Recruiting
Phase 2
Phase 3

IntraLipid vs. Omegaven

Sponsor:

Children's & Women's Health Centre of British Columbia

Code:

NCT01247012

Conditions

Cholestasis

Parenteral Nutrition Associated Liver Disease (PNALD)

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Omegaven

Lipid minimization

Study Details

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.

Conditions

Cholestasis

Parenteral Nutrition Associated Liver Disease (PNALD)

Study ID

NCT01247012

Start date

Dec, 2010

Status verified date

Sep, 2011

Completion date

Dec, 2012

Anticipated

Primary completion date

Dec, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Lipid minimization

experimental: Omegaven

Interventions

Omegaven

Omegaven 1g/kg/day until infant receiving full enteral feeds

Lipid minimization

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

  • Feasibility [ Time Frame: up to 1 year ]
  • Clinical endpoint [ Time Frame: up to 1 year ]

Central Contacts and Locations

Locations

Children's & Women's Health Centre of BC

Recruiting

Vancouver, British Columbia, Canada

Contacts

Jennifer Claydon

jclaydon@cw.bc.ca

More Information

Sponsor

Children's & Women's Health Centre of British Columbia

Last update posted

Sep 7, 2011

Last verified

Sep, 2011

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's & Women's Health Centre of British Columbia on 2011-09-07.