Trial
NCT02579265
Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants
Phase IIITERMINATEDEFFICACY/FUTILITYConfidence: MEDIUM
Sponsor
Fresenius Kabi
Collaborators
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Condition
Hospitalized Neonates and Infants, Expected to Require Parenteral Nutrition for 28 Days
Intervention
Smoflipid 20% (investigational lipid for parenteral nutrition)
Why stopped
Outcome of a planned interim analysis was that the sample size required to show superiority was too high to be feasible. Fresenius Kabi requested termination to the FDA on 17 Jan 2020. FDA accepted termination by written response on 16 Apr 2020.
Provenance
Dataset: 2026-07-02 • Source: ClinicalTrials.gov API v2 • Last update: 2022-01-05