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临床试验/NCT01683162
NCT01683162Unknown4 期

Effects of Parenteral Nutrition With Different Lipid Emulsions in Preterm Infants

Wei Cai1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2012年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
150
试验地点
1
主要终点
lipometabolism

研究概览

简要总结

Previous studies have suggested that olive oil-based emulsion is safe and well tolerated in preterm infants, a showed efficacy and a good clinical and biological safety profile. The objective of this study was to assess the effects of a new olive-oil based lipid emulsion compared with the traditional lipid emulsions.

详细描述

For a number of years, lipid emulsions have been used in the nutritional support of surgical and critically ill patients, with the aim of supplying substrates to meet energy demands and providing building blocks for wound healing and tissue repair. Two types of lipid emulsions are currently used for adult as well as pediatric patients: one lipid emulsions prepared from soybean oil that are composed of long-chain triacylglycerols (LCTs), 62% of which are polyunsaturated fatty acids (PUFAs), and the other lipid emulsions composed of 50% medium-chain triacylglycerols (MCTs) and 50% LCT soybean oil. A new lipid emulsion prepared from a mixture of soybean oil and olive oil contains only LCTs and has a lower proportion (20%) of PUFAs and 60% monounsaturated fatty acids (MUFAs). There are so many investigations with olive oil-based emulsion including in-vitro studies, animal studies, and infusion studies in healthy subjects and in various patient groups. In-vitro and animal studies demonstrate that the impairment of immune function, especially of T cell responses, that occurs with soybean oil-based emulsions is avoided with ClinOleic. Studies in infants and adults have consistently shown that olive oil-based emulsion increases the oleic acid content of blood lipids and that it avoids the depletion of long chain n-6 PUFA derivatives of linoleic acid that is seen with soybean oil-based emulsion. The less unsaturated nature of olive oil-based emulsion compared will possibly decrease oxidative stress. Further studies are required to test their beneficial effect from olive oil consumption in preterm infants.

The investigators designed a double-blind, randomized clinical trial to performed the effect of lipometabolism, oxidative stress and clinical outcomes of olive oil , MCY/LCT and LCT lipid emulsions.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
1 Day 至 1 Year(Child)
性别
All
接受健康志愿者

入选标准

  • Infants of both genders
  • Hospitalized
  • The parent of the infant agreed to participate by signing an informed consent form
  • Infants admitted hospital within 72 hours after birth(gestational age<37 weeks)
  • Birth weight <= 2000g
  • No PN support contraindications
  • Parenteral nutrition for 14 days or more
  • The parent of the infant is to sign an informed consent form prior to enrollment

排除标准

  • Receiving PN before screening
  • EN caloric>10%
  • Obstruction jaundice
  • Suspected or identified biliary tract atresia
  • Neonatal hepatitis
  • Infants with liver markers >2 times normal levels
  • Infants with renal markers >2 times normal levels
  • Congenital metabolic situations
  • Identified as having major chromosomal disease
  • CMV, virus hepatitis and syphilis infection
  • Congenital or acquired immune deficiency

研究组 & 干预措施

Olive oil lipid emulsion

Experimental

the olive oil lipid emulsion is ClinOleic

干预措施: ClinOleic (Drug)

MCT/LCT lipid emulsion

Experimental

the MCT/LCT lipid emulsion is Lipofundin

干预措施: Lipofundin (Drug)

LCT lipid emulsion

Experimental

the LCT lipid emulsion is Intralipid

干预措施: Intralipid (Drug)

结局指标

主要结局

lipometabolism

时间窗: Change from Baseline in fatty acid at 7 days and 14 days

fatty acid

次要结局

  • oxidative stress(Change from Baseline in liver function at 7 days and 14 days)

研究者

发起方
Wei Cai
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Wei Cai

vice-president

Shanghai Jiao Tong University School of Medicine

研究点 (1)

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