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

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

Outcome

Missed primary endpoint

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.”

paper (primary outcome) was 2.4% (2 of 83) with CO-ILE and 3.8% (3 of 78) with SOLE PMID 39374788 ↗

paper risk ratio: 0.59; 95% confidence interval [CI]: 0.09, 3.76 PMID 39374788 ↗

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.