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Not yet recruiting NCT07373873

Growth in Infants With Congenital Heart Disease at AUCH

Observational Congenital Heart Disease (CHD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Congenital Heart Disease (CHD). Basic parameters: 1 months — 2 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Assessment of Growth in Children With Congenital Heart Disease in Assuit University Children Hospital

Overview

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.

Primary outcome measures

  • 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).]

Eligibility criteria

Inclusion criteria

  • Children aged 1 month to 2 years.
  • Diagnosis of congenital heart disease (CHD) confirmed by echocardiography.
  • Availability of anthropometric data in the medical record.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Egypt · 2 centers
  • Assuit University Children Hospital - Cardiology Department — Asyut
  • Assuit University Children Hospital — Asyut

Identifiers

NCT: NCT07373873 · FMASU-PED-CHD-Growth-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