Study Results
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View full resultsBasic Information
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TERMINATED
NA
19 participants
INTERVENTIONAL
2008-04-30
2010-07-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Intravenous Fat Emulsions
Control Group: 0.5 grams/kg/day Experimental Group: 2 grams/kg/day
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.
Intravenous Fat Emulsions
Control Group: 0.5 grams/kg/day Experimental Group: 2 grams/kg/day
Interventions
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Intravenous Fat Emulsions
Control Group: 0.5 grams/kg/day Experimental Group: 2 grams/kg/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Who are classified as Small for Gestational Age (SGA)
* Who have any congenial anomalies, and/or,
* Who are septic
1 Day
2 Days
ALL
No
Sponsors
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OSF Healthcare System
OTHER
Responsible Party
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Kamlesh Macwan
Neonatalogist
Principal Investigators
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Kamlesh S Macwan, MD
Role: PRINCIPAL_INVESTIGATOR
University of Illinois College of Medicine at Peoria
Locations
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Children's Hospital of Illinois at OSF Saint Francis Medical Center
Peoria, Illinois, United States
Countries
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Other Identifiers
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OSF-118
Identifier Type: -
Identifier Source: org_study_id