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

NCT ID: NCT03842150

Last Updated: 2022-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Biliary Atresia Neonatal Cholestasis Infantile Hepatitis Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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derivation cohort

biliary atresia screen score

Intervention Type DIAGNOSTIC_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.

validation cohort

biliary atresia screen score

Intervention Type DIAGNOSTIC_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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yongjun Zhang, doctor

Role: CONTACT

Phone: +8602125078310

Email: [email protected]

Facility Contacts

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Yongjun Zhang, doctor

Role: primary

Other Identifiers

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XH-19-001

Identifier Type: -

Identifier Source: org_study_id