Compassionate Use of Omegaven IV Fat Emulsion

Inclusion Criteria:

- Diagnosis of life threatening PNALD

- Dependent on Parenteral Nutrition for caloric needs

- Expected to require PN for at least another 30 days

- Other causes of liver disease have been excluded

- GI/Liver service is involved in patient care

- standard therapies for the treatment of PNALD must have been utilized prior to
initiating omegaven.

- Under the care of an attending Neonatologist in the NICU

- Must be at least 2 months of age

Exclusion Criteria:

- Not a NICU patient

- Younger than 2 months of age

- Expected to be weaned off of parenteral nutrition within 30 days

- have other documented causes of liver disease

- have signs of proven severe advanced liver disease

- Allergy to seafood, egg protein and/or previous allergy to Omegaven

- active coagulopathy, impaired lipid metabolism or severe hyperlipidemia with or
without pancreatitis, stoke, embolism, hemodynamic collapse or shock, recent MI,
cholestasis due to any reason other than PNALD, active new infection at time of
initiation of Omegaven, hemodynamic instability or if unable to tolerate the
necessary laboratory monitoring

- must not be enrolled in another clinical trial involving an investigational agent
(unless approved by the designated physicians).

- Parent or legal guardian must be willing to provide consent.