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NCT00004414 · ClinicalTrials.gov registry record · NA
Sincalide (Cholecystokinin Octapeptide) Versus Placebo in Neonates at High Risk for Developing Parenteral Nutrition Associated Cholestasis
A NA study of Cholestasis, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 252
- Enrollment target
- 6
- Study locations
NCT00004414: Completed NA study of Cholestasis, sponsored by University of Michigan.
NCT00004414 is a NA study of Cholestasis that has completed, run by University of Michigan. The registered enrollment target is 252 participants, above the 116-participant average among 6 other Cholestasis trials with a reported enrollment target (117% higher). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00004414, a NA study of Cholestasis, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 252 participants
- Enrollment target
- 6
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG sincalide
Study Locations (6)
Maryland
- Johns Hopkins Oncology Center - Baltimore
Michigan
- University of Michigan Medical School - Ann Arbor
New York
- University of Rochester Medical Center - Rochester
Ohio
- Children's Hospital Medical Center - Cincinnati - Cincinnati
Rhode Island
- Rhode Island Hospital - Providence
Texas
- Baylor University Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 252 participants |
| Start Date | 1997-09 |
| Est. Completion | 2002-06 |
| Phase | NA |
What the finished NCT00004414 record still lists
NCT00004414 is an interventional study that assigns participants to a tested intervention. The registered 252 participants enrollment target is mid-sized for trials with a published cap, above the 116-participant average among 6 other Cholestasis trials with a reported enrollment target (117% higher).
The record links to 1 condition, with Cholestasis appearing as the primary indexed condition, and to 1 intervention - of which sincalide is the first listed.
NCT00004414 lists 6 locations in 6 states (Maryland, Michigan, New York).
Frequently Asked Questions
What is clinical trial NCT00004414 about?
NCT00004414 is a clinical study titled "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 he...
What is the current status of trial NCT00004414?
This trial is currently completed. It is a NA study. The enrollment target is 252 participants. The study started on 1997-09. Estimated completion is 2002-06.
What conditions does trial NCT00004414 study?
This clinical trial studies the following conditions: Cholestasis.
What interventions are being tested in trial NCT00004414?
The interventions under investigation include: sincalide (DRUG).
Who is sponsoring clinical trial NCT00004414?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00004414 being conducted?
This trial has 6 study locations across Maryland, Michigan, New York, Ohio, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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