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

NCT ID: NCT07247604

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-11

Study Completion Date

2026-12-20

Brief Summary

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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

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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.

Conditions

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Cholestasis Congenital Heart Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Children below 2 years presenting with cholestasis

Exclusion Criteria

* Prematurely born infants.
Minimum Eligible Age

1 Month

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Shimaa Ahmed Mahros

Resident, Family Medicine Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dalia Mahran Mohammed, Prof.

Role: STUDY_CHAIR

Professor of Family Medicine

Central Contacts

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‪Shimaa Ahmed‬

Role: CONTACT

01120432073

Dalia Mahran

Role: CONTACT

01007120821

Other Identifiers

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CHD-CHOLEST-ASSIUT

Identifier Type: -

Identifier Source: org_study_id

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