NCT00862446

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 24 Months
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Parenteral Nutrition Associated Liver Disease

Interventions

Type	Name	Description
DRUG	Omegaven	1 gram/kg/day daily until on feeds

Timeline

• Start date: 2009-03-01
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2009-03-17
• Last updated: 2021-01-05
• Results posted: 2020-12-14

Locations

1 site across 1 country: United States