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

Biliary Atresia Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Biliary Atresia
• Cholestasis
• Hepatobiliary Disease
• Neonatal Cholestasis

• NCT number: NCT03898765
• Study type: Interventional
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Wei Cai, Pro
• Phone: 0821-25076441
• Email: caiw204@sjtu.edu.cn
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2019
• Completion date: December 31, 2021