Intravenous Fat Emulsions and Premature Infants
Intravenous Fat Emulsions and Premature Infants
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.
ELBW infants will be randomized into either the control group or the experimental group.

 The control group will receive standardized care which consists of receiving TPN within 24 to
 36 hours of life. The control group will be given the standardized dosage of IVFE starting at
 0.5 grams/kg/day in the TPN and have IVFE advanced daily by 0.5 grams/kg/day until a goal
 rate of 3 grams/kg/day is achieved. The experimental group will receive TPN within 24 to 36
 hours of life. For these infants, IVFE will begin at 2 grams/kg/day. For the experimental
 group, Intralipid will be increased by 0.5 grams/kg/day until a goal rate of 3 grams/kg/day
 is achieved.

 An informed consent form (Appendix A), to be signed by the parent or guardian, will be
 obtained for all infants before they are enrolled into this study. Assent waiver is requested
 on the study participants because they are infants.

 All infants enrolled in this study will have their laboratory data monitored at least daily
 during the first week of life. A baseline triglyceride will be drawn prior to beginning TPN
 to verify that their serum triglyceride levels are <200 gm/dl. This will include a daily
 lipid profile panel used to evaluate the serum triglyceride levels and the tolerance of the
 two different IVFE infusion rates. Lipid tolerance will be defined as infants having a serum
 triglyceride levels at < 200 mg/dl. Lipid intolerance will be defined as infants having a
 serum triglyceride of 201 mg/dl or greater. If lipid intolerance occurs, IVFE will be
 decreased by the following standard of care:

 Serum Triglycerides Levels Changes Intralipid in TPN by:

 150-200 mg/dl Keep at current IVFE order 201-249 mg/dl decrease by 1 grams/kg/day 250-299
 mg/dl decrease by 1.5 gram/kg/day 300 mg/dl or greater Reduce Intralipid to 0.5 grams/kg/day
 to prevent essential fatty acid deficiency (EFAD). If hypertriglyceridemia persists (300
 mg/dlor greater) over 24 hours keep IVFE at 0.5 gm/kg/day to prevent EFAD.

 The total caloric intake will be calculated and collected daily for both groups. The calorie
 intake will be specified as total kilocalories per kilogram (kcal/kg/day). The goal calorie
 intake for both groups will be 90 kcal/kg/day. The kcal/kg index will be calculated by a
 Registered Dietitian, who is assigned to the Neonatal Intensive Care Unit.

 All collected data will be presented as a mean +/- SD. The statistical significance will be
 defined by a p value < 0.05.
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