Patterns of Congenital Heart Diseases at Sohag University Hospital

Congenital Heart Disease Clinical Trial

Official title:

Patterns of Congenital Heart Diseases at Sohag University Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05196438
• Other study ID #: Soh-Med-21-12-05
• Status: Not yet recruiting
• Start date: January 15, 2022
• Est. completion date: January 2023

Study information

• Verified date: January 2022
• Source: Sohag University
• Contact: Amr A Khedewy, resident
• Phone: 01112061113
• Email: amremam[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Congenital heart diseases (CHD) are structural or functional heart diseases that present at birth even if it is discovered later in life .

Congenital heart disease is caused by disturbance in the normal development of the heart especially during the first 6 weeks of pregnancy. Researchers aren't sure about the exact cause , but they think genetics , certain medical conditions , some medications and environmental factors, such as smoking, may play a role .

CHD in many cases may be asymptomatic and discovered accidently during the routine examination or may be presented by some clinical manifestations (e.g. Cyanosis or Murmers) and /or complications (e.g. Heart Failure Manifestations : Tachycardia , Tachypnea , Dyspnea during feeding , Diaphoresis especially during feeding

,Restlessness, irritability , Hepatomegaly , and Failure To Thrive) .

Recently diagnosis of congenital heart disease is better by using advanced technology e.g. echocardiography, magnetic resonance imaging (MRI), cardiac catheterization, angiography, and radio-active isotopes . and early diagnosis is very important as regard the manangement of the disease .

As medical care and surgical interventions have advanced over time, the treatment of many abnormalities is now available . and many infants and children with congenital heart defects are living longer and healthier lives. Many are living into adulthood, requiring ongoing, lifelong medical care for their conditions .

So information about different aspects of CHD is very important for planning health programs for long-term care and maintenance for these cases .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Gender: All
• Age group: N/A to 12 Years

Eligibility

Inclusion Criteria:

• All children from date of birth to age of 12 years old including both genders diagnosed to have CHD .

Exclusion Criteria:

• More than 12 years old .

• Acquired heart diseases

• Children with heart rate abnormalities

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Other:
• Collecting statistics about congenital heart patterns and investigations done and interventions done to them
Collecting statistics about congenital heart patterns and investigations done and treatment given or interventions e.g. catheterization or surgical operations done to them

Locations

Country	Name	City	State
Egypt	Sohag University Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Donofrio MT, Moon-Grady AJ, Hornberger LK, Copel JA, Sklansky MS, Abuhamad A, Cuneo BF, Huhta JC, Jonas RA, Krishnan A, Lacey S, Lee W, Michelfelder EC Sr, Rempel GR, Silverman NH, Spray TL, Strasburger JF, Tworetzky W, Rychik J; American Heart Association Adults With Congenital Heart Disease Joint Committee of the Council on Cardiovascular Disease in the Young and Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and Council on Cardiovascular and Stroke Nursing. Diagnosis and treatment of fetal cardiac disease: a scientific statement from the American Heart Association. Circulation. 2014 May 27;129(21):2183-242. doi: 10.1161/01.cir.0000437597.44550.5d. Epub 2014 Apr 24. Review. Erratum in: Circulation. 2014 May 27;129(21):e512. — View Citation

Silove ED. Assessment and management of congenital heart disease in the newborn by the district paediatrician. Arch Dis Child Fetal Neonatal Ed. 1994 Jan;70(1):F71-4. Review. — View Citation

van der Linde D, Konings EE, Slager MA, Witsenburg M, Helbing WA, Takkenberg JJ, Roos-Hesselink JW. Birth prevalence of congenital heart disease worldwide: a systematic review and meta-analysis. J Am Coll Cardiol. 2011 Nov 15;58(21):2241-7. doi: 10.1016/j.jacc.2011.08.025. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patterns of congenital heart disease	Recording of cases of congenital heart diseases with its patterns or types and recording The Management procedures done to them	one year
Primary	Incidence & Prevalence of Patterns of Congenital Heart Diseases in Sohag University Hospital	Recording Incidence and Prevalence of each Pattern of congenital heart diseases with its types for statistical purposes .	one year