drugset / Trial / NCT03563222
Safety and Efficacy Study to Compare Smoflipid and Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Intralipid | Other / unclassified | — | Intravenous |
| Subject | SMOFlipid | Other / unclassified | — | Intravenous |