Randomized, Double-Blinded, Placebo-Controlled Trial of Corticosteroid Therapy Following Portoenterostomy in Infants with Biliary Atresia (START)

START is a study to evaluate the usefulness of prednisone after surgery for biliary atresia.

The purpose of this national study is:

  • To determine whether perioperative treatment with corticosteroids imporves the outcome of infants following Kasai surgery and decreases serum bilirubin concentration after portoenterostomy
  • To determine whether corticosteroid treatment after portoenterostomy will improve outcomes as defined by survival without transplantation at 24 months of age
  • To determine whether corticosteroid treatment after portoenterostomy will improve growth of infants with biliary atresia
  • To determine whether corticosteroid treatment improves biochemical indicators of each of the fat-soluble vitamins after supplementation with standard doses
  • To determine whether corticosteroid treatment after portoenterostomy will decrease the incidence of persistent ascites or ascites that requires medical treatment

Eligibility Criteria

  • Portoenterostomy or gall bladder Kasai operation for biliary atresia within the previous 72 hours
  • Post-conception age = 36 weeks
  • Weight at enrollment = 2000 gm
  • Written informed consent obtained prior to or within 72 hours of completion of portoenterostomy (Note: families of potential subjects may be approached prior to the portoenterostomy)
  • Patients must receive their care and follow up at one of the ChiLDREN clinical centers

Requirements

Study participants will need to be enrolled in PROBE to be eligible for this study.

Participants will be randomly assigned in to one of two groups. One group will receive corticosteroids and the other will receive a placebo.The study medication will be prescribed for 13 weeks after Kasai surgery. Participants will make a series of visits for physical examinations and include collection of blood an urine samples as would normally happen in the course of their medical care. Visits are generally scheduled at 2 weeks, 1, 2, 3 and 6 months after diagnosis, and at 12, 18 and 24 months of age. Parents will keep a diary of the child’s condition during the study period.