Congenital Heart Defects

NCT06124443 | Not Yet Recruiting

• 1 other identifier: Congenital heart defects
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Describe the relationship between maternal diabetes and congenital heart defects in infants born to diabetic mothers referred to NICU unit \& Outpatient clinics of Assiut University Childeren's hospital.We will compare between 2 groups. Cases will represent infants of diabetic mothers \& Conteols will represent infants of non-diabetic mothers.

Conditions

Congenital Heart Defects

Outcome Measures

Primary Outcomes (1)

• Assesment of prevalence of congenital heart defects among infants of diabetic mother compared to that in infants of non-diabetic mothers.

  Assesment of prevalence of congenital heart defects among infants of diabetic mother compared to that in infants of non-diabetic mothers.

  Baseline

Study Arms (2)

Cases

Infants \& children of diabetic mothers

Controls

Infants \& children of non-diabetic mothers

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Neonates and children of diabetic and non-diabetic mothers

You may qualify if:

• The study will include infants of diabetic mothers and infants of non-diabetic mothers not previously screened for congenital heart defects.

You may not qualify if:

• Other risk factors for congenital heart defects including congenital infections like TORCH infection, teratogenic drugs ( lithium or isotretinoin), , alcohol, or smoking.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• Al-Biltagi M, Tolba OA, Rowisha MA, Mahfouz Ael-S, Elewa MA. Speckle tracking and myocardial tissue imaging in infant of diabetic mother with gestational and pregestational diabetes. Pediatr Cardiol. 2015 Feb;36(2):445-53. doi: 10.1007/s00246-014-1033-0. Epub 2014 Oct 7.

  PMID: 25287219 BACKGROUND

• Classification and diagnosis of diabetes mellitus and other categories of glucose intolerance. National Diabetes Data Group. Diabetes. 1979 Dec;28(12):1039-57. doi: 10.2337/diab.28.12.1039. No abstract available.

  PMID: 510803 BACKGROUND

• Aburawi EH. The burden of congenital heart disease in libya. Libyan J Med. 2006 Sep 8;1(2):120-2. doi: 10.4176/060902. No abstract available.

  PMID: 21526009 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Moustafa Adel Mohamed Ahmed

CONTACT

+201123248863; dr.mostafaaboelsoud2020@gmail.com

Mohamed Gamil Mohamed Aboelela, Dr

CONTACT

+201024741834; mohamedgamilmohamed@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 71515,Assiut

Study Record Dates

• First Submitted: November 5, 2023
• First Posted: November 9, 2023
• Study Start: December 1, 2024
• Primary Completion: February 28, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: November 9, 2023

Record last verified: 2023-11