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).
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.
Full Title of Study: “Tolerance of Higher Infusion Rates of Intravenous Fat Emulsions in Extremely Low Birthweight Infants During the First Week of Life”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: May 2010
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.
- Drug: Intravenous Fat Emulsions
- Control Group: 0.5 grams/kg/day Experimental Group: 2 grams/kg/day
Arms, Groups and Cohorts
- Experimental: Higher Infusion
- Infants randomized into the experimental group will receive 2 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
- Other: Standard Infusion
- Infants randomized into the control group will receive 0.5 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
Clinical Trial Outcome Measures
- Number of Infants Serum Triglyceride Level Higher Than 200 mg/dl
- Time Frame: First 7 days of life
- Each day the infants have a serum triglyceride level drawn to assess their tolerance of the intravenous fat emulsion being given.
- Regain Birthweight
- Time Frame: First 2 weeks of life
- Infants in both groups weights were monitored to determine if giving higher infusions of intravenous fat emulsion helped the infants regain their birthweight sooner.
- Infants Will Achieve 90 Calories/Kilogram/Day
- Time Frame: First 14 days of Life
- Monitored the calorie intake of infants to see which group was able to acheive 90 cal/kg/day from the total parenteral nutrition.
- Maintain Appropriate for Gestational Age Status at Discharge
- Time Frame: Entire hospital stay
- Recorded all infant’s weights at discharge and plotted the anthropometric values on the Fenton Growth Charts.
- Initiation of Glucose
- Time Frame: First 7 days of life
- Infants were monitored to see if insulin was started to control hyperglycemia.
Participating in This Clinical Trial
- 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.
- 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
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: 2 Days
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- OSF Healthcare System
- Provider of Information About this Clinical Study
- Principal Investigator: Kamlesh Macwan, Neonatalogist – OSF Healthcare System
- Overall Official(s)
- Kamlesh S Macwan, MD, Principal Investigator, University of Illinois College of Medicine at Peoria
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