Compassionate Use of Omegaven in Children

University of Oklahoma63 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Total Parenteral Nutrition-induced Cholestasis Cholestasis Short Bowel Syndrome Gastroschisis Intestinal Atresia Infant, Premature, Diseases Cholestasis of Parenteral Nutrition

Interventions

OmegavenDRUG

Once the direct bilirubin is 2 mg/dL or more x 2 weeks, Intralipid will be switched to Omegaven at 1 g/kg/day. The bilirubin level will be monitored to determine when resolution of cholestasis (DB \<2 mg/dL) occurs.

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

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 1.7 g/kg/day (24 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

Locations (1)

OU Children's Hospital

Oklahoma City, Oklahoma, United States

Outcomes

Primary Outcomes

Resolution of Cholestasis for Subjects Who Received Omegaven

To determine if Omegaven results in the resolution of cholestasis (DB \<2 for 2 consecutive weeks)

Time frame: Within the first 3 months of sole Omegaven use

Secondary Outcomes

Safety Issues for Infants Who Received Omegaven

To determine if Omegaven results in safety issues such as increased bleeding, essential fatty acid deficiency, elevated liver function tests, increased liver and/or intestinal transplant rates, or death

Time frame: Within the first year of use

Essential Fatty Acid Deficiency in Infants Who Received Omegaven

To determine if Omegaven can resolve essential fatty acid deficiency

Time frame: Within the first month of use

Data from ClinicalTrials.gov

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