Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants
Condition: Hospitalized Neonates and Infants, Expected to Require Parenteral Nutrition for 28 Days
Intervention: Smoflipid 20% (investigational lipid for parenteral nutrition); Intralipid® 20%
Intervention description: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Smoflipid 20% will be infused into a central or a peripheral vein.; Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Intralipid® 20% will be infused into a central or peripheral vein.
Intervention MeSH terms: Soybean oil, phospholipid emulsion; SMOFlipid; Fat Emulsions, Intravenous
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 204.0
Sex: All
Minimum age: 0 Weeks
Healthy volunteers: No
Keywords: Parenteral nutrition; Neonates; Infants; Lipid emulsions; Intravenous

Summary:

      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.
    

Eligibility criteria:

        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