Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/12/2019 |
| Start Date: | March 2009 |
| End Date: | December 2020 |
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 fishoil 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.
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 fishoil 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.
Babies in the newborn intensive care unit with evidence of liver damage from 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.
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.
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
We found this trial at
1
site
Nashville, Tennessee 37232
Principal Investigator: William F Walsh, MD
Phone: 615-322-0545
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