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NCT03850223 Clinical Trial

Clinical Audit On Management Of Congenital Heart Disease In ACUH

Congenital Heart Disease Clinical Trial

Official title:
Clinical Audit On Management Of Congenital Heart Disease In Assiut Children University Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03850223
Other study ID # MOCHD
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date December 1, 2021

Study information
Verified date February 2020
Source Assiut University
Contact Mostafa Shafeek Khalaf, Professor
Phone +201112110096
Email mostafa.tawfeek1@med.au.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date December 1, 2021
Est. primary completion date October 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Month to 18 Years
Eligibility Inclusion Criteria:

- children with CHD more than one month

Exclusion Criteria:

- children with CHD less than one month

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical audit study to assess management of congenital heart disease in AUCH To assess how much the adopted protocol of management of congenital heart disease is implemented in Assiut university children hospital One year
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