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

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Infantile Hepatitis Syndrome; Neonatal Cholestasis; Biliary Atresia

Treatments: Diagnostic Test: biliary atresia screen score

Study type: Observational

Funder types: Other

Identifiers

NCT03842150

XH-19-001

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 1 day to 3 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

400 participants in 2 patient groups

derivation cohort

Treatment:

Diagnostic Test: biliary atresia screen score

validation cohort

Treatment:

Diagnostic Test: biliary atresia screen score