NCT02579265

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

A Prospective, Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants Requiring 28 Days of Parenteral Nutrition

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Fresenius Kabi · Industry
• Sex: All
• Age: 0 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Hospitalized Neonates and Infants, Expected to Require Parenteral Nutrition for 28 Days

Interventions

Type	Name	Description
DRUG	Smoflipid 20% (investigational lipid for parenteral nutrition)	Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Smoflipid 20% will be infused into a central or a peripheral vein.
DRUG	Intralipid® 20%	Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Intralipid® 20% will be infused into a central or peripheral vein.

Timeline

• Start date: 2015-12-01
• Primary completion: 2020-04-03
• Completion: 2020-04-10
• First posted: 2015-10-19
• Last updated: 2022-01-05
• Results posted: 2022-01-05

Locations

13 sites across 1 country: United States