NCT00004414

Sincalide (Cholecystokinin Octapeptide) Versus Placebo in Neonates at High Risk for Developing Parenteral Nutrition Associated Cholestasis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 252 (planned)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 30 Days
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Cholestasis

Interventions

Type	Name	Description
DRUG	sincalide

Timeline

• Start date: 1997-09-01
• Completion: 2002-06-01
• First posted: 1999-10-19
• Last updated: 2015-03-25

Locations

6 sites across 1 country: United States