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

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.

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Key information

Conditions

Parenteral Nutrition Associated Liver Disease

Age range

Up to 24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Monroe Carell Jr Children's Hospital at vanderbilt

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omegaven

Drug

1 gram/kg/day daily until on feeds

Primary outcomes

Number of Participants With Resolution of the Direct Hyperbilirubinemia

Time frame: At discharge or up to 10 weeks

Defined as direct bilirubin <2.0 mg/dL

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2019
Study completion: 2019
First posted: Mar 17, 2009
Registry last updated: Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed