Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment

Inclusion Criteria:

1. Patient's parent(s) or legal guardian(s) has provided a signed and dated InformedConsent Form (ICF).

2. Pediatric patient (<18 years) has been diagnosed with PNAC, defined as direct orconjugated bilirubin (DBil) ≥ 2.0 mg/dL with no other known cause of liverdysfunction at the time of enrollment and is expected to require Omegaven treatmentfor at least eight weeks.

3. Patient has oral or enteral feeding intolerance or at least one gastrointestinaldisorder requiring PN.

Exclusion Criteria:

1. Patient has received Omegaven within four weeks before inclusion in the study

2. Patient has any other known cause of chronic liver disease such as hepatitis C,cystic fibrosis, biliary atresia, alpha-1-antitrypsin deficiency, passive hepaticcongestion due to heart failure, etc.

3. Patient has known cirrhosis (liver biopsy is not required under this protocol).

4. Patient has been previously diagnosed with, or has prior evidence of, portal veinthrombosis.

5. Patient has previously received a liver-only or liver-inclusive transplant.

6. Patient has hemodynamic instability due to any major cardiac anomaly.

7. Patient has a major life-threatening disease (e.g., sepsis requiring high-dosevasopressors, acute respiratory distress syndrome, veno-occlusive disease, cancer).

8. Patient has multi-organ failure, septic shock, hypotension requiring pressortherapy, persistent pulmonary hypertension requiring inhaled nitric oxides, orrequires extracorporeal membrane oxygenation (ECMO) or similar intervention.

9. Patient has renal failure and requires renal replacement therapy.

10. Patient has a severe hemorrhagic disorder.

11. Patient has severe hyperlipidemia or a severe disorder of lipid metabolismcharacterized by hypertriglyceridemia (i.e., serum triglyceride level > 1,000mg/dL).

12. Patient has a record of EFAD before inclusion in the study

13. Patient has been diagnosed with or is suspected to have an inborn error ofmetabolism.

14. Patient has a known hypersensitivity to fish or egg protein or to any of the activeingredients or excipients of Omegaven.

15. Patient is subject to treatment limitation.

16. Patient is enrolled in any other study with an investigational medicinal productduring the course of the current study.