Congenital Heart DefectsNCT06124443
Congenital Heart Defects
An observational study of Congenital Heart Defects, run by Assiut University.
Trial summary
Describe the relationship between maternal diabetes and congenital heart defects in infants born to diabetic mothers referred to NICU unit \& Outpatient clinics of Assiut University Childeren's hospital.We will compare between 2 groups. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Congenital Heart Defects
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 31 May 2026
- 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 day to 18 years
- All sexes
- Child, Adult
Study population: Neonates and children of diabetic and non-diabetic mothers
Who may be able to join
- The study will include infants of diabetic mothers and infants of non-diabetic mothers not previously screened for congenital heart defects.
Who cannot join
- Other risk factors for congenital heart defects including congenital infections like TORCH infection, teratogenic drugs ( lithium or isotretinoin), , alcohol, or smoking.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Maternal Diabetes as a Risk Factor for Congenital Heart Defects in Infants of Diabetic Mothers.
Describe the relationship between maternal diabetes and congenital heart defects in infants born to diabetic mothers referred to NICU unit \& Outpatient clinics of Assiut University Childeren's hospital.We will compare between 2 groups. Cases will represent infants of diabetic mothers \& Conteols will represent infants of non-diabetic mothers.
Read the detailed description
Congenital heart disease is defined as a gross structural abnormality of the heart or intra-thoracic great vessels that is actually or potentially of functional significance .The prevalence of CHD at birth has been relatively variable at 4.05 to 10.4 cases per 1000 live births in different surveys however,it is 5.0% in infants of diabetic mothers (IDMs).CHD is the most common congenital problem in children accounting for nearly 25% of all congenital malformations .CHDs are one of the significant causes of infant morbidity and mortality. Gestational diabetes mellitus (GDM) is the most common medical complication of pregnancy. It is associated with maternal and neonatal adverse outcomes. Maintaining adequate blood glucose levels in GDM reduces morbidity for both mother and baby. Pregnancy is associated with insulin resistance (IR) and hyperinsulinemia that may predispose some women to develop diabetes. Gestational diabetes has been defined as any degree of glucose intolerance with an onset, or first recognition during pregnancy. Diabetes during pregnancy could be a de novo that arises during pregnancy for the first time and could disappear or persist after delivery (gestational DM) or could start as pre-gestational, before the onset of pregnancy. The incidence of impaired glucose tolerance in pregnancy ranges between 3-10% and varies according to the average incidence of diabetes in the general Population. Specific CHDs that are more commonly seen in IDMs include ventricular septal defect (VSD), transposition of the great arteries (TGAs), and aortic stenosis (AS).Approximately one third of neonates with CHD require intervention in the first month of life . Clinical manifestation of CHD varies according to the type of lesion. Neonates with respiratory distress , cyanosis, feeding difficulties, and low cardiac output are common presentations of CHD . So diagnosis of CHD at the earliest possible time is very important as early referral and appropriate intervention in some of these cases are lifesaving.
- Conditions
- Congenital Heart Defects
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Infants \& children of diabetic mothers | |
| Controls | Infants \& children of non-diabetic mothers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assesment of prevalence of congenital heart defects among infants of diabetic mother compared to that in infants of non-diabetic mothers.
Assesment of prevalence of congenital heart defects among infants of diabetic mother compared to that in infants of non-diabetic mothers.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start1 Dec 2024 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion31 May 2026 (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 DefectsStudies of the same condition, open and under way.
- More trials run by Assiut 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-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moustafa Adel Mohamed Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124443
- Sponsor's protocol ID
- Congenital heart defects
- Status last verified
- Nov 2023
- First submitted
- 5 Nov 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Al-Biltagi M, Tolba OA, Rowisha MA, Mahfouz Ael-S, Elewa MA. Speckle tracking and myocardial tissue imaging in infant of diabetic mother with gestational and pregestational diabetes. Pediatr Cardiol. 2015 Feb;36(2):445-53. doi: 10.1007/s00246-014-1033-0. Epub 2014 Oct 7.
PubMed 25287219Classification and diagnosis of diabetes mellitus and other categories of glucose intolerance. National Diabetes Data Group. Diabetes. 1979 Dec;28(12):1039-57. doi: 10.2337/diab.28.12.1039. No abstract available.
PubMed 510803Aburawi EH. The burden of congenital heart disease in libya. Libyan J Med. 2006 Sep 8;1(2):120-2. doi: 10.4176/060902. No abstract available.
