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

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

Study Overview

• Status: Completed
• Conditions: Infant of Diabetic Mother

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21131
    • Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 1 week (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study was conducted on 50 neonates admitted to the neonatal intensive care unit in Alexandria University Children's Hospital.

This study included two groups:

Group Ι: Include 25 neonates born to diabetic mother Group II: Include 25 neonates born to non-diabetic mothers as a control group (reference group).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Neonates born to diabetic mothers
Neonates born to non-diabetic mothers (control)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of incidence of congenital heart disease in infants of diabetic mothers	This was done using echocardiography: two-dimensional study, color Doppler, pulsed and continuous wave Doppler as well as m-mode study.	First week
Hemodynamic significance of patent ductus arteriosus (PDA)and patent Foramen Ovale (PFO)	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.	First two months of life
Assessment of left ventricular dimensions in infants of diabetic mothers in comparison to healthy controls.	Using M-mode images under guidance of two dimensional echocardiography in parasternal long axis view was done for all participants measuring of the following: Left ventricular end systolic diameter (LVDs).; Left ventricular end diastolic diameter (LVDd).; Inter ventricular septal diameter (IVSd).; Left ventricular posterior wall thickness during diastole (LVPWd).; Left ventricular posterior wall thickness during systole (LVPWs) those measures are compared in infant of diabetic mothers and healthy controls.	First two months of life
Assessment of left ventricular dimensions in infants of diabetic mothers in comparison to healthy controls.	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.	First two months of life

Collaborators and Investigators

• Sponsor: Marwa Mohamed Farag
• Investigators: Principal Investigator: Asmaa MR Emara, MBBCh, Faculty of Medicine, Alexandria University, Egypt; Study Director: Iman M Marzouk, PhD, Faculty of Medicine, Alexandria University, Egypt; Study Director: Aly M Abdel-Mohsen, PhD, Faculty of Medicine, Alexandria University, Egypt

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2020
• Primary Completion (Actual): June 12, 2021
• Study Completion (Actual): June 20, 2021

Study Registration Dates

• First Submitted: September 10, 2021
• First Submitted That Met QC Criteria: September 10, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 25, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Pregnancy in Diabetics; Fetal Diseases
• Other Study ID Numbers: 0106399

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No