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
1 other identifier
observational
106
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2025
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2025
CompletedFirst Posted
Study publicly available on registry
November 25, 2025
CompletedStudy Start
First participant enrolled
December 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 20, 2026
November 25, 2025
November 1, 2025
12 months
November 15, 2025
November 22, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Frequency of CHDs among cholestatic infants
Assessment of prevalence of congenital heart diseases in infants below 2 years with cholestasis.
At initial clinical evaluation
Secondary Outcomes (1)
Types of CHDs identified in cholestatic infants
During hospital evaluation
Eligibility Criteria
Infants with various causes of cholestatic disorders evaluated for congenital heart diseases and developmental outcomes.
You may qualify if:
- Children below 2 years presenting with cholestasis
You may not qualify if:
- Prematurely born infants.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Dalia Mahran Mohammed, Prof.
Professor of Family Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident, Family Medicine Department
Study Record Dates
First Submitted
November 15, 2025
First Posted
November 25, 2025
Study Start
December 11, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 20, 2026
Last Updated
November 25, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share
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.