Impact of Fish Oil-enriched Intravenous Lipid Emulsion in Parenteral Nutrition of Phospholipid Fatty Acid Composition and Inflammatory Response in Infants After Gastrointestinal Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Fatty Acids Composition
研究概览
简要总结
This study aim to compare the impact of fish oil-enriched intravenous lipid emulsion to standard Intravenous lipid emulsion on fatty acid composition and inflammatory response (IL-1β and IL-8 levels) in infants after gastrointestinal surgery. Our hypothesis is the fish oil-enriched intravenous lipid emulsion can improve the fatty acid composition and lower the inflammatory response.
详细描述
This study is conducted in infants post gastrointestinal surgery that requires parenteral nutrition for at least 3 days. Subjects are classified into two groups. Group 1 received standard IVFE and group 2 received ω-3-enriched IVFE. The type of intravenous standard and omega-3-enriched fat emulsion used in this study are Lipofundin 20% and SMOFlipid 20%, respectively, both administered for three consecutive days after surgery (72 hours) in 1-4 gram/kilogram/day dosing. The inflammatory response (IL-1β and IL-8 levels) and fatty acid composition are checked from blood plasma. Blood examination is done before the surgery and 3 days after the surgery.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Hour 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •willing to participate in this study (through informed consent)
- •undergo gastrointestinal surgery
- •get parenteral nutrition for at least 3 days
排除标准
- •chronic diseases
- •allergic to fish, egg, soy and/or nut proteins
结局指标
主要结局
Fatty Acids Composition
时间窗: 3 days (before surgery and after surgery)
The percentage of fatty acid consentration from total fatty acids
Inflammatory response
时间窗: 3 days (before surgery and after surgery)
Interleukin 1b and Interleukin 8 levels
次要结局
- C reactive Protein(3 days (before surgery and after surgery))
- Albumin(3 days (before surgery and after surgery))
- Hemoglobin(3 days (before surgery and after surgery))
- Leukocyte(3 days (before surgery and after surgery))
研究者
Meta Herdiana Hanindita, dr., Sp.A (K)
MD, Pediatrician (Consultant)
Dr. Soetomo General Hospital