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

Completed · Not applicable

Conditions studied: Cholestasis

In brief

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.

Key facts

Study ID

NCT00004414

Run by

University of Michigan

People needed

252

Starts

1997-09-01

Expected to finish

2002-06-01

Last updated by the study team

2015-03-25

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.