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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01247012
First Posted: November 24, 2010
Last Update Posted: September 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Child and Family Research Institute
Information provided by:
Children's & Women's Health Centre of British Columbia
  Purpose
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
Cholestasis 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: None (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).
  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01247012


Locations
Canada, British Columbia
Children's & Women's Health Centre of BC Recruiting
Vancouver, British Columbia, Canada
Contact: Jennifer Claydon       jclaydon@cw.bc.ca   
Sponsors and Collaborators
Children's & Women's Health Centre of British Columbia
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
  More Information

Responsible Party: Children's & Women's Health Centre of British Columbia
ClinicalTrials.gov Identifier: NCT01247012     History of Changes
Other Study ID Numbers: MILOVE-134698
First Submitted: November 23, 2010
First Posted: November 24, 2010
Last Update Posted: September 7, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Liver Diseases
Cholestasis
Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases
Soybean oil, phospholipid emulsion
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions