drugset / Trial / NCT03563222

Safety and Efficacy Study to Compare Smoflipid and Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age

NCT03563222

Phase 4 Terminated 1 enrolled Fresenius Kabi
RandomizedParallel-groupTriple-blindSupportive care

Summary

Evaluate the safety and efficacy of Smoflipid compared to standard of care lipid emulsion Intralipid 20% administered via a central vein in pediatric patients 3 months to 16 years of age who require parenteral nutrition for at least 90 days and up to 1 year.

Timeline

Start
2019-12-18
Primary completion
2020-11-12
Completion
2022-07-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Intralipid Other / unclassified Intravenous
Subject SMOFlipid Other / unclassified Intravenous