Clinical Trial: Compassionate Use of Omegaven in Children
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Fish Oil Lipid Emulsion for the Treatment of Parenteral-Nutrition-Associated Liver Disease in Infants
Brief Summary: 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.
Detailed 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.
Sponsor: University of Oklahoma
Current Primary Outcome: Resolution of cholestasis [ Time Frame: Within the first 3 months of sole Omegaven use ]
Original Primary Outcome:
- Peak direct bilirubin levels [ Time Frame: Within the first year of life ]Comparison of the highest direct bilirubin level for those receiving prophylactic Omegaven vs Intralipid
- Resolution of cholestasis [ Time Frame: Within the first year of life ]Comparison of treatment with Omegaven vs Intralipid for the length of time for cholestasis to resolve (DB <2 for 2 consecutive weeks)
- Dose-effect on peak bilirubin, rate of rise, and rate of resolution [ Time Frame: Within the first year of life ]Comparison of 1 g/kg/day vs 1.5 g/kg/day of Omegaven and Intralipid on peak direct bilirubin levels, rate of rise, and/or rate of cholestasis resolution
Current Secondary Outcome:
- Safety issues [ Time Frame: Within the first year of use ]To determine if Omegaven results in safety issues such as increased bleeding, essential fatty acid deficiency, elevated triglyceride levels, elevated liver function tests, increased liver and/or intestinal transplant rates, or death
- Essential fatty acid deficiency [ Time Frame: Within the first three months of combined use ]To determine if the combination of Omegaven and Intralipid results in normalized lipid profiles.
Original Secondary Outcome:
- Neurodevelopmental outcomes [ Time Frame: The first 2 years of life ]Comparison of monotherapy on Bayley III scores (total, cognitive, language, and motor scaled scores) at 18 +/- 6 months for those on monotherapy
- Retinopathy of prematurity [ Time Frame: The first 6 months of life ]Comparison of monotherapy on the incidence and severity of retinopathy
- Sepsis [ Time Frame: The first year of life ]Comparison of the rate of blood, line, or urosepsis while on parenteral nutrition
- Growth and fat mass accretion [ Time Frame: The first 2 years of life ]Comparison of weight, length, and head circumference growth from birth to neurodevelopmental follow-up as well as fat mass accretion as measured by air displacement plethysmography
- Steatosis (fatty liver) [ Time Frame: The first year of life ]Comparison of the incidence and severity of steatosis
- Liver transplant and/or death [ Time Frame: The first 2 years of life ]Comparison of the rate of liver transplant and/or death
- Endothelial injury markers [ Time Frame: The first six months of life ]Endothelial injury markers in relation to the direct bilirubin levels
Information By: University of Oklahoma
Dates:
Date Received: February 17, 2015
Date Started: June 2015
Date Completion: April 2021
Last Updated: November 18, 2016
Last Verified: November 2016