Intravenous Fat Emulsions and Premature Infants

This study has been terminated.
(To many infants in the experimental group developed hypertriglyceridemia)
Sponsor:
Information provided by (Responsible Party):
Kamlesh Macwan, OSF Healthcare System
ClinicalTrials.gov Identifier:
NCT01096446
First received: March 30, 2010
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Hypertriglyceridemia
Hyperglycemia
Drug: Intravenous Fat Emulsions

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tolerance of Higher Infusion Rates of Intravenous Fat Emulsions in Extremely Low Birthweight Infants During the First Week of Life

Resource links provided by NLM:


Further study details as provided by OSF Healthcare System:

Primary Outcome Measures:
  • Infants will maintenance of a serum triglyceride level of 200 mg/dl or less. [ Time Frame: First 7 days of life ] [ Designated as safety issue: Yes ]
    Each day the infants have a serum triglyceride level drawn to assess their tolerance of the intravenous fat emulsion being given.


Secondary Outcome Measures:
  • Regain birthweight [ Time Frame: First 2 weeks of life ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Infants were monitored to see if insulin was started to control hyperglycemia.


Enrollment: 11
Study Start Date: April 2008
Study Completion Date: July 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Intralipid 20%
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 Name: Intralipid 20%

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

Ages Eligible for Study:   up to 2 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01096446

Locations
United States, Illinois
Children's Hospital of Illinois at OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Sponsors and Collaborators
OSF Healthcare System
Investigators
Principal Investigator: Kamlesh S Macwan, MD University of Illinois College of Medicine at Peoria
  More Information

No publications provided

Responsible Party: Kamlesh Macwan, Neonatalogist, OSF Healthcare System
ClinicalTrials.gov Identifier: NCT01096446     History of Changes
Other Study ID Numbers: OSF-118
Study First Received: March 30, 2010
Last Updated: May 14, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hyperglycemia
Hypertriglyceridemia
Glucose Metabolism Disorders
Metabolic Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014