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

Infant of Diabetic Mother Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05050058
• Other study ID #: 0106399
• Status: Completed
• Start date: March 8, 2020
• Est. completion date: June 20, 2021

Study information

• Verified date: November 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 20, 2021
• Est. primary completion date: June 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 7 Days

Eligibility

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.

Related Conditions & MeSH terms

• Infant of Diabetic Mother
• Pregnancy in Diabetics

Locations

Country	Name	City	State
Egypt	Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Marwa Mohamed Farag

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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