Cholestasis Clinical Trial
OBJECTIVES: I. Compare conjugated bilirubin levels and serum bile acid levels in severely
premature newborns on long term parenteral nutrition and given either sincalide or placebo.
II. Compare morbidity and mortality rates in this patient population. III. Evaluate
ultrasonographic images of the hepatobiliary tree during and 1 to 2 years after the
administration of sincalide or placebo to assess the development of biliary sludge and
biliary stone formation.
PROTOCOL OUTLINE: This is a randomized, placebo controlled, double blind, multicenter study.
Patients are stratified according to prematurity or surgical group.
Patients are randomized to receive either placebo or sincalide IV over 10 to 15 minutes
every 12 hours until a total of 8 weeks of therapy is administered or greater than 50% of
their nutrition is enteral.
Patients are followed for a maximum of 2 years.
Completion date provided represents the completion date of the grant per OOPD records
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
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