Congenital Heart Disease (CHD)CHD-GrowthNCT07373873
Growth in Infants With Congenital Heart Disease at AUCH
An observational study of Congenital Heart Disease (CHD), run by Assiut University at 2 sites in Egypt.
Trial summary
Children with congenital heart disease (CHD) often experience growth problems. This study aims to assess and compare the growth (weight, height, head circumference) of infants and children with CHD against the expected growth standards for healthy children. Read more about this study
- Who is it for?
- Ages 1 month to 2 years
- Conditions the study is for
- Congenital Heart Disease (CHD)
- How many people
- 72 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Mar 2026to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 month to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: The study population consists of infants and young children (aged 1 month to 2 years) who were diagnosed with congenital heart disease (CHD) by echocardiography and were followed at the Pediatric Cardiology Unit of Assiut University Children Hospital. This is a retrospective cohort; participants are identified through a review of existing hospital medical records. The population includes patients with various types of CHD (both cyanotic and acyanotic) who have not yet undergone corrective cardiac surgery or intervention.
Who may be able to join
- Children aged 1 month to 2 years.
- Diagnosis of congenital heart disease (CHD) confirmed by echocardiography.
- Availability of anthropometric data in the medical record.
Who cannot join
- Presence of a known genetic syndrome or major extracardiac anomalies.
- Pre-existing endocrine or metabolic disorder affecting growth.
- Preterm birth (gestational age <37 weeks).
- Previous surgical/interventional procedure for CHD.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites
Assuit University Children Hospital - Cardiology Department
Asyut, 71515
Assuit University Children Hospital
Asyut, 71515
About this study
Official title: Assessment of Growth in Children With Congenital Heart Disease in Assuit University Children Hospital
Children with congenital heart disease (CHD) often experience growth problems. This study aims to assess and compare the growth (weight, height, head circumference) of infants and children with CHD against the expected growth standards for healthy children. This is a retrospective study that will review the medical records of children aged 1 month to 2 years who were diagnosed with CHD at Assiut University Children Hospital. The study will help understand how different types of CHD affect a child's growth, which is important for improving their nutritional care and overall management.
Read the detailed description
Background:
Congenital heart disease (CHD) is the most common type of congenital anomaly and a leading cause of morbidity in children. Despite advances in medical and surgical care, growth retardation remains a frequent comorbidity in this population. The pathophysiology of growth failure differs between cyanotic and acyanotic CHD, involving factors such as chronic hypoxemia, increased metabolic demands, feeding difficulties, and congestive heart failure. A detailed assessment of growth patterns in children with CHD is crucial for optimizing nutritional interventions, determining the timing of surgical repair, and improving long-term outcomes.
Objective:
The primary objective of this study is to define the impact of congenital heart disease on the somatic growth of infants and children. This will be achieved by comparing anthropometric parameters (weight, height/length, and head circumference) of patients with CHD to established growth standards for healthy children.
Study Design:
This is a retrospective, comparative cohort study. Data will be collected from the existing medical records of patients followed at the Pediatric Cardiology Unit of Assiut University Children Hospital.
Participants:
The study group will include children aged 1 month to 2 years who have been diagnosed with CHD by echocardiography. Patients with known genetic syndromes (e.g., Down syndrome), major extracardiac anomalies, pre-existing endocrine or metabolic disorders affecting growth, preterm birth history, or those who have already undergone surgical or interventional procedures for their CHD will be excluded.
Methods:
For each eligible child, the following data will be extracted from the medical records:
Demographic Information: Age, sex, and residence.
Anthropometric Measurements: Weight, height/length, and head circumference recorded during hospital visits.
Clinical Data: Specific type of CHD (classified as cyanotic or acyanotic), history of hospitalizations, and other relevant clinical notes.
Growth Assessment: Anthropometric data will be assessed at key age points (6, 12, and 18 months) where available.
Statistical Analysis:
Data analysis will be performed using SPSS version 26. Continuous variables will be presented as mean ± standard deviation, and categorical variables as frequencies and percentages. Growth parameters of the CHD cohort will be compared to standard population norms using appropriate statistical tests (e.g., one-sample t-test). Comparisons between cyanotic and acyanotic groups will be conducted using independent samples t-test or Mann-Whitney U test, as applicable. A p-value of less than 0.05 will be considered statistically significant.
Ethical Considerations:
The study protocol has been approved by the Ethics of Scientific Research Committee, Faculty of Medicine, Assiut University. The research involves the analysis of existing, anonymized data from medical records.
- Conditions
- Congenital Heart Disease (CHD)
- 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 |
|---|---|---|
| CHD Group | Infants and children aged 1 month to 2 years who were diagnosed with congenital heart disease (CHD) by echocardiography at Assiut University Children Hospital. This is a retrospective cohort; data on anthropometric measurements (weight, height/length, head circumference), type of CHD (cyanotic vs. acyanotic), and clinical history are collected from existing medical records. The growth parameters of this cohort will be compared against standard WHO or Egyptian growth reference charts to assess the impact of CHD on somatic growth. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight-for-age z-score in children with congenital heart disease
Comparison of the mean weight-for-age z-score in children with congenital heart disease (CHD) against the standard population mean (z-score = 0) using WHO or Egyptian growth reference charts.
