Congenital Heart Diseases and Developmental Assessment in Cholestatic Infants Under Two Years

November 22, 2025 updated by: Shimaa Ahmed Mahros, Assiut University

Pattern of Congenital Heart Diseases and Developmental Evaluation in Children Below Two Years With Cholestasis at Assiut University Children's Hospital

Congenital heart diseases (CHDs) are common in infants with cholestasis due to shared prenatal and metabolic factors. This study aims to determine the frequency and types of CHDs and to assess physical and mental development in children below two years with cholestasis at Assiut University Children's Hospital.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Congenital heart diseases (CHDs) are the most common structural malformations in childhood, affecting approximately 8-12 per 1,000 live births worldwide. Infants with systemic disorders such as neonatal and infantile cholestasis have a higher prevalence of CHDs due to overlapping prenatal insults, genetic syndromes, and metabolic disturbances. Cholestasis, defined as impaired bile flow with conjugated hyperbilirubinemia, may arise from biliary atresia, neonatal hepatitis, or metabolic and syndromic disorders such as Alagille syndrome. Several studies highlight a strong association between cholestasis and CHDs, and early recognition of this dual burden is essential to improve outcomes.

Study Type

Observational

Enrollment (Estimated)

106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Infants with various causes of cholestatic disorders evaluated for congenital heart diseases and developmental outcomes.

Description

Inclusion Criteria:

  • Children below 2 years presenting with cholestasis

Exclusion Criteria:

  • Prematurely born infants.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of CHDs among cholestatic infants
Time Frame: At initial clinical evaluation
Assessment of prevalence of congenital heart diseases in infants below 2 years with cholestasis.
At initial clinical evaluation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Types of CHDs identified in cholestatic infants
Time Frame: During hospital evaluation
At baseline echocardiographic assessment
During hospital evaluation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Dalia Mahran Mohammed, Prof., Professor of Family Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 11, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 20, 2026

Study Registration Dates

First Submitted

November 15, 2025

First Submitted That Met QC Criteria

November 22, 2025

First Posted (Actual)

November 25, 2025

Study Record Updates

Last Update Posted (Actual)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 22, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHD-CHOLEST-ASSIUT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared because the dataset contains sensitive clinical information about pediatric patients, and sharing is not permitted by the institutional ethics committee.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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