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

Trial ID or NCT#

NCT02579265

Status

not recruiting iconNOT RECRUITING

Purpose

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

Eligibility Criteria

Ages Eligible for Study: Older than 0 Weeks
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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
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Investigator(s)

Katherine Rachel McCallie

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Contact

Kari McCallie, MD
650-723-5711

View on ClinicalTrials.gov