Oklahoma City, Oklahoma 73104


Purpose:

This is a single-assignment study to evaluate whether Omegaven (IV fish oil) is effective at treating liver disease in children on long-term IV nutrition.


Study summary:

Children up to 18 years of age, on parenteral nutrition, with a direct bilirubin level of 2 mg/dL or greater will be eligible to receive Omegaven at a maximum dose of 1 g/kg/day. Up to 200 children will be eligible for enrollment. Direct bilirubin levels and other labs will be monitored as well as growth parameters.


Criteria:

Inclusion Criteria: - Live in or temporarily relocate to Oklahoma - Age less than 18 years, both sexes, all races - Have a direct bilirubin level of ≥2 mg/dL for two consecutive weeks after at least 14 days of parenteral nutrition - Received parenteral lipids at a maximum dose of 1.5 g/kg/day (21 g/kg over the two weeks prior) - Are not currently enrolled in another lipid emulsion study Exclusion Criteria: - Known food allergy to fish - Known metabolic disorder of lipid metabolism - Active coagulopathies (active bleeding or requiring blood product treatment in the prior 48 hours) - Medical condition likely to result in death in the next 30 days


NCT ID:

NCT02370251


Primary Contact:

Principal Investigator
Kimberly D Ernst, MD, MSMI
The University of Oklahoma, Department of Pediatrics

Kimberly D Ernst, MD, MSMI
Phone: 405-271-5215 ext. 42039
Email: omegaven@ouhsc.edu


Backup Contact:

Email: susan.bedwell@hcahealthcare.com
Susan Bedwell, APRN
Phone: 405-271-6169


Location Contact:

Oklahoma City, Oklahoma 73104
United States

Kimberly D Ernst, MD
Phone: 405-271-5266
Email: omegaven@ouhsc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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