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
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.
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.
150 studies on the registry are indexed under Cholestasis; 18 are open to participants now.
This study's planned enrollment of 106 is above the median of 95 across 36 observational studies indexed under Cholestasis.
Browse Cholestasis studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Infants with various causes of cholestatic disorders evaluated for congenital heart diseases and developmental outcomes.
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Exclusion Criteria:
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
Types of CHDs identified in cholestatic infants
At baseline echocardiographic assessment
Time frame: During hospital evaluation
No study locations are listed for this record.
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.
Start is estimated for Dec 2025; primary completion for Dec 2026, 11 months later.
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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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