Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease
Purpose
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.
Condition
- Parenteral Nutrition Associated Liver Disease
Eligibility
- Eligible Ages
- Under 24 Months
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment |
All infants will receive Omegaven |
|
More Details
- Status
- Completed
- Sponsor
- Vanderbilt University Medical Center
Study Contact
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.