Expanded Access of Omegaven IV Fat Emulsion to Infants and Children With PNALD

Exclusion Criteria

• •1. Documented cause of chronic liver disease other than parenteral nutrition associated liver disease.
• •2. An allergy to any seafood product, egg protein, and/or previous allergy to Omegaven.
• •3. Active coagulopathy characterized by ongoing bleeding or by a requirement for clotting factor replacement (e.g. fresh frozen plasma or cryoprecipitate) to maintain homeostasis.
• •4. Impaired lipid metabolism or severe hyperlipidemia with or without pancreatitis.(e.g. (triglycerides \> 1000mg/dl while receiving intralipid 1g/kg/day or less)
• •5. Unstable diabetes mellitus or hyperglycemia (Blood glucose \>200 mg/dL) at the time of initiation of Omegaven
• •6. Currently being treated for stroke, embolism, collapse and shock, myocardial infarction.
• •7. Cholestasis due to any reason other than parenteral associated liver disease
• •8. Active new infection at time of initiation of Omegaven
• •9. Hemodynamic instability (e.g. receiving vasopressors) at time of initiation of Omegaven.
• •10. The patient may not be enrolled in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team).
• •11. Known pregnancy.