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临床试验/NCT07247604
NCT07247604尚未招募不适用

Pattern of Congenital Heart Diseases and Developmental Evaluation in Children Below Two Years With Cholestasis at Assiut University Children's Hospital

Assiut University0 个研究点目标入组 106 人开始时间: 2025年12月11日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
106
主要终点
Frequency of CHDs among cholestatic infants

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
1 Month 至 2 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children below 2 years presenting with cholestasis

排除标准

  • Prematurely born infants.

结局指标

主要结局

Frequency of CHDs among cholestatic infants

时间窗: At initial clinical evaluation

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

次要结局

  • Types of CHDs identified in cholestatic infants(During hospital evaluation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shimaa Ahmed Mahros

Resident, Family Medicine Department

Assiut University

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