- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06492473
Clinical Evaluation Of Ventricular Septal Defect (VSD) In Children at Sohag Univesity Hospital
July 8, 2024 updated by: Amany Sabry Thabet, Sohag University
Clinical Evaluation Of Ventricular Septal Defect (VSD) in Children at Sohag University Hospital
ventricular septal defect(VSD) are one of the most common significant CHD and account for up to 40% of all cardiac abnormalities.VSD is commonly isolated defect as well as intrinsic component of several complex cardiac malformations including tetrology of fallot ,double- outlet right ventricle(RV),transposition of great vessles,aortic coartication or interruption ,and truncus arteriosus
Study Overview
Study Type
Observational
Enrollment (Estimated)
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: mohamed A mohamed, Professor
Study Contact Backup
- Name: amany S Thabit, Resident
- Phone Number: 01200074781
- Email: amany.saber@med.sohag.edu.eg
Study Locations
-
-
-
Sohag, Egypt
- Recruiting
- Sohag University Hospitals
-
Contact:
- Magdy M Amin, professor
-
-
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
- Child
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
all children from date of birth to age of 16 years old including both genders diagnosed to have isolated VSD or apart from another cardiac anomalies
Description
Inclusion Criteria:
- all children from date of birth to age of 16 years old including both genders diagnosed to have isolated VSD or apart from another cardiac anomalies
Exclusion Criteria:
-
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 |
|---|---|---|
|
size of VSD
Time Frame: 12 months
|
size of VSD in mm according echocardiology
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Saxena A, Mehta A, Sharma M, Salhan S, Kalaivani M, Ramakrishnan S, Juneja R. Birth prevalence of congenital heart disease: A cross-sectional observational study from North India. Ann Pediatr Cardiol. 2016 Sep-Dec;9(3):205-9. doi: 10.4103/0974-2069.189122.
- Soto B, Becker AE, Moulaert AJ, Lie JT, Anderson RH. Classification of ventricular septal defects. Br Heart J. 1980 Mar;43(3):332-43. doi: 10.1136/hrt.43.3.332.
- Soto B, Ceballos R, Kirklin JW. Ventricular septal defects: a surgical viewpoint. J Am Coll Cardiol. 1989 Nov 1;14(5):1291-7. doi: 10.1016/0735-1097(89)90430-0.
- Kirklin JK, Castaneda AR, Keane JF, Fellows KE, Norwood WI. Surgical management of multiple ventricular septal defects. J Thorac Cardiovasc Surg. 1980 Oct;80(4):485-93.
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 (Actual)
June 24, 2024
Primary Completion (Estimated)
June 24, 2025
Study Completion (Estimated)
June 24, 2025
Study Registration Dates
First Submitted
July 1, 2024
First Submitted That Met QC Criteria
July 8, 2024
First Posted (Actual)
July 9, 2024
Study Record Updates
Last Update Posted (Actual)
July 9, 2024
Last Update Submitted That Met QC Criteria
July 8, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- soh-med-24-6-16MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.