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

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

Sponsors

Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Source Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Brief 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.

Overall Status Recruiting
Start Date June 1, 2014
Completion Date December 31, 2020
Primary Completion Date December 31, 2020
Study Type Observational
Primary Outcome
Measure Time Frame
Development and Validation a Screening Score for the biliary atresia in infantile cholestasis 1 weeks
Enrollment 400
Condition
Intervention

Intervention type: Diagnostic Test

Intervention name: biliary atresia screen score

Description: 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

Sampling method: Probability Sample

Criteria:

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

Gender: All

Minimum age: N/A

Maximum age: 3 Months

Healthy volunteers: Accepts Healthy Volunteers

Overall Contact

Last name: Yongjun Zhang, doctor

Phone: +8602125078310

Email: [email protected]

Location
facility status contact Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Yongjun Zhang, doctor
Location Countries

China

Verification Date

January 2019

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Arm group label: derivation cohort

Arm group label: validation cohort

Patient Data Undecided
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov