Compassionate Use of Omegaven IV Fat Emulsion

Inclusion Criteria: * Two consecutive direct bilirubin levels of 2 mg/dl or more in a parenteral nutrition dependent infant or child (unable to meet nutritional needs solely by enteral nutrition) * Other causes of liver disease have been excluded. A liver biopsy is not necessary for treatment. * The patient must have utilized standard therapies to prevent the progression of the liver disease including reduction/removal of copper and manganese from daily PN, trial of enteral feeding if possible, and the use of ursodiol (i.e., Actigall®). Exclusion Criteria: * Documented causes of chronic liver disease other than parenteral nutrition associated liver disease * Proven severe advanced liver disease including cirrhosis on biopsy, varices, ascites. * An allergy to any seafood product, egg protein, and/or previous allergy to Omegaven® * Active coagulopathy characterized by ongoing bleeding or by a requirement for clotting factor replacement (e.g. fresh frozen plasma or cryoprecipitate) to maintain homeostasis * Impaired lipid metabolism or severe hyperlipidemia with or without pancreatitis * Unstable diabetes mellitus or hyperglycemia * Stroke, embolism, collapse and shock, recent MI * Cholestasis due to any reason other than parenteral associated liver disease * Active new infection at time of initiation of Omegaven® * Hemodynamic instability * The patient may not be enrolled in any other clinical trial involving an investigational agent (unless approved by the designated physic…