Minimization of IntraLipid Versus Omegaven

Phase 2

• Conditions: Cholestasis; Parenteral Nutrition Associated Liver Disease (PNALD)
• Interventions: Dietary Supplement: Lipid minimization; Dietary Supplement: Omegaven

• Registration Number: NCT01247012
• Lead Sponsor: Children's & Women's Health Centre of British Columbia

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2010-11-23
• Study First Submitted QC: 2010-11-23
• Study First Posted: 2010-11-24
• Study Start: 2010-12
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-06
• Last Update Posted: 2011-09-07
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lipid minimization	Lipid minimization	-
Omegaven	Omegaven	-

Primary Outcome Measures

Name	Time	Method
Feasibility	up to 1 year	"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.
Clinical endpoint	up to 1 year	The proportion of subjects in each group that have a rise in conjugated bilirubin to or over 100 after randomization

Secondary Outcome Measures

Name	Time	Method
Total duration of parenteral nutrition	up to 1 year
Growth	up to 1 year

Trial Locations

Locations (1)

Children's & Women's Health Centre of BC; 🇨🇦 Vancouver, British Columbia, Canada