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

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

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.

Official Title
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Use of Omegaven for Parenteral Nutrition Associated Liver Disease

Conditions
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Cholestasis

Intervention / Treatment
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* Drug: Omega-3 fish oil lipid emulsion


Participation Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omegaven<br>Administration of intravenous Omega-3 fish oil lipid emulsion 1 g/kg continuous infusion over 12-24 hrs | Drug: Omega-3 fish oil lipid emulsion<br>* daily intravenous administration of Omegaven fish oil emulsion<br>* Other names: Omegaven;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improving cholestasis | decline in serum direct bilirubin levels below 2 cm on 2 serial measures | One month, 2 months, 3 months after starting omegaven and 1 month after completing treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improving liver function tests | includes ALT, AST, GGT, and triglycerides | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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short bowel syndrome, parenteral nutrition associated liver disease, pediatric