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NCT Number: NCT07373873

Growth in Infants With Congenital Heart Disease at AUCH

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.

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Key information

Age range

1 month–2 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Assuit University Children Hospital, Asyut, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amr Mo Kotb, Lecturer

CONTACT

[email protected]

01001936031

Lamiaa Mo Hussein, Resident

CONTACT

[email protected]

01025347563 ext. 01030893340

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Acronym: CHD-Growth

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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