Tolerance of Higher Infusion Rates of Intravenous Fat Emulsions in Extremely Low Birthweight Infants During the First Week of Life
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Number of Infants Serum Triglyceride Level Higher Than 200 mg/dl
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 2 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Intravenous Fat Emulsions (Drug)
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.
干预措施: Intravenous Fat Emulsions (Drug)
结局指标
主要结局
Number of Infants Serum Triglyceride Level Higher Than 200 mg/dl
时间窗: 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.
次要结局
- Regain Birthweight(First 2 weeks of life)
- Infants Will Achieve 90 Calories/Kilogram/Day(First 14 days of Life)
- Maintain Appropriate for Gestational Age Status at Discharge(Entire hospital stay)
- Initiation of Glucose(First 7 days of life)
研究者
Kamlesh Macwan
Neonatalogist
OSF Healthcare System