Increase Infusion Rates of Intravenous Fat Emulsions

Hyperglycemia Clinical Trial

Official title: Tolerance of Increased Infusion Rates of Intravenous Fat Emulsions in Very Low Birth Weight Infants During the First Week of Life

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperglycemia
• Hypertriglyceridemia

• NCT number: NCT00516997
• Study type: Interventional
• Source: OSF Healthcare System
• Status: Completed
• Phase: N/A
• Start date: June 2005
• Completion date: February 2007