NCT01247012

Minimization of IntraLipid Versus Omegaven

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Children's & Women's Health Centre of British Columbia · Academic / Other
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

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).

Conditions

• Cholestasis
• Parenteral Nutrition Associated Liver Disease (PNALD)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Omegaven	Omegaven 1g/kg/day until infant receiving full enteral feeds
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)

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2010-11-24
• Last updated: 2011-09-07

Locations

1 site across 1 country: Canada