Dry Blood Spot Screening Test for Biliary Atresia（DBS-SCReBA）

Study Overview
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Brief Summary
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Our study aims to develop a screening test for biliary atresia (BA) using dry blood spot to improve patient survival by early diagnosis. Newborn screening dry blood spot will be examined for the direct bilirubin (DB), γ-GT or matrix metalloproteinase-7 (MMP-7) levels. These findings will promote early diagnosis for BA and hence improve the survival.

Detailed Description
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BA accounts for approximately 60% of the liver transplantations in infants younger than 1 year of age. The diagnosis of BA remains a clinical challenge because affected neonates have signs, symptoms, and serum liver biochemistry that are also seen in those with other causes of neonatal cholestasis. The success of the Kasai procedure is varied, but a good outcome is correlated with an early diagnosis. Unfortunately, most BA are usually identified later and the average age at surgery is about 60 days. To address this problem, some research groups screen infants for the pale stools or measure bilirubin level in the serum. However, these screening programs have not yet to be implemented because of several reasons. Recently, the relative abundance of serum MMP-7 was suggested to have discriminatory features for infants with BA. Nevertheless, whether the level of MMP-7 elevates in newborn dry blood spot of BA is still undefined. In this study, we will explore a screening strategy based on DB, γ-GT or MMP-7 measurement in newborn screening blood spot, and identify whether DB , γ-GT or MMP-7 measurement in the newborn period could be sensitive and specific for BA.

Official Title
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Dry Blood Spot Screening Test for Biliary Atresia and Other Cholestasis Diseases

Conditions
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Hepatobiliary Disease, Biliary Atresia, Neonatal Cholestasis

Intervention / Treatment
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* Diagnostic Test: Dry blood spot screening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Neonates born in Shanghai Exclusion Criteria: Subjects who do not agree with study protocol Subjects who join other clinical trials
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental：Dry blood spot screening<br> | Diagnostic Test: Dry blood spot screening<br>* Dry blood spot measurement of biomarker for screening biliary atresia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suspected BA | MMP-7 with or without other one or two biomarkers (DB and γ-GT) > upper limit of normal value | Three to Seven days after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry blood spot test, Biliary Atresia