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NCT02357576 · ClinicalTrials.gov registry record · Phase 3
Standard Lipid Therapy vs IVFE Minimization for Prevention of PNALD
A Phase 3 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 3
- Development phase
- 22
- Enrollment target
NCT02357576: Completed Phase 3 study, sponsored by University of Michigan.
NCT02357576 is a Phase 3 study that has completed, run by University of Michigan. The registered enrollment target is 22 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
NCT02357576, a Phase 3 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 22 participants
- Enrollment target
Study Summary
Parenteral nutrition-associated cholestasis (PNAC) and liver disease (PNALD) are associated with significant morbidity and mortality in neonates and is felt to be exacerbated by soybean-based lipid emulsions. Much research is currently being directed at identifying ways to reduce this risk. Reduction of the dose of soybean-based lipid given as a component of parenteral nutrition is one possible strategy. In this study we will compare standard dosing of soybean-based lipid (up to 3/kg/day) with a minimized dose (1 g/kg/day) and evaluate for the development of cholestasis and adequate growth between the two groups. Longterm followup will include an assessment of neurodevelopmental outcomes at 12 and 24 months of age. Funding source - FDA OOPD
Primary Outcome
The rate of rise (change over time) of direct bilirubin was compared between the two groups at different time points.
Interventions
- DRUG Intralipid 20% I.V. Fat Emulsion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2016-05-21 |
| Est. Completion | 2019-11-08 |
| Phase | Phase 3 |
What the finished NCT02357576 record still lists
NCT02357576 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 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 1 intervention - of which Intralipid 20% I.V. Fat Emulsion is the first listed.
NCT02357576 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02357576 about?
NCT02357576 is a clinical study titled "Standard Lipid Therapy vs IVFE Minimization for Prevention of PNALD". Parenteral nutrition-associated cholestasis (PNAC) and liver disease (PNALD) are associated with significant morbidity and mortality in neonates and is felt to be exacerbated by soybean-based lipid emulsions. Much research is currently being directed at identifying ways to reduce this risk. Reductio...
What is the current status of trial NCT02357576?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 22 participants. The study started on 2016-05-21. Estimated completion is 2019-11-08.
What interventions are being tested in trial NCT02357576?
The interventions under investigation include: Intralipid 20% I.V. Fat Emulsion (DRUG).
Who is sponsoring clinical trial NCT02357576?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02357576's enrollment target sits among peer trials
22 1953rd of 2000 higher than 48 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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