Intravenous Fat Emulsions and Premature Infants

Tolerance of Higher Infusion Rates of Intravenous Fat Emulsions in Extremely Low Birthweight Infants During the First Week of Life

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.

Study Overview

• Status: Terminated
• Conditions: Hyperglycemia; Hypertriglyceridemia
• Intervention / Treatment: Drug: Intravenous Fat Emulsions

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Peoria, Illinois, United States, 61637
      • Children's Hospital of Illinois at OSF Saint Francis Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 days (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Intravenous Fat Emulsions; Control Group: 0.5 grams/kg/day Experimental Group: 2 grams/kg/day; Other Names: Intralipid 20%
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.	Drug: Intravenous Fat Emulsions; Control Group: 0.5 grams/kg/day Experimental Group: 2 grams/kg/day; Other Names: Intralipid 20%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Infants Serum Triglyceride Level Higher Than 200 mg/dl	Each day the infants have a serum triglyceride level drawn to assess their tolerance of the intravenous fat emulsion being given.	First 7 days of life

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Regain Birthweight	Infants in both groups weights were monitored to determine if giving higher infusions of intravenous fat emulsion helped the infants regain their birthweight sooner.	First 2 weeks of life
Infants Will Achieve 90 Calories/Kilogram/Day	Monitored the calorie intake of infants to see which group was able to acheive 90 cal/kg/day from the total parenteral nutrition.	First 14 days of Life
Maintain Appropriate for Gestational Age Status at Discharge	Recorded all infant's weights at discharge and plotted the anthropometric values on the Fenton Growth Charts.	Entire hospital stay
Initiation of Glucose	Infants were monitored to see if insulin was started to control hyperglycemia.	First 7 days of life

Collaborators and Investigators

• Sponsor: OSF Healthcare System
• Investigators: Principal Investigator: Kamlesh S Macwan, MD, University of Illinois College of Medicine at Peoria

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (ACTUAL): May 1, 2010
• Study Completion (ACTUAL): July 1, 2010

Study Registration Dates

• First Submitted: March 30, 2010
• First Submitted That Met QC Criteria: March 30, 2010
• First Posted (ESTIMATE): March 31, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): November 20, 2014
• Last Update Submitted That Met QC Criteria: November 19, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hyperglycemia; Hypertriglyceridemia; Pharmaceutical Solutions; Parenteral Nutrition Solutions; Soybean oil, phospholipid emulsion; Fat Emulsions, Intravenous
• Other Study ID Numbers: OSF-118