Minimization of IntraLipid Versus Omegaven (MILOve)

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

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.

Study Overview

• Status: Unknown
• Conditions: Cholestasis; Parenteral Nutrition Associated Liver Disease (PNALD)
• Intervention / Treatment: Dietary supplement: Lipid minimization; Dietary supplement: Omegaven

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • Recruiting
      • Children's & Women's Health Centre of BC
      • Contact: Jennifer Claydon; Email: jclaydon@cw.bc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lipid minimization	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)
Experimental: Omegaven	Dietary supplement: Omegaven; Omegaven 1g/kg/day until infant receiving full enteral feeds

What is the study measuring?

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	Time Frame
Total duration of parenteral nutrition	up to 1 year
Growth	up to 1 year

Collaborators and Investigators

• Sponsor: Children's & Women's Health Centre of British Columbia
• Collaborators: Child and Family Research Institute
• Investigators: Principal Investigator: Susan Albersheim, MD, PhD, Children's & Women's Health Centre of BC; Principal Investigator: Avash J Singh, MD, Children's & Women's Health Centre of BC; Principal Investigator: Rebecca Sherlock, MD, Children's & Women's Health Centre of BC

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: November 23, 2010
• First Submitted That Met QC Criteria: November 23, 2010
• First Posted (Estimate): November 24, 2010

Study Record Updates

• Last Update Posted (Estimate): September 7, 2011
• Last Update Submitted That Met QC Criteria: September 6, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Liver Diseases; Cholestasis
• Other Study ID Numbers: MILOVE-134698