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Minimization of IntraLipid Versus Omegaven

NCT01247012 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2011-09-07

No results posted yet for this study

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)

Interventions

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)

Sponsors & Collaborators

  • Child and Family Research Institute

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Susan Albersheim, MD, PhD · Children's & Women's Health Centre of BC

  • Avash J Singh, MD · Children's & Women's Health Centre of BC

  • Rebecca Sherlock, MD · Children's & Women's Health Centre of BC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01247012 on ClinicalTrials.gov