Clinical trial NCT01096446: Intravenous Fat Emulsions and Premature Infants
Official title: Tolerance of Higher Infusion Rates of Intravenous Fat Emulsions in Extremely Low Birthweight Infants During the First Week of Life
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypertriglyceridemia
Hyperglycemia
Lead sponsor: OSF Healthcare System
Sponsor class: OTHER
First posted: 2010-03-31
Enrollment: 19
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Number of Infants Serum Triglyceride Level Higher Than 200 mg/dl
timeFrame: First 7 days of life
Secondary outcomes:
measure: Regain Birthweight
timeFrame: First 2 weeks of life
measure: Infants Will Achieve 90 Calories/Kilogram/Day
timeFrame: First 14 days of Life
measure: Maintain Appropriate for Gestational Age Status at Discharge
timeFrame: Entire hospital stay
measure: Initiation of Glucose
timeFrame: First 7 days of life
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Children's Hospital of Illinois at OSF Saint Francis Medical Center
state: Illinois
Study officials:
affiliation: University of Illinois College of Medicine at Peoria
name: Kamlesh S Macwan, MD
role: PRINCIPAL_INVESTIGATOR
References: