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Minimization of IntraLipid Versus Omegaven (MILOve)

Primary Purpose

Cholestasis, Parenteral Nutrition Associated Liver Disease (PNALD)

Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Omegaven
Lipid minimization
Sponsored by
Children's & Women's Health Centre of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholestasis

Eligibility Criteria

undefined - 6 Months (Child)All SexesDoes not accept 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

Sites / Locations

  • Children's & Women's Health Centre of BCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Lipid minimization

Omegaven

Arm Description

Outcomes

Primary Outcome Measures

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.
Clinical endpoint
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
Growth

Full Information

First Posted
November 23, 2010
Last Updated
September 6, 2011
Sponsor
Children's & Women's Health Centre of British Columbia
Collaborators
Child and Family Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01247012
Brief Title
Minimization of IntraLipid Versus Omegaven
Acronym
MILOve
Official Title
A Randomized Controlled Trial of Minimization of Intralipid Versus Omegaven for the Treatment of Severe Cholestasis- A Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Children's & Women's Health Centre of British Columbia
Collaborators
Child and Family Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholestasis, Parenteral Nutrition Associated Liver Disease (PNALD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lipid minimization
Arm Type
Active Comparator
Arm Title
Omegaven
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Omegaven
Intervention Description
Omegaven 1g/kg/day until infant receiving full enteral feeds
Intervention Type
Dietary Supplement
Intervention Name(s)
Lipid minimization
Intervention Description
1g/kg/day daily until infant receiving full enteral feeds IF conjugated bili rises above 100, crossover to Omegaven (1gram/kg/day)
Primary Outcome Measure Information:
Title
Feasibility
Description
"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.
Time Frame
up to 1 year
Title
Clinical endpoint
Description
The proportion of subjects in each group that have a rise in conjugated bilirubin to or over 100 after randomization
Time Frame
up to 1 year
Secondary Outcome Measure Information:
Title
Total duration of parenteral nutrition
Time Frame
up to 1 year
Title
Growth
Time Frame
up to 1 year

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Albersheim, MD, PhD
Organizational Affiliation
Children's & Women's Health Centre of BC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Avash J Singh, MD
Organizational Affiliation
Children's & Women's Health Centre of BC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rebecca Sherlock, MD
Organizational Affiliation
Children's & Women's Health Centre of BC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's & Women's Health Centre of BC
City
Vancouver
State/Province
British Columbia
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Claydon
Email
jclaydon@cw.bc.ca

12. IPD Sharing Statement

Learn more about this trial

Minimization of IntraLipid Versus Omegaven

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