Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2025-12-31 @ 2:01 AM
Study NCT ID:
NCT05050032
Status:
COMPLETED
Last Update Posted:
2022-06-15
First Post:
2021-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between Superior Vena Cava Flow and Intraventricular Hemorrhage in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-13', 'studyFirstSubmitDate': '2021-09-10', 'studyFirstSubmitQcDate': '2021-09-10', 'lastUpdatePostDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Superior vena cava (SVC) flow', 'timeFrame': 'Day 1', 'description': 'This was measured using echocardiography. SVC diameter will be visualized from a high parasternal long axis view. The maximum and minimum internal diameters will be then measured off-line from a frozen two-dimensional image showing the vessel walls at the point where SVC starts to open up into the right atrium. Mean of the maximum and minimum diameter used for the flow calculation.\n\n* SVC flow velocity will be visualized from a low subcostal view and the pulsed Doppler recording will be made at the junction of the SVC and the right atrium. Velocity time integral (VTI) will be calculated from the Doppler velocity tracings and averaged over 5 consecutive cardiac cycles.\n* SVC flow will be calculated using the method described by Kluckow and Evans:\n\nSVC flow (ml/kg/min) = {VTI (cm/beat) × 3.14 × (mean SVC diameter2/4) × heart rate (beat/min) }/body weight in kg'}, {'measure': 'Intraventricular hemorrhage (IVH) assessment', 'timeFrame': 'Day 1', 'description': 'Cranial ultrasound will be performed after the echocardiography:\n\n* Machine: model GE Vivid iq premium.\n* Probe: GE 8C-RS probe with a frequency range of 3.5 - 10 MHz.\n* Cranial ultrasound will be done and any IVH will be noted and classified according to Papile grading:\n\nGrade I: Hemorrhage limited to germinal matrix Grade II: Blood noted within the ventricular system but not distending it Grade III: Blood in the ventricles with distension of the ventricles Grade IV: Intraventricular hemorrhage with parenchymal extension'}, {'measure': 'Intraventricular hemorrhage (IVH) assessment', 'timeFrame': 'Day 3', 'description': 'Cranial ultrasound will be performed after the echocardiography:\n\n* Machine: model GE Vivid iq premium.\n* Probe: GE 8C-RS probe with a frequency range of 3.5 - 10 MHz.\n* IVH will be noted and classified according to Papile grading:\n\nGrade I: Hemorrhage limited to germinal matrix Grade II: Blood noted within the ventricular system but not distending it Grade III: Blood in the ventricles with distension of the ventricles Grade IV: Intraventricular hemorrhage with parenchymal extension'}, {'measure': 'Intraventricular hemorrhage (IVH) assessment', 'timeFrame': 'Day 7', 'description': 'Cranial ultrasound will be performed after the echocardiography:\n\n* Machine: model GE Vivid iq premium.\n* Probe: GE 8C-RS probe with a frequency range of 3.5 - 10 MHz.\n* Cranial ultrasound will be done and any IVH will be noted and classified according to Papile grading:\n\nGrade I: Hemorrhage limited to germinal matrix Grade II: Blood noted within the ventricular system but not distending it Grade III: Blood in the ventricles with distension of the ventricles Grade IV: Intraventricular hemorrhage with parenchymal extension'}, {'measure': 'Anterior cerebral artery (ACA) flow velocity assessment', 'timeFrame': 'Day 1', 'description': 'Transcranial Doppler (TCD) ultrasonography was used to assess the anterior cerebral artery flow velocity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False}, 'conditionsModule': {'conditions': ['Preterm Intraventricular Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '10794783', 'type': 'BACKGROUND', 'citation': 'Kluckow M, Evans N. Superior vena cava flow in newborn infants: a novel marker of systemic blood flow. Arch Dis Child Fetal Neonatal Ed. 2000 May;82(3):F182-7. doi: 10.1136/fn.82.3.f182.'}, {'pmid': '305471', 'type': 'BACKGROUND', 'citation': 'Papile LA, Burstein J, Burstein R, Koffler H. Incidence and evolution of subependymal and intraventricular hemorrhage: a study of infants with birth weights less than 1,500 gm. J Pediatr. 1978 Apr;92(4):529-34. doi: 10.1016/s0022-3476(78)80282-0.'}, {'pmid': '36171508', 'type': 'DERIVED', 'citation': 'Farag MM, Gouda MH, Almohsen AMA, Khalifa MA. Intraventricular hemorrhage prediction in premature neonates in the era of hemodynamics monitoring: a prospective cohort study. Eur J Pediatr. 2022 Dec;181(12):4067-4077. doi: 10.1007/s00431-022-04630-5. Epub 2022 Sep 28.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study was to evaluate the relationship between superior vena cava (SVC) flow measurements within the first 24 hours of life and development of intraventricular hemorrhage in preterm born infants.', 'detailedDescription': 'A prospective, observational cohort study was carried out on newborns that fulfill the eligibility criteria and delivered at the Alexandria University Maternity Hospital (AUMH).\n\nThe Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital with total admissions of approximately 2100 newborn per year of which approximately more than 50% are admitted due to prematurity and its complications.\n\nThe study was carried out in 3 phases:\n\n1. First phase: Enrollment and selection phase.\n2. Second phase: Monitoring and Evaluation phase.\n3. Third phase: Statistical analysis of the data'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Day', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Newborns with very low birth weight (≤1500 g) or ≤ 32 weeks gestation who were admitted to neonatal intensive care unit in the first day of life where evaluation of the relationship between superior vena cava (SVC) flow measurements within the first 24 hours of life and development of intraventricular hemorrhage were assessed.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newborns with very low birth weight (≤1500 g) or ≤ 32 weeks gestation who were admitted to neonatal intensive care unit in the first day of life.\n\nExclusion Criteria:\n\n* Newborns (more than 32 weeks of gestation\n* Newborns with birth weight more than 1500 g.\n* Newborns with congenital heart diseases excluding (patent ductus arteriosus and patent foramen ovale)\n* Newborns with major congenital malformations.\n* Newborns with birth trauma especially basal skull/temporal bone fractures that require hospitalization'}, 'identificationModule': {'nctId': 'NCT05050032', 'briefTitle': 'The Relationship Between Superior Vena Cava Flow and Intraventricular Hemorrhage in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Study to Assess the Relationship Between Superior Vena Cava Flow and Intraventricular Hemorrhage in Preterm Infants', 'orgStudyIdInfo': {'id': '0106381'}}, 'contactsLocationsModule': {'locations': [{'zip': '21131', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Mohamed AM Khalifa, MBBCh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine, Alexandria University, Egypt'}, {'name': 'Mohamed H Gouda, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Medicine, Alexandria University, Egypt'}, {'name': 'Ali M Abd Almohsen, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Medicine, Alexandria University, Egypt'}, {'name': 'Marwa M Farag, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Medicine, Alexandria University, Egypt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marwa Mohamed Farag', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Lecturer in Pediatrics, Faculty of Medicine', 'investigatorFullName': 'Marwa Mohamed Farag', 'investigatorAffiliation': 'Alexandria University'}}}}