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Compassionate Use of Omegaven in Children

Primary Purpose

Total Parenteral Nutrition-induced Cholestasis, Cholestasis, Short Bowel Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Omegaven
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Total Parenteral Nutrition-induced Cholestasis focused on measuring Fat Emulsions, Intravenous, Parenteral-Nutrition-Associated Liver Disease, Cholestasis, Omegaven, Fish Oil

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • OU Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Omegaven

Arm Description

Children will receive Omegaven at a maximum of 1 g/kg/day upon enrollment in this arm.

Outcomes

Primary Outcome Measures

Resolution of Cholestasis for Subjects Who Received Omegaven
To determine if Omegaven results in the resolution of cholestasis (DB <2 for 2 consecutive weeks)

Secondary Outcome Measures

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
Essential Fatty Acid Deficiency in Infants Who Received Omegaven
To determine if Omegaven can resolve essential fatty acid deficiency

Full Information

First Posted
February 17, 2015
Last Updated
November 19, 2019
Sponsor
University of Oklahoma
Collaborators
OU Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02370251
Brief Title
Compassionate Use of Omegaven in Children
Official Title
Fish Oil Lipid Emulsion for the Treatment of Parenteral-Nutrition-Associated Liver Disease in Infants
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
September 27, 2018 (Actual)
Study Completion Date
September 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
Collaborators
OU Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Parenteral Nutrition-induced Cholestasis, Cholestasis, Short Bowel Syndrome, Gastroschisis, Intestinal Atresia, Infant, Premature, Diseases, Cholestasis of Parenteral Nutrition
Keywords
Fat Emulsions, Intravenous, Parenteral-Nutrition-Associated Liver Disease, Cholestasis, Omegaven, Fish Oil

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omegaven
Arm Type
Experimental
Arm Description
Children will receive Omegaven at a maximum of 1 g/kg/day upon enrollment in this arm.
Intervention Type
Drug
Intervention Name(s)
Omegaven
Other Intervention Name(s)
Fish oil-based lipid, Omega-3-fatty acid lipid emulsion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Resolution of Cholestasis for Subjects Who Received Omegaven
Description
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 Outcome Measure Information:
Title
Safety Issues for Infants Who Received Omegaven
Description
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
Title
Essential Fatty Acid Deficiency in Infants Who Received Omegaven
Description
To determine if Omegaven can resolve essential fatty acid deficiency
Time Frame
Within the first month of use

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 1.7 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly D Ernst, MD, MSMI
Organizational Affiliation
The University of Oklahoma, Department of Pediatrics
Official's Role
Principal Investigator
Facility Information:
Facility Name
OU Children's Hospital
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

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Compassionate Use of Omegaven in Children

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