Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-02-25 @ 11:02 PM
Study NCT ID:
NCT03630367
Status:
WITHDRAWN
Last Update Posted:
2021-04-23
First Post:
2018-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of L-Carnitine Supplementation on Respiratory Distress Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002331', 'term': 'Carnitine'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Unavailability of the medication', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-22', 'studyFirstSubmitDate': '2018-08-04', 'studyFirstSubmitQcDate': '2018-08-10', 'lastUpdatePostDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the mean difference in the Apgar score after birth', 'timeFrame': '1 minute', 'description': 'Assessment of fetal general condition'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Premature Birth']}, 'descriptionModule': {'briefSummary': 'The aim of the present study was to investigate the efficacy of L-carnitine therapy on the occurrence and prognosis of respiratory distress syndrome'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women between 30-37 weeks\n* singleton pregnancy\n\nExclusion Criteria:\n\n* congenital malformed fetus\n* Extreme premature'}, 'identificationModule': {'nctId': 'NCT03630367', 'briefTitle': 'Effects of L-Carnitine Supplementation on Respiratory Distress Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effects of Adding L-Carnitine With Dexamethasone on Respiratory Distress Syndrome Development in Preterm Infants', 'orgStudyIdInfo': {'id': 'LCPET'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study group', 'description': 'women will receive dexamethasone 8 mg intramuscular every 8 hours plus single injection of L-carnitine 1 gm slow intravenous', 'interventionNames': ['Drug: Dexamethasone', 'Drug: L-Carnitine 1G/5mL Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'women will receive dexamethasone 8 mg intramuscular every 8 hours plus single injection of saline 1 gm slow intravenous', 'interventionNames': ['Drug: Dexamethasone']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Intramuscular injection 8 mg', 'armGroupLabels': ['control group', 'study group']}, {'name': 'L-Carnitine 1G/5mL Injection', 'type': 'DRUG', 'description': 'slow intravenous injection', 'armGroupLabels': ['study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '002', 'city': 'Assiut', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Ahmed Abbas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ahmed Mohamed Abbas', 'investigatorAffiliation': 'Assiut University'}}}}