CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 48 enrolled
Drug / intervention
Omegavendrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00862446
NCT00862446Phase 4Completed
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Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease

Vanderbilt University Medical Center·interventional·Posted Mar 17, 2009·Updated Jan 5, 2021

In Brief

A Phase 4 clinical trial evaluating Omegaven for Parenteral Nutrition Associated Liver Disease. Completed, enrolled 48 participants across 1 site.

Detailed Summary

Babies in the newborn intensive care unit who are dependent upon intravenous nutrition for a long period of time frequently develop liver damage. The fat used is called intralipid and is made from soybean oil. There is a suggestion in the literature that using fish oil based fats called omega-3 fat emulsions can decrease or even reverse this liver damage. We will offer babies with evidence of liver damage and no ability to eat,the Omegaven and see if the liver damage reverses.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParenteral Nutrition Associated Liver Disease
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 17, 2009
Enrollment StartMar 1, 2009
Primary CompletionOct 1, 2019
TodayJul 2, 2026
Enrollment to primary: 10.6 yearsPosted 17.3 years ago

Interventions

Omegavendrug

1 gram/kg/day daily until on feeds