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Omegaven® as Parenteral Nutrition

NCT02334293 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2015-01-08

No results posted yet for this study

Summary

The purpose of this study is to determine if a fat emulsion comprised of omega-3 fatty acids, Omegaven, would be beneficial in the management of steatotic liver injury in parenteral nutrition (PN) by its inhibition of de novo lipogenesis, the reduction of arachidonic acid-derived inflammatory mediators, prevention of essential fatty acid deficiency through the presence of small amounts of arachidonic acid, and improved clearance of lipids from the serum.

Conditions

  • Cholestasis

Interventions

DRUG

Omegaven

Omegaven® fat emulsion will be used as a Compassionate Use treatment for critically ill infants with PN associated liver injury.

Sponsors & Collaborators

  • Carle Foundation Hospital

    lead OTHER

Principal Investigators

  • William Stratton, MD · Carle Foundation Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Days
Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2017-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02334293 on ClinicalTrials.gov