NCT03842150

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 1 Day – 3 Months
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Biliary Atresia
• Neonatal Cholestasis
• Infantile Hepatitis Syndrome

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	biliary atresia screen score	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.

Timeline

• Start date: 2014-06-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2019-02-15
• Last updated: 2022-12-28

Locations

1 site across 1 country: China