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

Shanghai Jiao Tong University

Status: Unknown

Conditions: Neonatal Cholestasis; Hepatobiliary Disease; Biliary Atresia

Treatments: Diagnostic Test: Dry blood spot screening

Study type: Interventional

Funder types: Other

Identifiers

NCT03898765

XH-BA-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Neonates born in Shanghai

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20,000 participants in 1 patient group

Experimental：Dry blood spot screening

Experimental group

Treatment:

Diagnostic Test: Dry blood spot screening