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Sponsors and Collaborators: |
FDA Office of Orphan Products Development University of Michigan |
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Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00004414 |
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.
Condition | Intervention |
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Cholestasis |
Drug: sincalide |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Estimated Enrollment: | 252 |
Study Start Date: | September 1997 |
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.
Ages Eligible for Study: | up to 30 Days |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
United States, Maryland | |
Johns Hopkins Oncology Center | |
Baltimore, Maryland, United States, 21231 | |
United States, Michigan | |
University of Michigan Medical School | |
Ann Arbor, Michigan, United States, 48109-0718 | |
United States, New York | |
University of Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
United States, Ohio | |
Children's Hospital Medical Center - Cincinnati | |
Cincinnati, Ohio, United States, 45229-3039 | |
United States, Rhode Island | |
Rhode Island Hospital | |
Providence, Rhode Island, United States, 02903 | |
United States, Texas | |
Baylor University Medical Center | |
Dallas, Texas, United States, 75246 |
Study Chair: | Daniel Hillel Teitelbaum | University of Michigan |
Study ID Numbers: | 199/13306, UMMS-FDR001449 |
Study First Received: | October 18, 1999 |
Last Updated: | September 6, 2006 |
ClinicalTrials.gov Identifier: | NCT00004414 History of Changes |
Health Authority: | United States: Federal Government |
cholestasis gastrointestinal disorders rare disease |
Digestive System Diseases Cholecystokinin Bile Duct Diseases Cholestasis |
Gastrointestinal Diseases Biliary Tract Diseases Rare Diseases |
Digestive System Diseases Bile Duct Diseases Cholestasis Biliary Tract Diseases |