Evaluation of Omegaven™ Parenteral Nutrition in Patients With Total Parenteral Nutrition (TPN)-Induced Cholestasis
Evaluation of Omegaven™ Parenteral Nutrition in Patients With Total Parenteral Nutrition (TPN)-Induced Cholestasis
The purpose of this study is to determine if established parenteral nutrition (PN) associated
 liver disease can be reversed or its progression halted by using a parenteral fat emulsion
 prepared from fish oil as measured by normalization of serum levels of hepatic enzymes and
 bilirubin.
The primary objective of this study is to evaluate the need for and time to small bowel
 transplantation or liver transplantation. This will be calculated as both the age at time of
 primary transplant as well as the length of time from initial evaluation to
 transplant.Secondary objectives are to determine if there are improvements in clinical
 measures associated with established parenteral nutrition- associated liver disease (PNALD).
 These will be determined by measurement of total and direct bilirubin levels, platelet count,
 serum albumin, and changes in both length and weight growth curves.
Inclusion Criteria:

 -  Patients must be enrolled in the Intestinal Rehabilitation Program at the University
 of Nebraska Medical Center, AND:

 -  Be unable to meet nutritional needs solely by enteral nutrition and be expected to
 require PN for at least another 30 days

 -  Have clinical evidence of parenteral nutrition associated liver disease (PNALD) as
 defined as a direct bilirubin of 2 mg/dl or more. A liver biopsy is desirable but not
 necessary for treatment

 -  Signed patient informed consent

 Exclusion Criteria:

 -  Parent or guardian or child unwilling to provide consent or assent

 -  Inability or unwillingness on the part of parent/guardian or child to follow clinical
 recommendations of the Intestinal Rehabilitation Program

 -  Allergies or clinical conditions precluding safe use of Omegaven™