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

"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."

"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."