drugset / Trial / NCT01096446

Intravenous Fat Emulsions and Premature Infants

NCT01096446

Terminated 19 enrolled OSF Healthcare System
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to study the tolerances of Extremely Low Birthweight Infants who are born at less than 750 grams who are started at a higher infusion rate of intravenous lipid emulsions (2 gm/kg/day). These infants will be compared with a control group who are at the standard lipid emulsion infusion rate (0.5 gm/kg/day). hypothesis: A. Objectives of this project. Null Hypothesis: There will not be a significant difference for Extremely Low Birth Weight Infants (ELBW) \<750 grams being able to tolerate a higher infusion rate of Intravenous Fat Emulsions (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. Alternative Hypothesis: There will be a significant difference (p\<0.05) for Extremely Low Birth Weight Infants (ELBW) \<750 grams being able to tolerate a higher infusion rate of Intravenous Fat Emulsions (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.

Timeline

Start
2008-04
Primary completion
2010-05
Completion
2010-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Intralipid Other / unclassified 3 g/kg Intravenous