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Minimization of IntraLipid Versus Omegaven (MILOve)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by Children's & Women's Health Centre of British Columbia.
Recruitment status was:  Recruiting
Child and Family Research Institute
Information provided by:
Children's & Women's Health Centre of British Columbia Identifier:
First received: November 23, 2010
Last updated: September 6, 2011
Last verified: September 2011
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.

Condition Intervention Phase
Parenteral Nutrition Associated Liver Disease (PNALD)
Dietary Supplement: Omegaven
Dietary Supplement: Lipid minimization
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Minimization of Intralipid Versus Omegaven for the Treatment of Severe Cholestasis- A Pilot Trial

Further study details as provided by Children's & Women's Health Centre of British Columbia:

Primary Outcome Measures:
  • Feasibility [ Time Frame: 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 [ Time Frame: 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:
  • Total duration of parenteral nutrition [ Time Frame: up to 1 year ]
  • Growth [ Time Frame: up to 1 year ]

Estimated Enrollment: 40
Study Start Date: December 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01247012

Canada, British Columbia
Children's & Women's Health Centre of BC Recruiting
Vancouver, British Columbia, Canada
Contact: Jennifer Claydon   
Sponsors and Collaborators
Children's & Women's Health Centre of British Columbia
Child and Family Research Institute
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
  More Information

Responsible Party: Children's & Women's Health Centre of British Columbia Identifier: NCT01247012     History of Changes
Other Study ID Numbers: MILOVE-134698
Study First Received: November 23, 2010
Last Updated: September 6, 2011

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases
Soybean oil, phospholipid emulsion
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions processed this record on May 25, 2017