Minimization of IntraLipid Versus Omegaven

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

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-12-31

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.

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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).

Conditions

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Cholestasis Parenteral Nutrition Associated Liver Disease (PNALD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lipid minimization

Group Type ACTIVE_COMPARATOR

Lipid minimization

Intervention Type DIETARY_SUPPLEMENT

1g/kg/day daily until infant receiving full enteral feeds

IF conjugated bili rises above 100, crossover to Omegaven (1gram/kg/day)

Omegaven

Group Type EXPERIMENTAL

Omegaven

Intervention Type DIETARY_SUPPLEMENT

Omegaven 1g/kg/day until infant receiving full enteral feeds

Interventions

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Omegaven

Omegaven 1g/kg/day until infant receiving full enteral feeds

Intervention Type DIETARY_SUPPLEMENT

Lipid minimization

1g/kg/day daily until infant receiving full enteral feeds

IF conjugated bili rises above 100, crossover to Omegaven (1gram/kg/day)

Intervention Type DIETARY_SUPPLEMENT

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

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No