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

Stopped early · Phase 3

Conditions studied: Hospitalized Neonates and Infants, Expected to Require Parenteral Nutrition for 28 Days

In brief

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.

Key facts

Study ID

NCT02579265

Run by

Fresenius Kabi

People needed

204

Starts

2015-12-01

Expected to finish

2020-04-10

Last updated by the study team

2022-01-05

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 may not qualify 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

Where it is running

• Lucile Packard Children's Hospital — Palo Alto, California, United States
• UC San Diego Medical Center — San Diego, California, United States
• Rady Children's Hospital San Diego — San Diego, California, United States
• Yale - New Haven Children's Hospital — New Haven, Connecticut, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Mount Sinai Hospital — New York, New York, United States
• Steven & Alexandra Cohen Children's Medical Center of NY — New York, New York, United States
• The Children's Hospital at OU Medical Center — Oklahoma City, Oklahoma, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
• Vanderbilt Children's Hospital — Nashville, Tennessee, United States
• Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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