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Not yet recruitingNCT07247604Updated Nov 25, 2025

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

An observational study in Cholestasis and Congenital Heart Disease, sponsored by Assiut University. Not yet recruiting. Open to participants aged 1 Month to 2 Years. Per ClinicalTrials.gov, last updated 2025-11-25.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
106
Ages
1 Month to 2 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Cholestasis
  • Congenital Heart Disease
03

Who can participate

Ages eligible
1 Month to 2 Years
Sexes eligible
All
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.

Inclusion criteria

  • Children below 2 years presenting with cholestasis

Exclusion criteria

Exclusion Criteria:

  • Prematurely born infants.
04

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
106 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Frequency of CHDs among cholestatic infants

    Assessment of prevalence of congenital heart diseases in infants below 2 years with cholestasis.

    Time frame: At initial clinical evaluation

Secondary outcomes

  1. Types of CHDs identified in cholestatic infants

    At baseline echocardiographic assessment

    Time frame: During hospital evaluation

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07247604
Lead sponsor
Assiut University
Responsible party
Shimaa Ahmed Mahros (Resident, Family Medicine Department, Assiut University) — Principal investigator
First posted
Nov 25, 2025
Start date
Dec 11, 2025 (estimated)
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 20, 2026 (estimated)
Last update
Nov 25, 2025

Study contacts

‪Shimaa Ahmed‬
Contact
shimaa01120432073@gmail.com
01120432073
Dalia Mahran
Contact
daliaym2001@yahoo.com
01007120821
Dalia Mahran Mohammed, Prof.
study chair · Professor of Family Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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