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To many infants in the experimental group developed hypertriglyceridemia
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Higher Infusion | Experimental | 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. |
|
| Standard Infusion | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Fat Emulsions | Drug | Control Group: 0.5 grams/kg/day Experimental Group: 2 grams/kg/day |
|
| 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 |
| 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 |
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Inclusion Criteria:
Thirty-five infants will be randomized into the control group and thirty-five infants will be randomized into the experimental group.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kamlesh S Macwan, MD | University of Illinois College of Medicine at Peoria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Illinois at OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | United States |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Twelve infants were randomized into the experimental arm and 10 infants were randomized into the control arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | This study was ended early due to 100% of the infants in the experimental group developed hypertriglyceridemia of 200 mg/dl or greater | Posted | Number | participants | First 7 days of life |
|
There were no adverse events reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Serum Triglycerides | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kamlesh Macwan | OSF Saint Francis Medical Center | 309-624-0611 | kamlesh.s.macwan@osfhealthcare.org |
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| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D005217 | Fat Emulsions, Intravenous |
| ID | Term |
|---|---|
| D004655 | Emulsions |
| D003102 | Colloids |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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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 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Gestational Age | Mean | Standard Deviation | weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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. |
|
|
|
| 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. | Not Posted | First 2 weeks of life |
| 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. | Not Posted | First 14 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. | Not Posted | Entire hospital stay |
| Secondary | Initiation of Glucose | Infants were monitored to see if insulin was started to control hyperglycemia. | Not Posted | First 7 days of life |
| 0 |
| 19 |
| 0 |
| 19 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D044882 | Glucose Metabolism Disorders |
| D057947 |
| Parenteral Nutrition Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |