Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-28 @ 5:17 PM
Study NCT ID:
NCT05367466
Status:
COMPLETED
Last Update Posted:
2022-05-10
First Post:
2022-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Factors of Neonatal Thrombosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-05', 'studyFirstSubmitDate': '2022-05-05', 'studyFirstSubmitQcDate': '2022-05-05', 'lastUpdatePostDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thrombosis in the neonatal period is multifactorial', 'timeFrame': 'January 2022'}, {'measure': 'Hereditary thrombophilia factors also should be thought', 'timeFrame': 'January 2022'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['newborn, hereditary risk factors'], 'conditions': ['Thrombosis']}, 'referencesModule': {'references': [{'pmid': '36859514', 'type': 'DERIVED', 'citation': 'Guzoglu N, Albayrak M, Aliefendioglu D. Evaluation of Patients with Neonatal Thrombosis. Indian J Pediatr. 2023 Jun;90(6):615-617. doi: 10.1007/s12098-023-04497-w. Epub 2023 Mar 2.'}]}, 'descriptionModule': {'briefSummary': 'The incidence of symptomatic thrombosis is between 2.4 and 6.8 per 1000 neonatal intensive care unit admission while it is 5.1 per 100 000 live births. Compared to adults, the anticoagulant and fibrinolytic system of newborns is significantly different.\n\nIn this study, the aim is to evaluate infants with neonatal thrombosis in our unit to characterize acquired and genetic risk factors, the laboratory work-up parameters and the diagnosis approach.', 'detailedDescription': "All newborn patients diagnosed with neonatal thrombosis in our NICU between 2014 and 2019; were included in the study.\n\nPatients' data: maternal and neonatal characteristics, consanguinity, need for resuscitation, Apgar scores, diagnoses, need for mechanical ventilation, sepsis, catheter placement, treatment regimens and hospital outcomes; Laboratory findings: CBC; D-dimer levels and the performed genetic test Thrombosis diagnosis was confirmed by imaging techniques such as ultrasonography (USG), echocardiography, and magnetic resonance imaging (MRI).\n\nThe genotypes: Factor V (Leiden) G1691A, prothrombin G20210A, MTHFRC677T, MTHFRA1298C, PAI-SERPINE1, Factor XIII V34L mutations"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All newborns in NICU during 5 year period', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All newborn accepted at NICU\n\nExclusion Criteria:\n\n* No'}, 'identificationModule': {'nctId': 'NCT05367466', 'briefTitle': 'Risk Factors of Neonatal Thrombosis', 'organization': {'class': 'OTHER', 'fullName': 'Kırıkkale University'}, 'officialTitle': 'Evaluation of Acquired and Hereditary Risk Factors of Neonatal Thrombosis: Single-centre Experience', 'orgStudyIdInfo': {'id': '2022.03.38'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Newborn with thrombossis', 'description': 'All admitted newborns in NICU during the study period'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kırıkkale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof', 'investigatorFullName': 'Nilufer Guzoglu', 'investigatorAffiliation': 'Kırıkkale University'}}}}