NCT00497289已完成2 期
Double-blind, Prospective, Randomized Comparison of a Medium Chain Triglycerides (MCT)/Long Chain Triglycerides (LCT)/Fish Oil (FO) Containing 20% Lipid Emulsion With a MCT/LCT Emulsion (20%) for Parenteral Nutrition in Preterm Infants
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Safety: Alanine Transaminase (ALT)
研究概览
简要总结
The study shall provide evidence for the save and efficient use of a fish oil containing lipid emulsion in parenteral nutrition of preterm infants.Safety will be assessed by monitoring hepatological and hematological laboratory parameters. Efficiency will be assessed by monitoring of inflammatory parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 5 Hours 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •prematurity (birth weight 500 - 1500 g)
- •postnatal age <= 72 h
- •need for cumulative parenteral energy supply of at least 70% during study duration
- •signed informed consent form
排除标准
- •simultaneous participation in another clinical study
- •platelet count below 50000 /ml
- •cumulative enteral energy supply of > 30 % during study duration
- •serious congenital infections and/or diseases
- •serious metabolic disturbances
- •severe cranial bleeding (Papile III, IV)
- •need for administration of blood products
- •contra-indication for iv lipid administration
- •withdrawal of consent
研究组 & 干预措施
1
Experimental
Lipidem 20 %
干预措施: Lipidem 20% (Drug)
2
Active Comparator
Lipofundin MCT/LCT 20%
干预措施: Lipofundin MCT/LCT 20 % (Drug)
结局指标
主要结局
Safety: Alanine Transaminase (ALT)
时间窗: on Study day -1 & 6
Change in ALT between pre/post treatment
Efficacy: Interleukin-6 (IL-6)
时间窗: on Study day -1 & 6
Change of IL-6 Measurement pre/post treatment
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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