Minimization of IntraLipid Versus Omegaven (MILOve)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Children's & Women's Health Centre of British Columbia.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Child and Family Research Institute
Information provided by:
Children's & Women's Health Centre of British Columbia
ClinicalTrials.gov Identifier:
NCT01247012
First received: November 23, 2010
Last updated: September 6, 2011
Last verified: September 2011
  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
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    "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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Growth [ Time Frame: up to 1 year ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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

Additional relevant MeSH terms:
Cholestasis
Liver Diseases
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014