Increase Infusion Rates of Intravenous Fat Emulsions
The purpose of this study to evaluate the tolerance of providing very low birth weight infants increased infusion rates of intravenous fat emulsions (IVFE) in their total parenteral nutrition solutions during the first week of life.
The hypothesis was as follows: Very Low Birth Weight Infants (VLBW) between 750 grams to 1500 grams will tolerate a higher infusion rate of IVFE within the first days of life (days 1-7) as evidenced by maintenance of a serum triglyceride level of 200 mg/dl or less.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Tolerance of Increased Infusion Rates of Intravenous Fat Emulsions in Very Low Birth Weight Infants During the First Week of Life|
- To evaluate the tolerance of VLBW infants to receiving higher than standard infusion rates of Intralipid emulsion during the first week of life. Triglycerides (200 gm/dl or less) [ Time Frame: For 7 days after starting parenteral nutrition ]
- To achieve meeting estimated nutritional needs of VLBW infants for total parenteral nutrition (TPN) of 90 calories/kg/day within the first week of life. [ Time Frame: 7 days after starting parenteral nutrition ]
- To achieve a return to birth weight for VLBW infants significantly sooner. [ Time Frame: Two weeks after birth ]
- To maintain blood sugar levels of VLBW infants at less than 200mg/dl. [ Time Frame: 7 days after starting parenteral nutrition ]
|Study Start Date:||June 2005|
|Study Completion Date:||February 2007|
Experimental: High Lipids
Infants in the experimental group received 2 grams/kilogram/day (gm/kg/d) of IVFE in their parenteral nutrition solution.
Other: fat emulsions
Intravenous Fat Emulsions were increased by 0.5 grams/kg/day daily until goal 3 gm/kg/d
No Intervention: Low Lipids
IVFE were started at 0.5 gm/kg/day in parenteral nutrition.
Other: fat emulsions
IVFE were increased daily by 05 gm/kg/d until goal of 3 gm/kg/d
After inform consent was obtains from parents a sealed envelope was opened to reveal which study group they were allocated to. The experimental group (High Lipids) were started at 2 gm/kg/d of IVFE in the parenteral nutrition solution. The control group (Low Lipids) were started at 0.5 gm/kg/d of IVFE in the parenteral nutrition solution. Serum triglycerides were drawn daily. If serum triglyceride was 200 gm/dl or less the IVFE were increased by 0.5 gm/kg/d until a goal of 3 gm/kg/d were achieved in both groups. If hypertriglyceridemia occurred (201 gm/dl or greater) IVFE were decreased by study standard of care.
After infant had been on parenteral nutrition for 7 days checking daily triglycerides was stopped.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516997
|United States, Illinois|
|Children's Hospital of Illinois|
|Peoria, Illinois, United States, 61637|
|Principal Investigator:||Kamlesh S Macwan, MD||University of Illinois College of Medicine at Peoria|