Development and Validation of a Screening Score for the Biliary Atresia in Infantile Cholestasis: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Development and Validation a Screening Score for the biliary atresia in infantile cholestasis
研究概览
简要总结
Better survival and prognosis of biliary atresia (BA) depend on early diagnosis and timely Kasai portoenterostomy. Identifying BA from other causes of infantile cholestasis at early stage of the disease still remains a major challenge. In this study, the investigators aim to develop and validate a scoring system to screen BA in infants with cholestasis.
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 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of neonatal cholestasis Age at first visit less than 90 days after birth
排除标准
- •Severe congenital malformation Subjects with missing data
结局指标
主要结局
Development and Validation a Screening Score for the biliary atresia in infantile cholestasis
时间窗: 1 weeks
Developed a scoring system according to clinical, laboratory, imaging features of BA and test it in the clinical work. The score system might including clay stool, γ-glutamyl transpeptadase, the results of ultrasound and subscales selected for logistic regression. The total score would sum all the subscales up.The investigators grade the patients with the cholestasis screen score to identify patients with biliary atresia. Patients with score ≤ 15 points considered to be the low-risk group, and patients with risk score \> 15 points considered the high-risk group, and the score model has no maximum or minimum value.
次要结局
未报告次要终点