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Trial record 24 of 31 for:    "Gastroschisis"

Compassionate Use of Omegaven in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02370251
Recruitment Status : Active, not recruiting
First Posted : February 24, 2015
Last Update Posted : March 1, 2019
OU Medical Center
Information provided by (Responsible Party):
University of Oklahoma

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.

Condition or disease Intervention/treatment Phase
Total Parenteral Nutrition-induced Cholestasis Cholestasis Short Bowel Syndrome Gastroschisis Intestinal Atresia Infant, Premature, Diseases Cholestasis of Parenteral Nutrition Drug: Omegaven Phase 2 Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fish Oil Lipid Emulsion for the Treatment of Parenteral-Nutrition-Associated Liver Disease in Infants
Actual Study Start Date : June 2015
Actual Primary Completion Date : September 27, 2018
Estimated Study Completion Date : September 26, 2019

Arm Intervention/treatment
Experimental: Omegaven
Children will receive Omegaven at a maximum of 1 g/kg/day upon enrollment in this arm.
Drug: Omegaven
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 Outcome Measures :
  1. Resolution of cholestasis [ 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 Outcome Measures :
  1. 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

  2. Essential fatty acid deficiency [ Time Frame: Within the first month of use ]
    To determine if Omegaven can resolve essential fatty acid deficiency

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02370251

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United States, Oklahoma
OU Children's Hospital
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
OU Medical Center
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Principal Investigator: Kimberly D Ernst, MD, MSMI The University of Oklahoma, Department of Pediatrics

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Responsible Party: University of Oklahoma Identifier: NCT02370251     History of Changes
Other Study ID Numbers: 5451
First Posted: February 24, 2015    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019

Keywords provided by University of Oklahoma:
Fat Emulsions, Intravenous
Parenteral-Nutrition-Associated Liver Disease
Fish Oil

Additional relevant MeSH terms:
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Short Bowel Syndrome
Infant, Premature, Diseases
Intestinal Atresia
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Postoperative Complications
Pathologic Processes
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities
Hernia, Abdominal
Pathological Conditions, Anatomical
Infant, Newborn, Diseases
Digestive System Abnormalities