Development and Validation of a Screening Score for the Biliary Atresia in Infantile Cholestasis: A Prospective Study

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine400 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

Biliary Atresia Neonatal Cholestasis Infantile Hepatitis Syndrome

Interventions

biliary atresia screen scoreDIAGNOSTIC_TEST

The investigators aim to develop a scoring system according to clinical, laboratory, imaging features of biliary atresia in the derivation dataset and tested in the validation datasets.

Eligibility

Sex: ALLMin age: 1 DayMax age: 3 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Clinical diagnosis of neonatal cholestasis Age at first visit less than 90 days after birth Exclusion Criteria: Severe congenital malformation Subjects with missing data

Outcomes

Primary Outcomes

Development and Validation a Screening Score for the biliary atresia in infantile cholestasis

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.

Time frame: 1 weeks