Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-31 @ 4:13 PM
Study NCT ID:
NCT05050058
Status:
COMPLETED
Last Update Posted:
2022-11-30
First Post:
2021-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Echocardiographic Findings in Infants of Diabetic Mothers and Its Relation to Maternal Glycemic Control
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': '2020-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-25', 'studyFirstSubmitDate': '2021-09-10', 'studyFirstSubmitQcDate': '2021-09-10', 'lastUpdatePostDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of incidence of congenital heart disease in infants of diabetic mothers', 'timeFrame': 'First week', 'description': 'This was done using echocardiography: two-dimensional study, color Doppler, pulsed and continuous wave Doppler as well as m-mode study.'}, {'measure': 'Hemodynamic significance of patent ductus arteriosus (PDA)and patent Foramen Ovale (PFO)', 'timeFrame': 'First two months of life', 'description': 'This was done using echocardiography: two-dimensional study, color Doppler, pulsed and continuous wave Doppler as well as m-mode study for assessments of PDA and PFO in infants of diabetic mothers in comparison with healthy controls.'}, {'measure': 'Assessment of left ventricular dimensions in infants of diabetic mothers in comparison to healthy controls.', 'timeFrame': 'First two months of life', 'description': 'Using M-mode images under guidance of two dimensional echocardiography in parasternal long axis view was done for all participants measuring of the following:\n\n* Left ventricular end systolic diameter (LVDs).\n* Left ventricular end diastolic diameter (LVDd).\n* Inter ventricular septal diameter (IVSd).\n* Left ventricular posterior wall thickness during diastole (LVPWd).\n* Left ventricular posterior wall thickness during systole (LVPWs) those measures are compared in infant of diabetic mothers and healthy controls.'}, {'measure': 'Assessment of left ventricular dimensions in infants of diabetic mothers in comparison to healthy controls.', 'timeFrame': 'First two months of life', 'description': 'Using M-mode images under guidance of two dimensional echocardiography in parasternal long axis view was done for all participants measuring of the following:\n\n* Ejection fraction (EF) .\n* Fractional shortening (FS). those measures are compared in infant of diabetic mothers and healthy controls.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infant of Diabetic Mother']}, 'referencesModule': {'references': [{'pmid': '20451803', 'type': 'BACKGROUND', 'citation': 'Lopez L, Colan SD, Frommelt PC, Ensing GJ, Kendall K, Younoszai AK, Lai WW, Geva T. Recommendations for quantification methods during the performance of a pediatric echocardiogram: a report from the Pediatric Measurements Writing Group of the American Society of Echocardiography Pediatric and Congenital Heart Disease Council. J Am Soc Echocardiogr. 2010 May;23(5):465-95; quiz 576-7. doi: 10.1016/j.echo.2010.03.019. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this work was to:\n\n1. Evaluate the use of echocardiography in the assessment of hemodynamic stability in newborns.\n2. Determine the prevalence of congenital heart diseases or any cardiac abnormalities in infants born to diabetic mother in relation to the glycemic control of their mothers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Days', 'minimumAge': '0 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The study was conducted on 50 neonates admitted to the neonatal intensive care unit in Alexandria University Children's Hospital.\n\nThis study included two groups:\n\nGroup Ι: Include 25 neonates born to diabetic mother Group II: Include 25 neonates born to non-diabetic mothers as a control group (reference group).", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Infant of diabetic mother (IDM) (pregestational and gestational diabetes) born in Alexandria University Children 's Hospital (AUCH) whatever their weight or their gestational age\n\nExclusion Criteria:\n\n* Neonates aged more 7 days.\n* Patient born outside the tertiary center of Alexandria University Children 's Hospital."}, 'identificationModule': {'nctId': 'NCT05050058', 'briefTitle': 'Echocardiographic Findings in Infants of Diabetic Mothers and Its Relation to Maternal Glycemic Control', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Echocardiographic Findings in Infants of Diabetic Mothers and Its Relation to Maternal Glycemic Control', 'orgStudyIdInfo': {'id': '0106399'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Neonates born to diabetic mothers'}, {'label': 'Neonates born to non-diabetic mothers (control)'}]}, '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': 'Asmaa MR Emara, MBBCh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine, Alexandria University, Egypt'}, {'name': 'Iman M Marzouk, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Medicine, Alexandria University, Egypt'}, {'name': 'Aly M Abdel-Mohsen, 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'}}}}