Congenital Heart DiseaseNCT05196438
Patterns of Congenital Heart Diseases at Sohag University Hospital
An observational study of Congenital Heart Disease, run by Sohag University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 1 hour to 12 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Collecting statistics about congenital heart patterns and investigations done and interventions done to them
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2022to Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 12 years
- All sexes
- Child
Study population: All children from date of birth to age of 12 years old including both genders diagnosed to have CHD .
Who may be able to join
- All children from date of birth to age of 12 years old including both genders diagnosed to have CHD .
Who cannot join
- More than 12 years old .
- Acquired heart diseases
- Children with heart rate abnormalities
Trial locations and contacts
1 site in 1 country.
Mohamed A Bakhit, professor contact
About this study
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 .
Read more
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 .
- Conditions
- Congenital Heart Disease
- Being tested
- Collecting statistics about congenital heart patterns and investigations done and interventions done to them
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collecting statistics about congenital heart patterns and investigations done and interventions done to themOther
Collecting statistics about congenital heart patterns and investigations done and treatment given or interventions e.g. catheterization or surgical operations done to them
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 .
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start15 Jan 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Abdelnaeem Khedewy, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196438
- Sponsor's protocol ID
- Soh-Med-21-12-05
- Status last verified
- Jan 2022
- First submitted
- 3 Jan 2022
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 24763516Silove 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.
PubMed 8117134van 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.
PubMed 22078432
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns of Congenital Heart Diseases at Sohag University Hospital
- ClinicalTrials.gov ID
- NCT05196438
- Acronym / sponsor ID
- Soh-Med-21-12-05
- Conditions
- Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Jan 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 hour to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- All children from date of birth to age of 12 years old including both genders diagnosed to have CHD .
Key inclusion criteria (1 listed)
- All children from date of birth to age of 12 years old including both genders diagnosed to have CHD .
Key exclusion criteria (3 listed)
- More than 12 years old .
- Acquired heart diseases
- Children with heart rate abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collecting statistics about congenital heart patterns and investigations done and interventions done to themCollecting statistics about congenital heart patterns and investigations done and treatment given or interventions e.g. catheterization or surgical operations done to them | Other | – |
Primary outcome
Patterns of congenital heart disease
Time frame: one year
Recording of cases of congenital heart diseases with its patterns or types and recording The Management procedures done to them
Incidence & Prevalence of Patterns of Congenital Heart Diseases in Sohag University Hospital
Time frame: one year
Recording Incidence and Prevalence of each Pattern of congenital heart diseases with its types for statistical purposes .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Background: PubMed 24763516Donofrio 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.
- Background: PubMed 8117134Silove 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.
- Background: PubMed 22078432van 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed A Bakhit, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr A Khedewy, resident (01112061113, amremam@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patterns of congenital heart disease (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05196438, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2022.