at San Diego, California and other locations
study started
estimated completion



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.

Official Title

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


Hospitalized Neonates and Infants, Expected to Require Parenteral Nutrition for 28 DaysParenteral nutritionNeonatesInfantsLipid emulsionsIntravenousSoybean oil, phospholipid emulsionParenteral Nutrition SolutionsSmoflipid 20% (investigational lipid for parenteral nutrition)Intralipid® 20%Smoflipid 20%


You can join if…

  • 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

You CAN'T join if...

  • 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


  • UC San Diego Medical Center accepting new patients
    San DiegoCalifornia92103United States
  • Rady Children's Hospital San Diego accepting new patients
    San DiegoCalifornia92123United States


accepting new patients
Start Date
Completion Date
Fresenius Kabi
Phase 3
Study Type
Last Updated