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

NCT ID: NCT05050058

Last Updated: 2022-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-08

Study Completion Date

2021-06-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infant of Diabetic Mother

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Neonates born to diabetic mothers

No interventions assigned to this group

Neonates born to non-diabetic mothers (control)

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

0 Days

Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Marwa Mohamed Farag

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Marwa Mohamed Farag

Lecturer in Pediatrics, Faculty of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Asmaa MR Emara, MBBCh

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Alexandria University, Egypt

Iman M Marzouk, PhD

Role: STUDY_DIRECTOR

Faculty of Medicine, Alexandria University, Egypt

Aly M Abdel-Mohsen, PhD

Role: STUDY_DIRECTOR

Faculty of Medicine, Alexandria University, Egypt

Marwa M Farag, PhD

Role: STUDY_CHAIR

Faculty of Medicine, Alexandria University, Egypt

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Alexandria, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 20451803 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0106399

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.