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Completed

NCT Number: NCT02370251

Compassionate Use of Omegaven in Children

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.

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Key information

Conditions

Total Parenteral Nutrition-induced Cholestasis Bile Duct Diseases Biliary Tract Diseases Cholestasis Cholestasis of Parenteral Nutrition Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases Gastrointestinal Diseases Gastroschisis Hernia Hernia, Abdominal Infant, Newborn, Diseases Infant, Premature, Diseases Intestinal Atresia Intestinal Diseases Malabsorption Syndromes Musculoskeletal Abnormalities Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Short Bowel Syndrome

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

OU Children's Hospital

Oklahoma City, Oklahoma, 73104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omegaven

Drug

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.

Other names: Fish oil-based lipid, Omega-3-fatty acid lipid emulsion

Primary outcomes

  1. Resolution of Cholestasis for Subjects Who Received Omegaven

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

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

Secondary outcomes

  1. Safety Issues for Infants Who Received Omegaven

    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 liver function tests, increased liver and/or intestinal transplant rates, or death

  2. Essential Fatty Acid Deficiency in Infants Who Received Omegaven

    Time frame: Within the first month of use

    To determine if Omegaven can resolve essential fatty acid deficiency

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • OU Medical Center

Registry information

Official study title

Fish Oil Lipid Emulsion for the Treatment of Parenteral-Nutrition-Associated Liver Disease in Infants

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Feb 24, 2015
Registry last updated
Nov 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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