Clinical Audit On Management Of Congenital Heart Disease In ACUH

• Conditions: Congenital Heart Disease

• Registration Number: NCT03850223
• Lead Sponsor: Assiut University

Brief Summary

Congenital Heart Disease (CHD) is the most common birth defect in the United States, affecting approximately 0.8% of live births. Improved treatment strategies and interventions have increased survival such that 85% to 90% of affected children are expected to live well into adulthood, thereby causing a demographic shift in which adults now outnumber children with CHD, and more people with complex CHD are living longer.

Detailed Description

CHD may be defined as an anatomic malformation of the heart or great vessels which occurs during intrauterine development, irrespective of the age at presentation. The cause of most congenital heart defects is still unknown. Many cases of congenital heart disease are multifactorial and result from a combination of genetic predisposition and an environmental stimulus. A small percentage of congenital heart lesions are related to known chromosomal abnormalities, in particular, trisomy 21, 13, and 18 and Turner syndrome. Of all cases of congenital heart disease, 2-4% are associated with known environmental or adverse maternal conditions and teratogenic influences, including maternal diabetes mellitus, phenylketonuria, systemic lupus erythematosus or congenital rubella syndrome; and maternal ingestion of drugs (lithium, ethanol, warfarin, antimetabolites, vitamin A derivatives, anticonvulsant agents).

Study Timeline

• Study First Submitted: 2019-02-20
• Study First Submitted QC: 2019-02-20
• Study First Posted: 2019-02-21
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-21
• Last Update Posted: 2020-02-24
• Study Start: 2020-03-01
• Primary Completion: 2021-10-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• children with CHD more than one month

Exclusion Criteria

• children with CHD less than one month

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical audit study to assess management of congenital heart disease in AUCH	One year	To assess how much the adopted protocol of management of congenital heart disease is implemented in Assiut university children hospital