MILOve: Minimization of IntraLipid Versus Omegaven
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- Feasibility [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 [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 [up to 1 year]
- Growth [up to 1 year]
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's & Women's Health Centre of BC | Vancouver | British Columbia | Canada |
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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MILOVE-134698