NCT07373873

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
10mo left

Started Mar 2026

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
Mar 2026May 2027

First Submitted

Initial submission to the registry

January 16, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 16, 2026

Last Update Submit

January 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    At study enrollment (data extracted from medical records for age points 6, 12, and 18 months where available).

Study Arms (1)

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.

Eligibility Criteria

Age1 Month - 2 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsThe study involves analysis of existing medical records. Eligibility for data inclusion is based on the biological sex (male or female) recorded in the patient's file at the time of clinical care, as growth reference standards are sex-specific. The study does not involve prospective recruitment where self-identified gender would be assessed.
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Assuit University Children Hospital - Cardiology Department

Asyut, 71515, Egypt

Location

Assuit University Children Hospital

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Emad-Eldeen Mahmoud Hammad mo Hammad, prof

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Lamiaa Mo Hussein, Resident

CONTACT

Amr Mo Kotb, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor at Al-Mabrah Hospital

Study Record Dates

First Submitted

January 16, 2026

First Posted

January 28, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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

Locations