Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants

Inclusion Criteria:

- Neonates and infants, expected to require parenteral nutrition (PN) for 28 days

- Postmenstrual age ≥ 24 weeks

- Birth weight ≥ 750g

- Gastroschisis, duodenal, jejunal or ileal atresia, volvulus, spontaneous intestinal
perforation or necrotizing enterocolitis (Bell's stage 2B or higher)

- At least 80% of nutritional needs at baseline received by PN

- Signed and dated informed consent obtained from at least one parent or legal guardian

Exclusion Criteria:

- Conjugated bilirubin > 0.6 mg/dL

- Any known pre-, intra- or posthepatic complication increasing conjugated bilirubin
levels > 0.6, mg/dL during study participation

- Suspected liver disease or liver damage based on either aspartate aminotransferase
(AST), alanine aminotransferase (ALT), or gamma-glutamyl transferase (GGT) exceeding
2.5x upper limit of normal range

- Active bloodstream infection demonstrated by positive blood culture at screening

- Cystic fibrosis

- Meconium ileus

- Serum triglyceride levels > 250 mg/dL

- Cyanotic congenital heart defect

- Severe renal failure with serum creatinine > 2.0 mg/dL

- History of shock requiring vasopressors

- Anasarca

- Extracorporeal Membrane Oxygenation (ECMO)

- Known inborn errors of metabolism

- Known congenital viral infection

- Unlikely to survive longer than 28 days

- Known hypersensitivity to fish-, egg-, soya- or peanut protein or to any of the active
substances or excipients