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

• Status: Terminated
• Trial end date: 2020-04-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fresenius Kabi
• Treatments: Fat Emulsions, Intravenous; Parenteral Nutrition Solutions; SMOFlipid; Soybean oil, phospholipid emulsion

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