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

Phase 3 Terminated 204 enrolled Fresenius Kabi

RandomizedParallel-groupQuadruple-blindSupportive care

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.

Timeline

Start: 2015-12
Primary completion: 2020-04-03
Completion: 2020-04-10

Publications

Abrams SA, Ernst KD, Weitkamp JH, Mascarenhas M, Anderson-Berry A, Rudolph J, Ling CY, Robinson DT, Shores D, Hair AB, Lai J, Lane B, McCallie KR, Levit O, Kim JH. Safety and Efficacy of a Composite Lipid Emulsion with Fish Oil in Hospitalized Neonates and Infants Requiring Prolonged Parenteral Nutrition - A Randomized, Double-Blind, Multicenter, Controlled Trial. J Nutr. 2024 Dec;154(12):3615-3625. doi: 10.1016/j.tjnut.2024.10.005. Epub 2024 Oct 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Intralipid	Other / unclassified	3 g/kg	Intravenous
Subject	SMOFlipid	Other / unclassified	3 g/kg	Intravenous

Indications

No indication recorded.