NCT05196438

Brief 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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

January 15, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

January 19, 2022

Status Verified

January 1, 2022

Enrollment Period

12 months

First QC Date

January 3, 2022

Last Update Submit

January 18, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Interventions

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

Eligibility Criteria

Age1 Hour - 12 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • More than 12 years old .
  • Acquired heart diseases
  • Children with heart rate abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related 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.

    PMID: 24763516BACKGROUND
  • 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. doi: 10.1136/fn.70.1.f71. No abstract available.

    PMID: 8117134BACKGROUND
  • 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.

    PMID: 22078432BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Amr A Khedewy, resident

CONTACT

Mohamed A Bakhit, professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor at pediateric department sohag university hospital

Study Record Dates

First Submitted

January 3, 2022

First Posted

January 19, 2022

Study Start

January 15, 2022

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

January 19, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

Locations