Minimization of IntraLipid Versus Omegaven

Study Overview
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Brief Summary
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Prolonged use of parenteral nutrition can lead to parenteral nutrition associated liver disease (PNALD). The purpose of this study is to determine the effect of treatment with a smaller amount lipid minimization) of our standard soybean oil based intravenous lipid emulsion (Intralipid) versus a fish-oil based lipid emulsion (Omegaven) in infants with severe cholestasis.

Detailed Description
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Infants meeting eligibility will be randomized to receive either 1g/kg/day of Intralipid® 20% or 1g/kg/day Omegaven® 10%. Infants randomized to Intralipid® whose conjugated bilirubin level rises >100umol/L will be crossed over to receive 1g/kg/day Omegaven®. Monitoring includes liver function tests (AST, ALT,ALP, GGT, Conjugated Bilirubin), Fatty Acid Profile (RBC and serum fatty acids; triene/tetraene ratio), INR (coagulation profile) and cytokine measure (inflammatory markers).

Official Title
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A Randomized Controlled Trial of Minimization of Intralipid Versus Omegaven for the Treatment of Severe Cholestasis- A Pilot Trial

Conditions
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Cholestasis, Parenteral Nutrition Associated Liver Disease (PNALD)

Intervention / Treatment
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* Dietary Supplement: Omegaven
* Dietary Supplement: Lipid minimization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: infants admitted to neonatal intensive care unit severe cholestasis, defined as conjugated bilirubin greater than 35 receiving at least 60% calories by IV infusion and expected to require intravenous nutrition for at least an additional 28 days signed consent Exclusion Criteria: hepatitis (TORCH or other viral infection) primary liver disease as etiology of cholestasis clinically severe bleeding not able to be managed with routine measures lethal congenital abnormalities congenital heart disease associated with right heart dysfunction

Ages Eligible for Study
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Maximum Age: 6 Months

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lipid minimization<br> | Dietary Supplement: Lipid minimization<br>* 1g/kg/day daily until infant receiving full enteral feeds IF conjugated bili rises above 100, crossover to Omegaven (1gram/kg/day)<br>|
| Experimental: Omegaven<br> | Dietary Supplement: Omegaven<br>* Omegaven 1g/kg/day until infant receiving full enteral feeds<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility | Success of the pilot trial will be determined by reaching the following criteria: 98.5% of subjects receive the modified lipid therapy within 12 to 24h of randomization; and/or 90% of subjects had their labs taken at the appropriate times as detailed by the study protocol. | up to 1 year | 
| Clinical endpoint | The proportion of subjects in each group that have a rise in conjugated bilirubin to or over 100 after randomization | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total duration of parenteral nutrition |  | up to 1 year | 
| Growth |  | up to 1 year |