Who is sponsoring NCT00862446?

NCT00862446 is sponsored by Vanderbilt University Medical Center.

What condition does NCT00862446 study?

NCT00862446 studies Parenteral Nutrition Associated Liver Disease.

What is the status of NCT00862446?

NCT00862446 is currently COMPLETED.

Last reviewed 2020-12-11 · How we verify

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

NCT00862446 Phase 4 COMPLETED Results posted

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.

Details

Lead sponsor	Vanderbilt University Medical Center
Phase	Phase 4
Status	COMPLETED
Enrolment	48
Start date	2009-03
Completion	2019-10

Conditions

Parenteral Nutrition Associated Liver Disease

Interventions

Omegaven

Primary outcomes

Number of Participants With Resolution of the Direct Hyperbilirubinemia — At discharge or up to 10 weeks
Defined as direct bilirubin \<2.0 mg/dL

Countries

United States