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
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2010
CompletedFirst Posted
Study publicly available on registry
November 24, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedSeptember 7, 2011
September 1, 2011
2 years
November 23, 2010
September 6, 2011
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Total duration of parenteral nutrition
up to 1 year
Growth
up to 1 year
Study Arms (2)
Lipid minimization
ACTIVE COMPARATOROmegaven
EXPERIMENTALInterventions
1g/kg/day daily until infant receiving full enteral feeds IF conjugated bili rises above 100, crossover to Omegaven (1gram/kg/day)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's & Women's Health Centre of BC
Vancouver, British Columbia, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 23, 2010
First Posted
November 24, 2010
Study Start
December 1, 2010
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
September 7, 2011
Record last verified: 2011-09