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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07247604

Enrollment

106

Registered

2025-11-25

Start date

2025-12-11

Completion date

2026-12-20

Last updated

2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholestasis, Congenital Heart Disease

Brief summary

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.

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

1 Months to 2 Years

Healthy volunteers

Inclusion criteria

* Children below 2 years presenting with cholestasis

Exclusion criteria

* Prematurely born infants.

Design outcomes

Primary

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

Secondary

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

Contacts

Primary Contact‪Shimaa Ahmed‬

shimaa01120432073@gmail.com01120432073

Backup ContactDalia Mahran

daliaym2001@yahoo.com01007120821

Outcome results