NCT07247604

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
• Phase: —
• Study type: Observational
• Enrollment: 106 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 1 Month – 2 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cholestasis
• Congenital Heart Disease

Timeline

• Start date: 2025-12-11
• Primary completion: 2026-12-01
• Completion: 2026-12-20
• First posted: 2025-11-25
• Last updated: 2025-11-25