Intravenous Fat Emulsions and Premature Infants

Stopped early · Not applicable

Conditions studied: Hypertriglyceridemia, Hyperglycemia

In brief

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.

Key facts

Study ID

NCT01096446

Run by

OSF Healthcare System

People needed

19

Starts

2008-04-01

Expected to finish

2010-07-01

Last updated by the study team

2014-11-20

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All infants will be recruited who are admitted to the Neonatal Intensive Care Unit at Children's Hospital of Illinois.
• A total of 70 ELBW infants classified as Appropriate for Gestational Age (AGA) and who are between 500 grams to 750 grams in weight at birth.
• Thirty-five infants will be randomized into the control group and thirty-five infants will be randomized into the experimental group.

You may not qualify if…

• Have a baseline triglyceridemia above 200 mg/dl prior to beginning the study.
• Who are classified as Small for Gestational Age (SGA)
• Who have any congenial anomalies, and/or,
• Who are septic

Where it is running

• Children's Hospital of Illinois at OSF Saint Francis Medical Center — Peoria, Illinois, United States

Full record on ClinicalTrials.gov

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