Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition: A Two-Center, Double-Blind Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 44
- 主要终点
- Incidence of Neonatal Cholestasis
研究概览
简要总结
The purpose of this study is to compare the effects of a multicomponent lipid emulsion containing 30% soybean oil, 30% medium-chain triglycerides, 25% olive oil, and 15% fish oil with a conventional pure soybean oil lipid emulsion on the incidence of neonatal cholestasis, infant growth, infant morbidity and the biochemical assessment of liver enzymes.
详细描述
Intravenous lipid emulsions are the major sources of non-protein energy and provision of required essential fatty acids.
The reference lipid emulsion, widely used for many years, is prepared from soybean oil, which is rich in omega 6 polyunsaturated fatty acids and phytosterols that contribute to hepatotoxicity and their metabolites result in pro-inflammatory eicosanoid production.
Existing evidence strongly supports a pathogenetic role of inflammation and oxidative stress on parenteral nutrition associated liver disease.
Subsequent development of lipid emulsions has focused on reducing the amount of soybean oil and replacing it with other oils.Moreover the omega 3 fatty acids from fish oil are metabolized to anti-inflammatory eicosanoids which can prevent inflammatory responses.
A novel multicomponent lipid emulsion may prevent liver injury, improve growth and decrease morbidity in preterm infants.
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, Investigator)
入排标准
- 年龄范围
- 24 Weeks 至 30 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inborn infants with a gestational age of less than 30 weeks
- •Who required parenteral nutrition for at least 7 days
排除标准
- •Evidence of congenital infection
- •Perinatal asphyxia
- •Congenital anomalies
- •Severe IVH
- •Thrombocytopenia
- •Shock or circulation failure
- •Renal or hepatic disorders.
研究组 & 干预措施
study group
multicomponent lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.
干预措施: multicomponent lipid emulsion (Drug)
control group
pure soybean oil lipid emulsion(intralipid) was administered at a dose of 1gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.
干预措施: pure soybean oil lipid emulsion (Drug)
结局指标
主要结局
Incidence of Neonatal Cholestasis
时间窗: 3 months
direct bilirubin level of more than 2 mg/dL
次要结局
- Weight Gain(up to 24 weeks)
- Height Gain(up to 24 weeks)
- Neonatal Morbidities(4 months)
- Incidence of Extrauterine Growth Restriction (EUGR)(up to 24 weeks)
- Head Circumference Gain(up to 24 weeks)
- Assessment of Aspartate Aminotransferase (AST)(3 month)
- Assessment of Gamma Glutamyltranspeptidase (GGT)(3 month)
- Assessment of Alanine Aminotransferase (ALT)(3 month)
研究者
Dr Wilaiporn Techasatid
Head of Neonatology
Thammasat University