days of life', 'description': 'Role of melatonin will be determined primarily by survival rate in neonates with hypoxic ischemic encephalopathy at 28 days of life.'}], 'secondaryOutcomes': [{'measure': 'Improvement in stage of HIE', 'timeFrame': 'Day 1, 3 and 7 of life', 'description': 'Secondary outcome measures to determine role will be improvement in stage of hypoxic ischemic encephalopathy (based on Thomson score) at day 1, 3 and 7.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypoxic ischemic encephalopathy (HIE)', 'Melatonin', 'Randomized Control Trial'], 'conditions': ['Hypoxic Ischaemic Encephalopathy (HIE)']}, 'referencesModule': {'references': [{'pmid': '34271782', 'type': 'BACKGROUND', 'citation': 'Siddiqui MA, Butt TK. Role of Intravenous Magnesium Sulphate in Term Neonates with Hypoxic Ischemic Encephalopathy (HIE) in a Low-income Country: A Randomised Clinical Trial. J Coll Physicians Surg Pak. 2021 Jul;31(7):817-820. doi: 10.29271/jcpsp.2021.07.817.'}, {'pmid': '34120482', 'type': 'BACKGROUND', 'citation': 'Ran Y, Ye L, Ding Z, Gao F, Yang S, Fang B, Liu Z, Xi J. Melatonin Protects Against Ischemic Brain Injury by Modulating PI3K/AKT Signaling Pathway via Suppression of PTEN Activity. ASN Neuro. 2021 Jan-Dec;13:17590914211022888. doi: 10.1177/17590914211022888.'}, {'pmid': '32156180', 'type': 'BACKGROUND', 'citation': 'Packer CH, Hersh AR, Sargent JA, Caughey AB. Therapeutic hypothermia in severe hypoxic-ischemic encephalopathy: a cost-effectiveness analysis. J Matern Fetal Neonatal Med. 2022 Mar;35(5):890-897. doi: 10.1080/14767058.2020.1733519. Epub 2020 Mar 10.'}, {'pmid': '33155883', 'type': 'BACKGROUND', 'citation': 'Michniewicz B, Al Saad SR, Karbowski LM, Gadzinowski J, Szymankiewicz M, Szpecht D. Organ Complications of Infants with Hypoxic Ischemic Encephalopathy Before Therapeutic Hypothermia. Ther Hypothermia Temp Manag. 2021 Mar;11(1):58-63. doi: 10.1089/ther.2020.0035. Epub 2020 Nov 5.'}, {'pmid': '34513419', 'type': 'BACKGROUND', 'citation': 'Iqbal N, Younus J, Malik M, Fatima B, Imran A, Maqbool S, Irfan Waheed KA, Haque K. The Neuroprotective Efficacy of Postnatal Magnesium Sulfate in Term or Near-Term Infants With Moderate-to-Severe Birth Asphyxia. Cureus. 2021 Aug 2;13(8):e16826. doi: 10.7759/cureus.16826. eCollection 2021 Aug.'}, {'pmid': '33074195', 'type': 'BACKGROUND', 'citation': 'Go H, Saito Y, Maeda H, Maeda R, Yaginuma K, Ogasawara K, Kashiwabara N, Kawasaki Y, Hosoya M. Serum cytokine profiling in neonates with hypoxic ischemic encephalopathy. J Neonatal Perinatal Med. 2021;14(2):177-182. doi: 10.3233/NPM-200431.'}, {'pmid': '36009340', 'type': 'BACKGROUND', 'citation': 'Florido J, Rodriguez-Santana C, Martinez-Ruiz L, Lopez-Rodriguez A, Acuna-Castroviejo D, Rusanova I, Escames G. Understanding the Mechanism of Action of Melatonin, Which Induces ROS Production in Cancer Cells. Antioxidants (Basel). 2022 Aug 20;11(8):1621. doi: 10.3390/antiox11081621.'}, {'pmid': '40350214', 'type': 'BACKGROUND', 'citation': 'Dolan F, Wintermark P. Updates in Treatment of Hypoxic-Ischemic Encephalopathy. Clin Perinatol. 2025 Jun;52(2):321-343. doi: 10.1016/j.clp.2025.02.010. Epub 2025 Mar 21.'}, {'pmid': '37883841', 'type': 'BACKGROUND', 'citation': 'Cornet MC, Kuzniewicz M, Scheffler A, Forquer H, Hamilton E, Newman TB, Wu YW. Perinatal Hypoxic-Ischemic Encephalopathy: Incidence Over Time Within a Modern US Birth Cohort. Pediatr Neurol. 2023 Dec;149:145-150. doi: 10.1016/j.pediatrneurol.2023.08.037. Epub 2023 Aug 31.'}, {'pmid': '40128590', 'type': 'BACKGROUND', 'citation': 'Chakkarapani E, de Vries LS, Ferriero DM, Gunn AJ. Neonatal encephalopathy and hypoxic-ischemic encephalopathy: the state of the art. Pediatr Res. 2025 Dec;98(7):2444-2458. doi: 10.1038/s41390-025-03986-2. Epub 2025 Mar 24.'}, {'pmid': '36164277', 'type': 'BACKGROUND', 'citation': 'Bobba PS, Malhotra A, Sheth KN, Taylor SN, Ment LR, Payabvash S. Brain injury patterns in hypoxic ischemic encephalopathy of term neonates. J Neuroimaging. 2023 Jan;33(1):79-84. doi: 10.1111/jon.13052. Epub 2022 Sep 26.'}, {'pmid': '30108392', 'type': 'BACKGROUND', 'citation': 'Ahmad QM, Chishti AL, Waseem N. Role of melatonin in management of hypoxic ischaemic encephalopathy in newborns: A randomized control trial. J Pak Med Assoc. 