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

A Prospective, Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants Requiring 28 Days of Parenteral Nutrition

To show the superiority in safety of Smoflipid over Intralipid® as measured by the number of study patients in each treatment group with conjugated bilirubin exceeding 2 mg/dL during the first 28 days of study treatment, confirmed by a second sample collected 7 days after the first sample.

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