PubMed 21526009
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Diabetes as a Risk Factor for Congenital Heart Defects in Infants of Diabetic Mothers.
- ClinicalTrials.gov ID
- NCT06124443
- Acronym / sponsor ID
- Congenital heart defects
- Conditions
- Congenital Heart Defects
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 9 Nov 2023 (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.
Describe the relationship between maternal diabetes and congenital heart defects in infants born to diabetic mothers referred to NICU unit \& Outpatient clinics of Assiut University Childeren's hospital.We will compare between 2 groups. Cases will represent infants of diabetic mothers \& Conteols will represent infants of non-diabetic mothers.
Detailed description
Congenital heart disease is defined as a gross structural abnormality of the heart or intra-thoracic great vessels that is actually or potentially of functional significance .The prevalence of CHD at birth has been relatively variable at 4.05 to 10.4 cases per 1000 live births in different surveys however,it is 5.0% in infants of diabetic mothers (IDMs).CHD is the most common congenital problem in children accounting for nearly 25% of all congenital malformations .CHDs are one of the significant causes of infant morbidity and mortality. Gestational diabetes mellitus (GDM) is the most common medical complication of pregnancy. It is associated with maternal and neonatal adverse outcomes. Maintaining adequate blood glucose levels in GDM reduces morbidity for both mother and baby. Pregnancy is associated with insulin resistance (IR) and hyperinsulinemia that may predispose some women to develop diabetes. Gestational diabetes has been defined as any degree of glucose intolerance with an onset, or first recognition during pregnancy. Diabetes during pregnancy could be a de novo that arises during pregnancy for the first time and could disappear or persist after delivery (gestational DM) or could start as pre-gestational, before the onset of pregnancy. The incidence of impaired glucose tolerance in pregnancy ranges between 3-10% and varies according to the average incidence of diabetes in the general Population. Specific CHDs that are more commonly seen in IDMs include ventricular septal defect (VSD), transposition of the great arteries (TGAs), and aortic stenosis (AS).Approximately one third of neonates with CHD require intervention in the first month of life . Clinical manifestation of CHD varies according to the type of lesion. Neonates with respiratory distress , cyanosis, feeding difficulties, and low cardiac output are common presentations of CHD . So diagnosis of CHD at the earliest possible time is very important as early referral and appropriate intervention in some of these cases are lifesaving.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Infants \& children of diabetic mothers |
| Controls | – | –Infants \& children of non-diabetic mothers |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Neonates and children of diabetic and non-diabetic mothers
Key inclusion criteria (1 listed)
- The study will include infants of diabetic mothers and infants of non-diabetic mothers not previously screened for congenital heart defects.
Key exclusion criteria (1 listed)
- Other risk factors for congenital heart defects including congenital infections like TORCH infection, teratogenic drugs ( lithium or isotretinoin), , alcohol, or smoking.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assesment of prevalence of congenital heart defects among infants of diabetic mother compared to that in infants of non-diabetic mothers.
Time frame: Baseline
Assesment of prevalence of congenital heart defects among infants of diabetic mother compared to that in infants of non-diabetic mothers.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Background: PubMed 25287219Al-Biltagi M, Tolba OA, Rowisha MA, Mahfouz Ael-S, Elewa MA. Speckle tracking and myocardial tissue imaging in infant of diabetic mother with gestational and pregestational diabetes. Pediatr Cardiol. 2015 Feb;36(2):445-53. doi: 10.1007/s00246-014-1033-0. Epub 2014 Oct 7.
- Background: PubMed 510803Classification and diagnosis of diabetes mellitus and other categories of glucose intolerance. National Diabetes Data Group. Diabetes. 1979 Dec;28(12):1039-57. doi: 10.2337/diab.28.12.1039. No abstract available.
- Background: PubMed 21526009Aburawi EH. The burden of congenital heart disease in libya. Libyan J Med. 2006 Sep 8;1(2):120-2. doi: 10.4176/060902. No abstract available.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Defects, run by Assiut University.
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 1 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 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Moustafa Adel Mohamed Ahmed (+201123248863, dr.mostafaaboelsoud2020@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assesment of prevalence of congenital heart defects among infants of diabetic mother compared to that in infants of non-diabetic mothers. (time frame: Baseline). 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 NCT06124443, 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 9 Nov 2023; AzTrials last refreshed its copy on 2 Nov 2026.