Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Associated Hepatic Injury

Inclusion Criteria: * Patients must be 2 months -10 years of age. * Patients who are PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least another 30 days * Patients considered eligible for study participation must have parenteral nutrition associated liver disease (PNALD) as defined by a direct bilirubin of \>2.0mg/dL. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment. * 2 consecutive direct bilirubin test results \>2.0mg/dL * The patient must have failed standard therapies to prevent the progression of liver disease such as surgical treatment, cyclic TPN, avoiding overfeeding, reduction/removal of copper and manganese from TPN, advancement of enteral feeding, and use of ursodiol (Actigall). * Subjects who are currently under treatment for PNALD with Compassionate Use Omegaven and have a direct Bilirubin of\< 2, but who remain TPN dependent and require continued therapy with Omegaven. Exclusion Criteria: * Other known causes of chronic liver disease (hepatitis C, cystic fibrosis, biliary atresia and alpha 1 anti-trypsin deficiency) * Enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team) * The parent, guardian, or child is unwilling to provide consent or assent * Allergy to any fish product, egg protein, and/or previous allergy to Omegaven * Active coagulopathies char…