跳至主要内容
临床试验/NCT07139717
NCT07139717尚未招募不适用

Evaluation of the Effectiveness of Stool Color Card in the Early Detection of Biliary Atresia: A Prospective Study.

Assiut University0 个研究点目标入组 100 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Effectiveness of Stool Color Card in Early Detection of Biliary Atresia

研究概览

简要总结

To evaluate the effectiveness of using a stool color card as a non-invasive screening tool for the early detection of biliary atresia, with the objective of improving early diagnosis rates and facilitating timely surgical intervention.

详细描述

Biliary atresia (BA) is a rare but life-threatening liver disorder that affects infants, characterized by the progressive inflammation and fibrosis of the bile ducts, leading to biliary obstruction [1].

Early diagnosis and intervention are crucial - ideally before 60 days of age - as BA is a leading cause of liver transplantation in children if not diagnosed and treated promptly [2]. The traditional method of diagnosis involves the identification of clinical signs like jaundice and abnormal liver function tests, but this approach can delay the diagnosis, leading to irreversible liver damage. As a result, early detection is essential to improve outcomes and prevent the need for a liver transplant [3].

The stool color card (SCC) is a diagnostic tool that has gained significant attention in recent years as a non-invasive method for the early detection of biliary atresia [4]. Newborns with biliary atresia typically exhibit pale stools due to a lack of bile secretion [5].

The stool color card provides a simple way for parents or healthcare professionals to monitor changes in the stool color in newborns, providing an early indicator of potential biliary atresia [6,7]. The card features a range of colors that correspond to the different stages of stool color, allowing for easy comparison and identification of abnormal stool [8-11].

Despite the availability of SCCs, their effectiveness in routine screening programs remains understudied. There is a need to evaluate the utility of SCCs in improving early diagnosis rates of BA.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Day 至 90 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Neonates and infants aged 1-90 days old.
  • Neonates and infants with direct (conjugated) hyperbilirubinemia (Conjugated hyperbilirubinemia is generally defined as a conjugated or direct bilirubin level greater than 1 mg/dL when the total bilirubin is less than 5 mg/dL or more than 20% of the total bilirubin if the total bilirubin is greater than 5 mg/dL) [12]
  • No contraindication for liver biopsy as considered the gold standard for diagnosis of biliary atresia e.g. coagulopathy.

排除标准

  • 1 - Infants diagnosed with biliary atresia or other cholestatic liver diseases prior to enrollment.
  • 2-Infants aged more than 90 days 3-Neonates and infants with indirect hyperbilirubinemia. 4-Those with contraindication to do liver biopsy

结局指标

主要结局

Effectiveness of Stool Color Card in Early Detection of Biliary Atresia

时间窗: First 3 months

Diagnostic accuracy of the stool color card for early detection of biliary atresia (BA). Accuracy will be evaluated by sensitivity (proportion of BA cases detected), specificity (proportion of healthy infants correctly identified as not having BA), positive predictive value (PPV), and negative predictive value (NPV), compared to the reference standard of final diagnosis confirmed by imaging or surgery.

次要结局

未报告次要终点

研究者

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

Ahmed Hassan Hamed Ahmed

Principal Investigator

Assiut University

相似试验