Back to resultsUse of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease
Primary Purpose
Parenteral Nutrition Associated Liver Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Omegaven
Sponsored by
About this trial
This is an interventional treatment trial for Parenteral Nutrition Associated Liver Disease focused on measuring Parenteral nutrition associate liver disease, TPN cholestasis, TPN Associated Liver Disease
Eligibility Criteria
Inclusion Criteria:
- Infants in the newborn intensive care unit
- TPN cholestasis of at least 2.5 mg/dl
- Anticipated TPN treatment for at least one month
- signed informed consent
Exclusion Criteria:
- Enrollment in another trial
- Lack of consent
Sites / Locations
- Monroe Carell Jr Children's Hospital at vanderbilt
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
All infants will receive Omegaven
Outcomes
Primary Outcome Measures
Number of Participants With Resolution of the Direct Hyperbilirubinemia
Defined as direct bilirubin <2.0 mg/dL
Secondary Outcome Measures
Full Information
NCT ID
NCT00862446
First Posted
March 13, 2009
Last Updated
December 11, 2020
Sponsor
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00862446
Brief Title
Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease
Official Title
Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
March 2009 (Actual)
Primary Completion Date
October 2019 (Actual)
Study Completion Date
October 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanderbilt University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Babies in the newborn intensive care unit who are dependent upon intravenous nutrition for a long period of time frequently develop liver damage. The fat used is called intralipid and is made from soybean oil. There is a suggestion in the literature that using fish oil based fats called omega-3 fat emulsions can decrease or even reverse this liver damage. We will offer babies with evidence of liver damage and no ability to eat,the Omegaven and see if the liver damage reverses.
Detailed Description
Babies in the newborn intensive care unit with evidence of liver damage from Total Parenteral Nutrition (TPN), as indicated by a direct bilirubin of greater than 2.5 , and who will not be fed for at least another month will be offered the trial. they will be changed from the intralipid to Omegaven as the source of their fat. We will continue routine monitoring of their nutrition and liver function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parenteral Nutrition Associated Liver Disease
Keywords
Parenteral nutrition associate liver disease, TPN cholestasis, TPN Associated Liver Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
All infants will receive Omegaven
Intervention Type
Drug
Intervention Name(s)
Omegaven
Intervention Description
1 gram/kg/day daily until on feeds
Primary Outcome Measure Information:
Title
Number of Participants With Resolution of the Direct Hyperbilirubinemia
Description
Defined as direct bilirubin <2.0 mg/dL
Time Frame
At discharge or up to 10 weeks
10. Eligibility
Sex
All
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Infants in the newborn intensive care unit
TPN cholestasis of at least 2.5 mg/dl
Anticipated TPN treatment for at least one month
signed informed consent
Exclusion Criteria:
Enrollment in another trial
Lack of consent
Facility Information:
Facility Name
Monroe Carell Jr Children's Hospital at vanderbilt
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease
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