Overview

Intravenous Fat Emulsions and Premature Infants

Status:
Terminated
Trial end date:
2010-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
OSF Healthcare System
Treatments:
Fat Emulsions, Intravenous
Soybean oil, phospholipid emulsion
Criteria
Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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