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

Parenteral Nutrition Associated Liver Disease Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Liver Diseases
• Parenteral Nutrition Associated Liver Disease

• NCT number: NCT00862446
• Study type: Interventional
• Source: Vanderbilt University Medical Center
• Status: Completed
• Phase: Phase 4
• Start date: March 2009
• Completion date: October 2019