Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01373918 · ClinicalTrials.gov registry record · Phase 4
Low Dose Fat for the Prevention of Liver Disease in Babies With Gastrointestinal Disorders
A Phase 4 study, sponsored by University of California, Los Angeles.
- Terminated
- Registry status
- Phase 4
- Development phase
- 41
- Enrollment target
NCT01373918 is a Phase 4 study that was terminated before completion, run by University of California, Los Angeles. The registered enrollment target is 41 participants.
The verdict
NCT01373918, a Phase 4 study, was terminated before completion, sponsored by University of California, Los Angeles.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 41 participants
- Enrollment target
Study Summary
Neonates with congenital/acquired gastrointestinal disorders are at high risk for Parenteral Nutrition Associated Cholestasis (PNAC). Besides enteral nutrition, standard therapies to prevent and treat PNAC have been limited and marginal. Recently, the dose and composition of standard intravenous fat emulsions have implicated in the development and progression of PNAC. In this study, neonates with congenital/acquired gastrointestinal disorders will be randomized, in a unblinded fashion, to receive either the standard dose of an intravenous omega-6 fatty acid emulsion or a low dose of an intravenous omega-6 fatty acid emulsion throughout their course of PN or until hospital discharge, death or 100 days of life, whichever comes first. The primary outcome will be the presence of cholestasis.
Interventions
- DRUG Intralipid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2010-12 |
| Est. Completion | 2014-07 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01373918
The ClinicalTrials.gov registry entry for NCT01373918 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Intralipid is the first listed.
NCT01373918 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01373918 about?
NCT01373918 is a clinical study titled "Low Dose Fat for the Prevention of Liver Disease in Babies With Gastrointestinal Disorders". Neonates with congenital/acquired gastrointestinal disorders are at high risk for Parenteral Nutrition Associated Cholestasis (PNAC). Besides enteral nutrition, standard therapies to prevent and treat PNAC have been limited and marginal. Recently, the dose and composition of standard intravenous fat...
What is the current status of trial NCT01373918?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 41 participants. The study started on 2010-12. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01373918?
The interventions under investigation include: Intralipid (DRUG).
Who is sponsoring clinical trial NCT01373918?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.