Echocardiographic Findings in Infants of Diabetic Mothers and Its Relation to Maternal Glycemic Control

Completed

• Conditions: Infant of Diabetic Mother

• Registration Number: NCT05050058
• Lead Sponsor: Marwa Mohamed Farag

Brief Summary

The aim of this work was to:

1. Evaluate the use of echocardiography in the assessment of hemodynamic stability in newborns.

2. 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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-08
• Primary Completion: 2021-06-12
• Study Completion: 2021-06-20
• Study First Submitted: 2021-09-10
• Study First Submitted QC: 2021-09-10
• Study First Posted: 2021-09-20
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-25
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Infant of diabetic mother (IDM) (pregestational and gestational diabetes) born in Alexandria University Children 's Hospital (AUCH) whatever their weight or their gestational age

Exclusion Criteria

• Neonates aged more 7 days.
• Patient born outside the tertiary center of Alexandria University Children 's Hospital.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of left ventricular dimensions in infants of diabetic mothers in comparison to healthy controls.	First two months of life	Using M-mode images under guidance of two dimensional echocardiography in parasternal long axis view was done for all participants measuring of the following: * Ejection fraction (EF) .; * Fractional shortening (FS). those measures are compared in infant of diabetic mothers and healthy controls.
Detection of incidence of congenital heart disease in infants of diabetic mothers	First week	This was done using echocardiography: two-dimensional study, color Doppler, pulsed and continuous wave Doppler as well as m-mode study.
Hemodynamic significance of patent ductus arteriosus (PDA)and patent Foramen Ovale (PFO)	First two months of life	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.

Trial Locations

Locations (1)

Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.; 🇪🇬 Alexandria, Egypt