Clinical trial NCT05050058: Echocardiographic Findings in Infants of Diabetic Mothers and Its Relation to Maternal Glycemic Control
Official title: Echocardiographic Findings in Infants of Diabetic Mothers and Its Relation to Maternal Glycemic Control
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant of Diabetic Mother
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-09-20
Enrollment: 50
Sex: ALL
Minimum age (years): 0
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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


Eligibility criteria: 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.

Primary outcomes:
measure: Detection of incidence of congenital heart disease in infants of diabetic mothers
timeFrame: First week
measure: Hemodynamic significance of patent ductus arteriosus (PDA)and patent Foramen Ovale (PFO)
timeFrame: First two months of life
measure: Assessment of left ventricular dimensions in infants of diabetic mothers in comparison to healthy controls.
timeFrame: First two months of life
measure: Assessment of left ventricular dimensions in infants of diabetic mothers in comparison to healthy controls.
timeFrame: First two months of life
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.
Study officials:
affiliation: Faculty of Medicine, Alexandria University, Egypt
name: Asmaa MR Emara, MBBCh
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine, Alexandria University, Egypt
name: Iman M Marzouk, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Alexandria University, Egypt
name: Aly M Abdel-Mohsen, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Alexandria University, Egypt
name: Marwa M Farag, PhD
role: STUDY_CHAIR
References:
citation: 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.