Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease

Completed · Phase 4

Conditions studied: Parenteral Nutrition Associated Liver Disease

In brief

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.

Key facts

Study ID

NCT00862446

Run by

Vanderbilt University Medical Center

People needed

48

Starts

2009-03-01

Expected to finish

2019-10-01

Last updated by the study team

2021-01-05

Who can join

Age: any, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Enrollment in another trial
• Lack of consent

Where it is running

• Monroe Carell Jr Children's Hospital at vanderbilt — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.