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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: Completed Phase 3 study, sponsored by Indiana University.
NCT03387579 is a Phase 3 study that has completed, run by Indiana University. The registered enrollment target is 24 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Cholestasis was defined as a direct bilirubin \> 2 mg/dL on two measurements 5 to 7 days apart.
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 |
What the finished NCT03387579 record still lists
NCT03387579 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Intralipid, 20% Intravenous Emulsion is the first listed.
NCT03387579 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03387579's enrollment target sits among peer trials
24 1943rd of 2000 higher than 49 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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