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NCT03387579 · ClinicalTrials.gov registry record · Phase 3
Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates
A Phase 3 study, sponsored by Indiana University.
- Completed
- Registry status
- Phase 3
- Development phase
- 24
- Enrollment target
NCT03387579 is a Phase 3 study that has completed, run by Indiana University. The registered enrollment target is 24 participants.
The verdict
NCT03387579, a Phase 3 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 24 participants
- Enrollment target
Study Summary
Intestinal failure associated liver disease is a cholestatic liver disease associated with prolonged need for parenteral nutrition that can lead to such significant complications as liver failure. In the neonatal population, infants with history of intestinal resection and short bowel syndrome are at increased risk for this disease. The investigators plan to compare two possible lipid dosing preventative strategies including a composite, fish oil lipid and soy-based lipid reduction.
Interventions
- DRUG Intralipid, 20% Intravenous Emulsion
- DRUG Smoflipid 20% Lipid Emulsion for Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2018-11-30 |
| Est. Completion | 2024-03-19 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03387579
The ClinicalTrials.gov registry entry for NCT03387579 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Intralipid, 20% Intravenous Emulsion is the first listed.
NCT03387579 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03387579 about?
NCT03387579 is a clinical study titled "Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates". Intestinal failure associated liver disease is a cholestatic liver disease associated with prolonged need for parenteral nutrition that can lead to such significant complications as liver failure. In the neonatal population, infants with history of intestinal resection and short bowel syndrome are a...
What is the current status of trial NCT03387579?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 24 participants. The study started on 2018-11-30. Estimated completion is 2024-03-19.
What interventions are being tested in trial NCT03387579?
The interventions under investigation include: Intralipid, 20% Intravenous Emulsion (DRUG), Smoflipid 20% Lipid Emulsion for Injection (DRUG).
Who is sponsoring clinical trial NCT03387579?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
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