Effects of Medium and Long Chain Fat Emulsions and SMOF Fat Emulsions on PNALD and Oxidative Stress in Premature Infants: a Randomized, Double-blind Controlled Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 66
- 主要终点
- Change of liver function indexes
研究概览
简要总结
Abnormal liver function or cholestasis is the result of multiple factors, include low birth weight, smaller than gestational age, preterm birth, infection, lipid emulsion (LE) in parenteral nutrition (PN), insufficient enteral nutrition (EN) etc. Most are inevitable, but the LEs in PN can be selected. So the investigators compare two LEs, and want to see if the SMOF LE can improve hepatic index in preterm infants.
详细描述
For preterm infants, especially for very or extremely low birth weight infants, it's impossible to achieve total enteral feeding in short time. So, PN has played an important role to sustain normal life. But, it also has an adverse effect on liver namely parenteral nutrition-associated liver disease (PNALD). LE(s) in PN has been showed to result in PNALD. So changing the type of LEs has been an ideal solution.
Two types of lipid emulsions are currently used for pediatric patients: one LE(the second generation) is composed of 50% long-chain triacylglycerols (LCTs) and 50% medium-chain triacylglycerols (MCTs), prepared from soybean oil and coconut oil respectively. A new LE (SMOF) contains 30% LCTs, 30% MCTs, 25% olive oil, and 15% fish oil. SMOF is rich in omega-3 polyunsaturated fatty acids which derived from fish oil. It may reduce inflammation in premature infants, prevent or treat cholestasis, and reduce oxidative stress.
Because of the different compositions, they have different effect on liver, inflammation, oxidative stress, etc. Therefore, the investigators designed a prospective, randomized and double-blind study to compare the different LEs (MCTs/LCTs and SMOF), so as to select a more suitable fat emulsion for premature infants in order to improve clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature infants (gestational age < 32 weeks) with birth weight < 1500g were admitted to NICU of Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China within 24 hours after birth
- •No contraindications to parenteral nutrition
- •Expected PN support for 14 days or more
- •Parents or guardians agree
排除标准
- •Parenteral nutrition support was provided prior to enrollment
- •EN calorie for 10% or more
- •Congenital intestinal structural/functional abnormalities
- •Liver function damage caused by viral hepatitis, genetic metabolism and abnormal biliary tract
- •Congenital or acquired immunodeficiency
- •Complex congenital heart disease
研究组 & 干预措施
SMOF lipid emulsion
the SMOF lipid emulsion is SMOFlipid.
干预措施: SMOFlipid (Drug)
MCT/LCT lipid emulsion
the MCT/LCT lipid emulsion is Lipofundin.
干预措施: Lipofundin (Drug)
结局指标
主要结局
Change of liver function indexes
时间窗: change from baseline in liver function indexes at 7 days and 14 days
liver enzyme in u/L
Change of bilirubin indexes
时间窗: change from baseline in bilirubin indexes at 7 days and 14 days
bilirubin in μmol/L
次要结局
- Change of malondialdehyde(change from baseline in malondialdehyde at 7 days and 14 days)
- Change of superoxidase dismutase(change from baseline in superoxidase dismutase at 7 days and 14 days)
- Change of inflammatory factors(change from baseline in fatty acid at 7 days and 14 days)
研究者
Ying Wang
head of department
Shanghai Jiao Tong University School of Medicine