Use of Omegaven Fish Oil Emulsion for Parenteral Nutrition Associated Liver Disease in Infants and Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-20

Study Completion Date

2019-01-15

Brief Summary

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Use of a fish oil emulsion to decrease liver disease due to long term intravenous nutrition.

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Detailed Description

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Unlike conventional intravenous fat emulsions, Omegaven™ is comprised solely of fish oils containing primarily omega-3 fatty acids. Animal studies have shown that IV fat emulsions such as fish oil that are high in eicosapentaenic and docosahexaenoic acids reduce impairment of bile flow as seen in cholestasis caused by conventional fat emulsions. It is thought that by administering Omegaven™ in place of conventional phytosterol/soybean fat emulsions, cholestasis may be prevented or reversed, and patients will be able to be maintained on adequate PN for growth until they are able to ingest adequate nutrition enterally. Ongoing studies are addressing safety and efficacy of Omegaven™ in the pediatric population. In this trial, infants and children with parenteral nutrition associated liver disease will receive Omegaven™ as compassionate use to potentially prevent progression of disease. Safety and efficacy are monitored.

Conditions

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Cholestasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Omegaven

Administration of intravenous Omega-3 fish oil lipid emulsion 1 g/kg continuous infusion over 12-24 hrs

Group Type EXPERIMENTAL

Omega-3 fish oil lipid emulsion

Intervention Type DRUG

daily intravenous administration of Omegaven fish oil emulsion

Interventions

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Omega-3 fish oil lipid emulsion

daily intravenous administration of Omegaven fish oil emulsion

Intervention Type DRUG

Other Intervention Names

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Omegaven

Eligibility Criteria

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Inclusion Criteria

* direct bilirubin \> 2 mg/dl x2 consecutive
* parenteral nutrition dependent, expected to continue for at least another 30 days from the first day
* patient must have utilized standard therapies to prevent the progression of liver disease

Exclusion Criteria

* other primary cause of liver disease not parenteral nutrition-associated
* weight \<3 kg
* infant or child enrolled in other clinical trial involving an investigational agent

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No