Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT07090720
Status:
COMPLETED
Last Update Posted:
2025-07-29
First Post:
2025-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Melatonin Effects on the Left Ventricular Function in Neonates With Persistent Pulmonary Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2025-07-21', 'studyFirstSubmitQcDate': '2025-07-21', 'lastUpdatePostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left ventricle global longitudinal strain', 'timeFrame': 'Immediately after medication (Up to 1 hour)', 'description': 'Left ventricle global longitudinal strain (LV-GLS) was recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Melatonin', 'Left Ventricular Function', 'Neonates', 'Persistent Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate the effect of melatonin on the left ventricular function in neonates with persistent pulmonary hypertension', 'detailedDescription': "Persistent pulmonary hypertension of the newborn (PPHN) is a potentially deadly disorder in which the circulation of the fetus is unable to adjust to the extrauterine environment. Persistently high pulmonary pressures may cause right-to-left shunting, hypoxia, and right ventricular failure.\n\nMelatonin, a neurohormone produced by the pineal gland, offers an exceptional defense against reactive oxygen species (ROS). Infants are unable to synthesize melatonin during their first few weeks of life, which may exacerbate oxidative stress in hypoxic conditions. Additionally, Melatonin's antioxidative capabilities have been shown in neonatal pulmonary and respiratory disorders."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '36 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Neonates of ≥ 36 weeks of gestational age.\n* Both sexes.\n* Admitted with persistent pulmonary hypertension.\n\nExclusion Criteria:\n\n* Preterm infants \\< 36 weeks of gestation.\n* Infants with congenital heart diseases.\n* Infants with dysrhythmia.\n* Chromosomal abnormalities.\n* Severe pathological jaundice.\n* Metabolic or endocrinal disorders.\n* Major congenital malformations.'}, 'identificationModule': {'nctId': 'NCT07090720', 'briefTitle': 'Melatonin Effects on the Left Ventricular Function in Neonates With Persistent Pulmonary Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Melatonin Effects on the Left Ventricular Function in Neonates With Persistent Pulmonary Hypertension', 'orgStudyIdInfo': {'id': '36173//12/22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I', 'description': 'Neonates were given Melatonin.', 'interventionNames': ['Drug: Melatonin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group II', 'description': 'Neonates received placebo.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Melatonin', 'type': 'DRUG', 'description': 'Neonates were given Melatonin.', 'armGroupLabels': ['Group I']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Neonates received placebo.', 'armGroupLabels': ['Group II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'country': 'Egypt', 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Pediatrics, Faculty of Medicine, Tanta University, Tanta, Egypt.', 'investigatorFullName': 'Asmaa Mahmoud Abdel Hamid Elmesiry', 'investigatorAffiliation': 'Tanta University'}}}}