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Intravenous Fat Emulsions and Premature Infants

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ClinicalTrials.gov Identifier: NCT01096446
Recruitment Status : Terminated (To many infants in the experimental group developed hypertriglyceridemia)
First Posted : March 31, 2010
Results First Posted : November 20, 2014
Last Update Posted : November 20, 2014
Sponsor:
Information provided by (Responsible Party):
Kamlesh Macwan, OSF Healthcare System

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hypertriglyceridemia
Hyperglycemia
Intervention Drug: Intravenous Fat Emulsions
Enrollment 19
Recruitment Details Infants with a birthweight < 750 grams were recruited from April 2008 through March 2010 at the neonatal intensive care unit at at the Children's Hospital of Illinois at OSF Saint Francis Medical Center Peoria, IL.
Pre-assignment Details Thirty-five infants were deemed eligible for the study of which 13 infants were excluded due to one parent refused, 12 other infants were started on TPN prior to obtaining informed consent.
Arm/Group Title Higher Infusion Standard Infusion
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 12 10
Completed 9 [1] 10
Not Completed 3 0
Reason Not Completed
Death             1             0
Protocol Violation             2             0
[1]
One infant was SGA; one infant had a congenital anomaly; and one discontinued medical management
Arm/Group Title Standard Infusion Higher Infusion Total
Hide Arm/Group Description Infants randomized into the experimental 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. Infants randomized into the control 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. Total of all reporting groups
Overall Number of Baseline Participants 10 12 22
Hide Baseline Analysis Population Description
Twelve infants were randomized into the experimental arm and 10 infants were randomized into the control arm.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 12 participants 22 participants
<=18 years
10
 100.0%
12
 100.0%
22
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 10 participants 12 participants 22 participants
23.7  (0.68) 24.33  (1) 24  (0.5)
[1]
Measure Description: Gestational Age
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 12 participants 22 participants
Female
5
  50.0%
9
  75.0%
14
  63.6%
Male
5
  50.0%
3
  25.0%
8
  36.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 12 participants 22 participants
10 12 22
1.Primary Outcome
Title Number of Infants Serum Triglyceride Level Higher Than 200 mg/dl
Hide Description Each day the infants have a serum triglyceride level drawn to assess their tolerance of the intravenous fat emulsion being given.
Time Frame First 7 days of life
Hide Outcome Measure Data
Hide Analysis Population Description
This study was ended early due to 100% of the infants in the experimental group developed hypertriglyceridemia of 200 mg/dl or greater
Arm/Group Title Higher Infusion Standard Infusion
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 9 10
Measure Type: Number
Unit of Measure: participants
9 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Higher Infusion, Standard Infusion
Comments Four infants(44%)in the control group developed hypertriglyceridemia (>200 mg/dl) while 100% of the infants in the experimental group developed hypertriglyceridemia (>200 mg/dl) during the first week of life.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The Chi Square satistical calculation was used for analysis.
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Regain Birthweight
Hide Description Infants in both groups weights were monitored to determine if giving higher infusions of intravenous fat emulsion helped the infants regain their birthweight sooner.
Time Frame First 2 weeks of life
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Infants Will Achieve 90 Calories/Kilogram/Day
Hide Description Monitored the calorie intake of infants to see which group was able to acheive 90 cal/kg/day from the total parenteral nutrition.
Time Frame First 14 days of Life
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Maintain Appropriate for Gestational Age Status at Discharge
Hide Description Recorded all infant's weights at discharge and plotted the anthropometric values on the Fenton Growth Charts.
Time Frame Entire hospital stay
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Initiation of Glucose
Hide Description Infants were monitored to see if insulin was started to control hyperglycemia.
Time Frame First 7 days of life
Outcome Measure Data Not Reported
Time Frame There were no adverse events reported.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Serum Triglycerides
Hide Arm/Group Description Serum triglycerides <201 mg/dl in both arms were considered to be normal. If serum triglycerides in either arm was above 201 mg/dl than the Intralipids was decreased based on the algorithm for adjusting IVFE when hypertriglyceridemia occured.
All-Cause Mortality
Serum Triglycerides
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Serum Triglycerides
Affected / at Risk (%)
Total   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Serum Triglycerides
Affected / at Risk (%)
Total   0/19 (0.00%) 
This study was terminated early because 100% of the infants in the experimental grouped developed hypertriglyceridemia (>200 gm/dl), which did not support our primary hypothesis.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Kamlesh Macwan
Organization: OSF Saint Francis Medical Center
Phone: 309-624-0611
Responsible Party: Kamlesh Macwan, OSF Healthcare System
ClinicalTrials.gov Identifier: NCT01096446     History of Changes
Other Study ID Numbers: OSF-118
First Submitted: March 30, 2010
First Posted: March 31, 2010
Results First Submitted: November 25, 2013
Results First Posted: November 20, 2014
Last Update Posted: November 20, 2014