Start Date
March 31, 2018
Primary Completion Date
March 31, 2020
Study Completion Date
March 31, 2021
Kabiven®
"Infusion should start at a low dose (i.e., 12.5 to 25 mL/kg, corresponding to 10.6 to 21.2 kcal/kg/day, 0.49 to 0.98 g lipids/kg/day, 0.41 to 0.83 g amino acids/kg/day and 1.2 to 2.4 g dextrose/kg/day) followed by stepwise increase to the individual target for PN calories.~The daily dose of the study PN should be infused at a constant rate over 20 to 24 hours.~Route of Administration: Infusion into a central vein. Duration of Treatment: Study treatment will last for a minimum of 5 and a maximum of 8 consecutive days. Study treatment will be stopped if oral and/or enteral intake covers 80% or more of caloric requirements. If the indication for PN continues after 8 study days, PN will continue per normal institution policy."
Compounded standard parenteral nutrition
"Infusion should start at a low dose (i.e., 12.5 to 25 mL/kg, corresponding to 10.6 to 21.2 kcal/kg/day, 0.49 to 0.98 g lipids/kg/day, 0.41 to 0.83 g amino acids/kg/day and 1.2 to 2.4 g dextrose/kg/day) followed by stepwise increase to the individual target for PN calories.~The daily dose of the study PN should be infused at a constant rate over 20 to 24 hours.~Route of Administration: Infusion into a central vein. Duration of Treatment: Study treatment will last for a minimum of 5 and a maximum of 8 consecutive days. Study treatment will be stopped if oral and/or enteral intake covers 80% or more of caloric requirements. If the indication for PN continues after 8 study days, PN will continue per normal institution policy."
The University of Chicago Medical Center, Chicago
Children's Mercy Hospital, Kansas City
Lead Sponsor
Fresenius Kabi
INDUSTRY