Study to Assess Safety and Efficacy of Kabiven® in Pediatric Patients 2 to 16 Years of Age

PHASE4WithdrawnINTERVENTIONAL
0
Timeline

Start Date

March 31, 2018

Primary Completion Date

March 31, 2020

Study Completion Date

March 31, 2021

Conditions
Malnutrition
Interventions
DRUG

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."

DRUG

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."

Trial Locations (2)

60637

The University of Chicago Medical Center, Chicago

64108

Children's Mercy Hospital, Kansas City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Fresenius Kabi

INDUSTRY