Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants
What is the purpose of this trial?
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.
- Trial withFresenius Kabi DEutschland GmbH
- Start Date07/06/2017
- End Date10/30/2017
- Last Updated02/22/2018
- Study HIC#1510016597