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

 --Disease Characteristics-- Severely premature neonates (less than 1000 g at birth and
 estimated gestational age of no greater than 28 weeks) that require greater than 50% of
 caloric requirements by parenteral means within 7 days of birth OR Neonates with one or
 more of the following surgical conditions: Necrotizing enterocolitis Gastroschisis Severe
 jejunal-ileal atresia within 7 days of diagnosis --Prior/Concurrent Therapy-- Biologic
 therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified
 Radiotherapy: Not specified Surgery: See Disease Characteristics No other cardiovascular
 (thoracotomy) or major gastrointestinal surgery (laparotomy) during the newborn period
 Other: No prior or concurrent ursodeoxycholic acid No concurrent use of extracorporeal life
 support --Patient Characteristics-- Performance status: Not specified Hematopoietic: Not
 specified Hepatic: Conjugated bilirubin no greater than 1.0 mg/dL No primary or secondary
 liver disease No hepatic insufficiency as documented by either a biopsy with cirrhosis or
 elevated prothrombin time without evidence of systemic coagulopathy and no administration
 of an anticoagulant Renal: No renal failure as indicated by a progressive increase in
 creatinine levels Other: No hemodynamic instability No documented communicable infection
 (including infectious hepatitis or HIV) No metabolic pathway defect that is associated with
 liver dysfunction in the neonatal period including hereditary fructose intolerance,
 galactosemia due to transferase deficiency, and neonatal tyrosinemia