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:
Participant gender:
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.