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

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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

Trial contacts and locations

1

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Central trial contact

Yongjun Zhang, doctor

Data sourced from clinicaltrials.gov

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