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NCT Number: NCT07247604

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

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.

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Key information

Conditions

Cholestasis Bile Duct Diseases Biliary Tract Diseases Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital Heart Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Heart Defects, Congenital Heart Diseases

Age range

1 month–2 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children below 2 years presenting with cholestasis

Exclusion criteria

  • Prematurely born infants.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Types of CHDs identified in cholestatic infants

    Time frame: During hospital evaluation

    At baseline echocardiographic assessment

Study contacts

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

Dalia Mahran

CONTACT

[email protected]

01007120821

‪Shimaa Ahmed‬

CONTACT

[email protected]

01120432073

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 25, 2025
Registry last updated
Nov 25, 2025

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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