- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03850223
Clinical Audit On Management Of Congenital Heart Disease In ACUH
February 21, 2020 updated by: Fadwa Magdy Mohamed Abdou, Assiut University
Clinical Audit On Management Of Congenital Heart Disease In Assiut Children University Hospital
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.
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mostafa Shafeek Khalaf, Professor
- Phone Number: +201112110096
- Email: mostafa.tawfeek1@med.au.edu.eg
Study Contact Backup
- Name: Khaled Abdelaziz Sanusy, Assistant Professor
- Phone Number: +201003068421
- Email: khalids@aun.edu.eg
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Children with congenital heart disease more than one month and less than 18 years
Description
Inclusion Criteria:
- children with CHD more than one month
Exclusion Criteria:
- children with CHD less than one month
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical audit study to assess management of congenital heart disease in AUCH
Time Frame: One year
|
To assess how much the adopted protocol of management of congenital heart disease is implemented in Assiut university children hospital
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 1, 2020
Primary Completion (Anticipated)
October 1, 2021
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
February 20, 2019
First Submitted That Met QC Criteria
February 20, 2019
First Posted (Actual)
February 21, 2019
Study Record Updates
Last Update Posted (Actual)
February 24, 2020
Last Update Submitted That Met QC Criteria
February 21, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOCHD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Congenital Heart Disease
-
University of UlsterBelfast Health and Social Care TrustCompletedCongenital Heart Disease | Congenital Heart Defect | Adult Congenital Heart DiseaseUnited Kingdom
-
Vanderbilt University Medical CenterEnrolling by invitationCongenital Heart Disease | Congenital Heart Defect | Congenital Heart MalformationsUnited States
-
Children's Hospital Medical Center, CincinnatiNational Heart, Lung, and Blood Institute (NHLBI)CompletedHeart Disease CongenitalUnited States
-
Assistance Publique Hopitaux De MarseilleRecruitingComplex Congenital Heart DiseaseFrance
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI); Boston Children's HospitalEnrolling by invitation
-
Universitas Sumatera UtaraIndonesia UniversityCompletedCyanotic Congenital Heart DiseaseIndonesia
-
Paul FinnCompletedPediatric Congenital Heart DiseaseUnited States
-
The Hospital for Sick ChildrenTerminatedCongenital Heart Disease (CHD)
-
The Hospital for Sick ChildrenCompletedCongenital Heart Disease (CHD)Canada
-
YHAlattarNot yet recruitingCritical Congenital Heart Disease