Minimization of IntraLipid Versus Omegaven (MILOve)

Children's & Women's Health Centre of British Columbia

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Cholestasis; Parenteral Nutrition Associated Liver Disease (PNALD)

Treatments: Dietary Supplement: Lipid minimization; Dietary Supplement: Omegaven

Study type: Interventional

Funder types: Other

Identifiers

NCT01247012

MILOVE-134698

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 estimated patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Lipid minimization

Active Comparator group

Treatment:

Dietary Supplement: Lipid minimization

Omegaven

Experimental group

Treatment:

Dietary Supplement: Omegaven