Intravenous Fat Emulsions and Premature Infants

Hyperglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01096446
• Other study ID #: OSF-118
• Status: Terminated
• Phase: N/A
• First received: March 30, 2010
• Last updated: November 19, 2014
• Start date: April 2008
• Est. completion date: July 2010

Study information

• Verified date: November 2014
• Source: OSF Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: July 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Days

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperglycemia
• Hypertriglyceridemia

Intervention

Drug:
• Intravenous Fat Emulsions
Control Group: 0.5 grams/kg/day Experimental Group: 2 grams/kg/day

Locations

Country	Name	City	State
United States	Children's Hospital of Illinois at OSF Saint Francis Medical Center	Peoria	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
OSF Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Initiation of Glucose	Infants were monitored to see if insulin was started to control hyperglycemia.	First 7 days of life	Yes