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

NCT05050058 | Completed

• 1 other identifier: 0106399
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this work was to:

1. 1.Evaluate the use of echocardiography in the assessment of hemodynamic stability in newborns.
2. 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

Conditions

Infant of Diabetic Mother

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Neonates born to diabetic mothers

Neonates born to non-diabetic mothers (control)

Eligibility Criteria

• Age: 0 Days - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Marwa Mohamed Farag: lead

Study Sites (1)

Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.

Alexandria, 21131, Egypt

Location

Related Publications (1)

• 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.

  PMID: 20451803 BACKGROUND

Study Officials

• Asmaa MR Emara, MBBCh

  Faculty of Medicine, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

• Iman M Marzouk, PhD

  Faculty of Medicine, Alexandria University, Egypt

  STUDY DIRECTOR

• Aly M Abdel-Mohsen, PhD

  Faculty of Medicine, Alexandria University, Egypt

  STUDY DIRECTOR

• Marwa M Farag, PhD

  Faculty of Medicine, Alexandria University, Egypt

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer in Pediatrics, Faculty of Medicine

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 20, 2021
• Study Start: March 8, 2020
• Primary Completion: June 12, 2021
• Study Completion: June 20, 2021
• Last Updated: November 30, 2022

Record last verified: 2022-11

Locations

EG (1)