START: A randomized double-blinded, placebo-controlled trial of corticosteroid therapy following portoenterostomy in infants with biliary atresia

What is the purpose of the steroid trial?

The purpose of the START clinical trial is to determine whether or not infants with biliary atresia (BA) have a better outcome when steroids are used for 3 months following the Kasai operation.

What will be done?

A child with biliary atresia will be placed by chance into either the group getting steroids or the placebo group. The child will also receive 5 additional medications that are routinely prescribed to patients with biliary atresia; these medications will be provided free of charge for the length of the study or until no longer needed. Routine follow up will be done up to 2 years of age. At one and two years of age the child will undergo developmental testing.

Who can enroll?

Infants up to 6 months of age diagnosed with biliary atresia (BA) (blockage of bile flow) who are enrolled in the BARC prospective study of cholestatic disease (PROBE).

How long does the study last?

Unitil the child is two years of age; there are 8 clinic visits during the study.

Who can I call if I have questions?

BARC Contact Information

THANK YOU FOR YOUR INTEREST IN THIS STUDY