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

Not Applicable

• Conditions: Neonatal Cholestasis; Biliary Atresia; Hepatobiliary Disease
• Interventions: Diagnostic Test: Dry blood spot screening

• Registration Number: NCT03898765
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

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

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.

Study Timeline

• Status Verified: 2019-03
• Study Start: 2019-04-01
• Study First Submitted: 2019-04-01
• Study First Submitted QC: 2019-04-01
• Last Update Submitted: 2019-04-01
• Study First Posted: 2019-04-02
• Last Update Posted: 2019-04-02
• Primary Completion: 2020-03-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

• Neonates born in Shanghai

Exclusion Criteria

• Subjects who do not agree with study protocol
• Subjects who join other clinical trials

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental：Dry blood spot screening	Dry blood spot screening	-

Primary Outcome Measures

Name	Time	Method
Suspected BA	Three to Seven days after birth	MMP-7 with or without other one or two biomarkers (DB and γ-GT) \> upper limit of normal value

Trial Locations

Locations (1)

Shanghai Xinhua Hospital, affiliated to Shanghai Jiao Tong University, School of Medicine; 🇨🇳 Shanghai, China