Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2026-02-25 @ 8:17 PM
Study NCT ID:
NCT03767361
Status:
COMPLETED
Last Update Posted:
2020-09-02
First Post:
2017-08-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study the Effect of Blood Transfusion on Oxidant-antioxidant Status in Term and Near-term Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065227', 'term': 'Transfusion Reaction'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-31', 'studyFirstSubmitDate': '2017-08-07', 'studyFirstSubmitQcDate': '2018-12-05', 'lastUpdatePostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'malondialdehyde', 'timeFrame': '2-3 hours posttransfusion', 'description': 'MDA'}, {'measure': 'total antioxidant capacity', 'timeFrame': '2-3 hours posttransfusion', 'description': 'TAC'}, {'measure': 'serum Copper', 'timeFrame': '2-3 hours posttransfusion', 'description': 's.Cu'}, {'measure': 'serum Zinc', 'timeFrame': '2-3 hours posttransfusion', 'description': 's.Zn'}, {'measure': 'serum magnesium', 'timeFrame': '2-3 hours posttransfusion', 'description': 's.Mg'}, {'measure': 'serum iron', 'timeFrame': '2-3 hours posttransfusion', 'description': 's.Fe'}, {'measure': 'serum Calcium', 'timeFrame': '2-3 hours posttransfusion', 'description': 's.Ca'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Blood Transfusion Complication', 'Oxidative Stress']}, 'descriptionModule': {'briefSummary': 'Primary aim is to evaluate the effect of blood transfusion on oxidant-antioxidant status in premature neonates. Secondary aim is to assess the effect of the age of transfused red blood cells on the biological markers of oxidative stress.', 'detailedDescription': 'Oxidant-antioxidant status will be assessed by measuring total antioxidant capacity (TAC) and malondialdehyde (MDA), as well as antioxidant minerals, in 65 term and near-term neonates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '37 Weeks', 'minimumAge': '35 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Premature neonates ≤36 weeks in need for blood transfusion.\n\nExclusion Criteria:\n\n* Critically ill neonates.(perinatal asphaxia,on high setting mechanical ventilation,different types of shock eg ;septic shock and major congenital anomalies)\n* Extremely low birth weight neonates(\\<1000gm birth weight )\n* Recipient of blood transfusion before enrollment in the study.\n* Neonates planned for exchange transfusion .'}, 'identificationModule': {'nctId': 'NCT03767361', 'briefTitle': 'Study the Effect of Blood Transfusion on Oxidant-antioxidant Status in Term and Near-term Neonates', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Study the Effect of Blood Transfusion on Oxidant-antioxidant Status in Term and Near-term Neonates', 'orgStudyIdInfo': {'id': 'MS2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fresh PRBCs', 'description': 'Neonates will receive fresh packed red blood cells transfusion within 7 days of donation', 'interventionNames': ['Biological: packed red blood cells transfusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Old PRBCs', 'description': 'Neonates will receive fresh packed red blood cells transfusion older than 7 days yet within the standard range accepted universally will be transfused to this group.', 'interventionNames': ['Biological: packed red blood cells transfusion']}], 'interventions': [{'name': 'packed red blood cells transfusion', 'type': 'BIOLOGICAL', 'description': 'packed red blood cells transfusion', 'armGroupLabels': ['Fresh PRBCs', 'Old PRBCs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11381', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Rania Farrash', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Rania A. El-Farrash, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rania Ali El-Farrash', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Rania Ali El-Farrash', 'investigatorAffiliation': 'Ain Shams University'}}}}