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OpenTrials
Completed

NCT Number: NCT05050058

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

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Key information

Conditions

Infant of Diabetic Mother

Age range

0 day–7 day

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Alexandria, 21131, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Detection of incidence of congenital heart disease in infants of diabetic mothers

    Time frame: First week

    This was done using echocardiography: two-dimensional study, color Doppler, pulsed and continuous wave Doppler as well as m-mode study.

  2. Hemodynamic significance of patent ductus arteriosus (PDA)and patent Foramen Ovale (PFO)

    Time frame: 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.

  3. Assessment of left ventricular dimensions in infants of diabetic mothers in comparison to healthy controls.

    Time frame: 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:

    • 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.

  4. Assessment of left ventricular dimensions in infants of diabetic mothers in comparison to healthy controls.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Marwa Mohamed Farag

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 20, 2021
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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