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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 is a Phase 3 study that has completed, run by University of Michigan. The registered enrollment target is 22 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02357576
The ClinicalTrials.gov registry entry for NCT02357576 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Intralipid 20% I.V. Fat Emulsion is the first listed.
NCT02357576 reports 0 study locations.
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.
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