NCT03857646已完成4 期
The Effect of Lipid Emulsions on Free Fatty Acids and Free Bilirubin in Premature Newborns
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Free Bilirubin (UB) Serum Levels
研究概览
简要总结
The goal of this research study is to compare the levels of free fatty acids and free bilirubin between two intravenous lipid emulsion products in premature newborns.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 0 Days 至 8 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •premature newborns (<32 weeks gestation, stratified <28 weeks versus >28 weeks) <8 days of age
- •receiving lipid infusions <1 g/kg/day at enrollment
- •anticipated to be treated with 3 g/kg/day for a minimum of 48 hours.
排除标准
- •patients with direct hyperbilirubinemia >1.5 mg/dl
- •with suspected sepsis meeting Systemic inflammatory response syndrome (SIRS) criteria
- •undergoing treatment with a continuous infusion of morphine
- •with a continuous infusion of pressors (dopamine, dobutamine, epinephrine, etc.)
- •positive blood cultures
研究组 & 干预措施
Intralipid
Other
干预措施: Intralipid, 20% Intravenous Emulsion (Drug)
Soybean oil Medium-chain triglycerides Olive oil Fish Oil (SMOF) lipid
Other
干预措施: Soybean oil Medium-chain triglycerides Olive oil Fish Oil (SMOF) lipid (Drug)
结局指标
主要结局
Free Bilirubin (UB) Serum Levels
时间窗: second day of infusion at 3 g/kg/day
次要结局
- Free Fatty Acid (Total) Serum Level(second day of infusion at 3 g/kg/day)
- Unbound Free Fatty Acid (FFAu) Serum Level(second day of infusion at 3 g/kg/day)
- Number of Participants With Direct Bilirubin >1.8 Milligrams Per Deciliter (mg/dL)(first and/or second days of infusion at 3 g/kg/day)
- Number of Participants With Peak Serum Triglyceride Level >350 mg/dl(first or second days of infusion at 3 g/kg/day)
- Mean Serum Triglyceride Level(second day of infusion at 3 g/kg/day)
研究者
Meredith Collins
Physician
The University of Texas Health Science Center, Houston
研究点 (1)
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