2018 Aug;68(8):1233-1237.'}, {'pmid': '33601197', 'type': 'BACKGROUND', 'citation': 'Ahmed J, Pullattayil S AK, Robertson NJ, More K. Melatonin for neuroprotection in neonatal encephalopathy: A systematic review & meta-analysis of clinical trials. Eur J Paediatr Neurol. 2021 Mar;31:38-45. doi: 10.1016/j.ejpn.2021.02.003. Epub 2021 Feb 11.'}]}, 'descriptionModule': {'briefSummary': 'To compare the survival rate and improvement in stage of hypoxic ischemic encephalopathy (HIE) at day 7 of treatment in neonates treated with versus without melatonin in addition to standard supportive therapy.', 'detailedDescription': 'This is a randomized control trial and the purpose of this study is to determine efficacy of melatonin in management of hypoxic ischemic encephalopathy in newborns. Baseline characteristics will be documented after which patients will be divided into two groups by paper lottery method namely group A in which newborns will be given single 10mg dose of melatonin through nasogastric tube in addition to standard supportive therapy and group B in which patients will be given standard supportive therapy only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Hour', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nAll term infants (as per operational definition). Both genders. Presenting with hypoxic ischemic encephalopathy (as per operational definition).\n\nExclusion criteria:\n\nDrug reactions. Newborns at gestational age \\< 36 weeks. Neonates whose mother received general anesthesia. Neonates with congenital malformations. Neonates whose mother received anticonvulsants. Neonates not fulfilling criteria for HIE. Neonatal sepsis, pneumonia or in-born error of metabolism.'}, 'identificationModule': {'nctId': 'NCT07305350', 'briefTitle': 'EFFICACY OF MELATONIN IN MANAGEMENT OF HYPOXIC ISCHEMIC ENCEPHALOPATHY (HIE) IN NEONATES', 'organization': {'class': 'OTHER', 'fullName': "University of Child Health Sciences and Children's Hospital, Lahore"}, 'officialTitle': 'EFFICACY OF MELATONIN IN MANAGEMENT OF HYPOXIC ISCHEMIC ENCEPHALOPATHY (HIE) IN NEONATES', 'orgStudyIdInfo': {'id': 'No/779/CH-UCHS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': '55 neonates will be assigned group A in which newborns will be given single 10mg dose of melatonin through nasogastric tube in addition to standard supportive therapy.', 'interventionNames': ['Drug: Melatonin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': '55 neonates will be assigned group B in which patients will be given standard supportive therapy only. Standard supportive therapy included oxygen therapy, intravenous (IV) fluids, intensive monitoring, broad-spectrum antibiotic cover for possible role of infection', 'interventionNames': ['Combination Product: intravenous (IV) fluids, intensive monitoring, broad-spectrum antibiotic cover']}], 'interventions': [{'name': 'Melatonin', 'type': 'DRUG', 'description': '55 neonates will be assigned group A in which newborns will be given single 10mg dose of melatonin through nasogastric tube in addition to standard supportive therapy.', 'armGroupLabels': ['Group A']}, {'name': 'intravenous (IV) fluids, intensive monitoring, broad-spectrum antibiotic cover', 'type': 'COMBINATION_PRODUCT', 'description': '55 neonates will be assigned group B in which patients will be given standard supportive therapy only.', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05411', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Children Hospital and University of Child Health Sciences, Lahore', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Muhammad Khalid Masood, MBBS, FCPS', 'role': 'STUDY_CHAIR', 'affiliation': 'Children Hospital and University of Child Health Sciences, Lahore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to confidentiality'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "University of Child Health Sciences and Children's Hospital, Lahore", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Amina Cheema', 'investigatorFullName': 'Dr. Amina Cheema', 'investigatorAffiliation': "University of Child Health Sciences and Children's Hospital, Lahore"}}}}