Measured: At study enrollment (data extracted from medical records for age points 6, 12, and 18 months where available).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease (CHD)Studies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lamia Mohammed Hussain Mohammed, Assiut University
- Investigators
- Emad-Eldeen Mahmoud Hammad mo Hammad, prof, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373873
- Sponsor's protocol ID
- FMASU-PED-CHD-Growth-001
- Acronym
- CHD-Growth
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) that underlie the published aggregated results will not be publicly deposited due to patient confidentiality and institutional data policies. However, de-identified data may be made available to qualified researchers upon reasonable request, subject to review and approval by the principal investigator and the Ethics Committee of Assiut University Faculty of Medicine. Requestors will need to provide a methodologically sound proposal and sign a data use agreement
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Growth in Children With Congenital Heart Disease in Assuit University Children Hospital
- ClinicalTrials.gov ID
- NCT07373873
- Acronym / sponsor ID
- CHD-Growth / FMASU-PED-CHD-Growth-001
- Conditions
- Congenital Heart Disease (CHD)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 28 Jan 2026 (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.
Children with congenital heart disease (CHD) often experience growth problems. This study aims to assess and compare the growth (weight, height, head circumference) of infants and children with CHD against the expected growth standards for healthy children. This is a retrospective study that will review the medical records of children aged 1 month to 2 years who were diagnosed with CHD at Assiut University Children Hospital. The study will help understand how different types of CHD affect a child's growth, which is important for improving their nutritional care and overall management.
Detailed description
Background:
Congenital heart disease (CHD) is the most common type of congenital anomaly and a leading cause of morbidity in children. Despite advances in medical and surgical care, growth retardation remains a frequent comorbidity in this population. The pathophysiology of growth failure differs between cyanotic and acyanotic CHD, involving factors such as chronic hypoxemia, increased metabolic demands, feeding difficulties, and congestive heart failure. A detailed assessment of growth patterns in children with CHD is crucial for optimizing nutritional interventions, determining the timing of surgical repair, and improving long-term outcomes.
Objective:
The primary objective of this study is to define the impact of congenital heart disease on the somatic growth of infants and children. This will be achieved by comparing anthropometric parameters (weight, height/length, and head circumference) of patients with CHD to established growth standards for healthy children.
Study Design:
This is a retrospective, comparative cohort study. Data will be collected from the existing medical records of patients followed at the Pediatric Cardiology Unit of Assiut University Children Hospital.
Participants:
The study group will include children aged 1 month to 2 years who have been diagnosed with CHD by echocardiography. Patients with known genetic syndromes (e.g., Down syndrome), major extracardiac anomalies, pre-existing endocrine or metabolic disorders affecting growth, preterm birth history, or those who have already undergone surgical or interventional procedures for their CHD will be excluded.
Methods:
For each eligible child, the following data will be extracted from the medical records:
Demographic Information: Age, sex, and residence.
Anthropometric Measurements: Weight, height/length, and head circumference recorded during hospital visits.
Clinical Data: Specific type of CHD (classified as cyanotic or acyanotic), history of hospitalizations, and other relevant clinical notes.
Growth Assessment: Anthropometric data will be assessed at key age points (6, 12, and 18 months) where available.
Statistical Analysis:
Data analysis will be performed using SPSS version 26. Continuous variables will be presented as mean ± standard deviation, and categorical variables as frequencies and percentages. Growth parameters of the CHD cohort will be compared to standard population norms using appropriate statistical tests (e.g., one-sample t-test). Comparisons between cyanotic and acyanotic groups will be conducted using independent samples t-test or Mann-Whitney U test, as applicable. A p-value of less than 0.05 will be considered statistically significant.
Ethical Considerations:
The study protocol has been approved by the Ethics of Scientific Research Committee, Faculty of Medicine, Assiut University. The research involves the analysis of existing, anonymized data from medical records.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHD Group | – | –Infants and children aged 1 month to 2 years who were diagnosed with congenital heart disease (CHD) by echocardiography at Assiut University Children Hospital. This is a retrospective cohort; data on anthropometric measurements (weight, height/length, head circumference), type of CHD (cyanotic vs. acyanotic), and clinical history are collected from existing medical records. The growth parameters of this cohort will be compared against standard WHO or Egyptian growth reference charts to assess the impact of CHD on somatic growth. |
Who may qualify
- Ages
- 1 month to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population consists of infants and young children (aged 1 month to 2 years) who were diagnosed with congenital heart disease (CHD) by echocardiography and were followed at the Pediatric Cardiology Unit of Assiut University Children Hospital. This is a retrospective cohort; participants are identified through a review of existing hospital medical records. The population includes patients with various types of CHD (both cyanotic and acyanotic) who have not yet undergone corrective cardiac surgery or intervention.
Key inclusion criteria (3 listed)
- Children aged 1 month to 2 years.
- Diagnosis of congenital heart disease (CHD) confirmed by echocardiography.
- Availability of anthropometric data in the medical record.
Key exclusion criteria (4 listed)
- Presence of a known genetic syndrome or major extracardiac anomalies.
- Pre-existing endocrine or metabolic disorder affecting growth.
- Preterm birth (gestational age <37 weeks).
- Previous surgical/interventional procedure for CHD.
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
Weight-for-age z-score in children with congenital heart disease
Time frame: At study enrollment (data extracted from medical records for age points 6, 12, and 18 months where available).
Comparison of the mean weight-for-age z-score in children with congenital heart disease (CHD) against the standard population mean (z-score = 0) using WHO or Egyptian growth reference charts.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) that underlie the published aggregated results will not be publicly deposited due to patient confidentiality and institutional data policies. However, de-identified data may be made available to qualified researchers upon reasonable request, subject to review and approval by the principal investigator and the Ethics Committee of Assiut University Faculty of Medicine. Requestors will need to provide a methodologically sound proposal and sign a data use agreement
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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.
Emad-Eldeen Mahmoud Hammad mo Hammad, prof study director
Assiut University
2 sites 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 (CHD), run by Assiut University at 2 sites 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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lamiaa Mo Hussein, Resident (01025347563 ext. 01030893340, tahaishaq27@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight-for-age z-score in children with congenital heart disease (time frame: At study enrollment (data extracted from medical records for age points 6, 12, and 18 months where available).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2026.