Hyperglycemia, Hypertriglyceridemia
Conditions
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.
Interventions
DRUGIntravenous Fat Emulsions
Control Group: 0.5 grams/kg/day Experimental Group: 2 grams/kg/day
Sponsors
OSF Healthcare System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 2 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Infants Serum Triglyceride Level Higher Than 200 mg/dl | First 7 days of life | Each day the infants have a serum triglyceride level drawn to assess their tolerance of the intravenous fat emulsion being given. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Regain Birthweight | First 2 weeks of life | 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 | First 14 days of Life | 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 | Entire hospital stay | Recorded all infant's weights at discharge and plotted the anthropometric values on the Fenton Growth Charts. |
| Initiation of Glucose | First 7 days of life | Infants were monitored to see if insulin was started to control hyperglycemia. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Standard Infusion 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. | 10 |
| Higher Infusion 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. | 12 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Protocol Violation | 2 | 0 |
Baseline characteristics
| Characteristic | Higher Infusion | Standard Infusion | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 12 Participants | 10 Participants | 22 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 24.33 weeks STANDARD_DEVIATION 1 | 23.7 weeks STANDARD_DEVIATION 0.68 | 24 weeks STANDARD_DEVIATION 0.5 |
| Region of Enrollment United States | 12 participants | 10 participants | 22 participants |
| Sex: Female, Male Female | 9 Participants | 5 Participants | 14 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
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.
Time frame: First 7 days of life
Population: This study was ended early due to 100% of the infants in the experimental group developed hypertriglyceridemia of 200 mg/dl or greater
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Higher Infusion | Number of Infants Serum Triglyceride Level Higher Than 200 mg/dl | 9 participants |
| Standard Infusion | Number of Infants Serum Triglyceride Level Higher Than 200 mg/dl | 4 participants |
Comparison: 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.p-value: 0.011Chi-squared
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.
Time frame: First 14 days of Life
Secondary
Initiation of Glucose
Infants were monitored to see if insulin was started to control hyperglycemia.
Time frame: First 7 days of life
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.
Time frame: Entire hospital stay
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.
Time frame: First 2 weeks of life