Minimization of IntraLipid Versus Omegaven

NCT01247012 — Phase 2 / Phase 3, Unknown, 40 participants, Children's & Women's Health Centre of British Columbia

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

A Randomized Controlled Trial of Minimization of Intralipid Versus Omegaven for the Treatment of Severe Cholestasis- A Pilot Trial

Registry	NCT01247012, acronym MILOve
Status	Unknown
Phase	Phase 2 / Phase 3
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	40 (Estimated)
Sponsor	Children's & Women's Health Centre of British Columbia (Other); collaborators: Child and Family Research Institute
Conditions	Cholestasis, Parenteral Nutrition Associated Liver Disease (PNALD)
Interventions	Omegaven, Lipid minimization (Dietary supplement)
Dates	start 2010-12-01, primary completion 2012-12-01 (estimated), completion 2012-12-01 (estimated), first posted 2010-11-24, last updated 2011-09-07
Locations	1 site in Canada

-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.

Expand all sections · Collapse all

+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).

+Arms and interventions

Arm	Type	Interventions	Description
Lipid minimization	Active comparator	Dietary Supplement: Lipid minimization
Omegaven	Experimental	Dietary Supplement: Omegaven

Omegaven (Dietary supplement): Omegaven 1g/kg/day until infant receiving full enteral feeds
Lipid minimization (Dietary supplement): 1g/kg/day daily until infant receiving full enteral feeds IF conjugated bili rises above 100, crossover to Omegaven (1gram/kg/day)

+Outcome measures

Primary outcomes

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 outcomes

Total duration of parenteral nutrition [up to 1 year]
Growth [up to 1 year]

+Eligibility

Sex: All, ages: any to 6 Months

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

+Locations (1)

Facility	City	Country	Status
Children's & Women's Health Centre of BC	Vancouver, British Columbia	Canada	Recruiting

+Investigators

Susan Albersheim, MD, PhD, Principal investigator, Children's & Women's Health Centre of BC
Avash J Singh, MD, Principal investigator, Children's & Women's Health Centre of BC
Rebecca Sherlock, MD, Principal investigator, Children's & Women's Health Centre of BC