Sincalide (Cholecystokinin Octapeptide) Versus Placebo in Neonates at High Risk for Developing Parenteral Nutrition Associated Cholestasis
- Conditions
- Cholestasis
- Registration Number
- NCT00004414
- Lead Sponsor
- University of Michigan
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 252
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Johns Hopkins Oncology Center
🇺🇸Baltimore, Maryland, United States
University of Michigan Medical School
🇺🇸Ann Arbor, Michigan, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Children's Hospital Medical Center - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Johns Hopkins Oncology Center🇺🇸Baltimore, Maryland, United States