Hepatic Function and Bile Acid in Preterm Infants Receiving Parenteral Lipids Emulsion
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- liver function
研究概览
简要总结
The etiology of parenteral nutrition-associated cholestasis(PNAC)although elusive is thought to be multifactorial, and proposed theories also include problems arising from lipid emulsions, leading us to explore alternative products available elsewhere.So we compare the different fat emulsion, and want to see if the olive oil lipid emulsions can improve hepatic tolerance in preterm infant.
详细描述
Parenteral nutrition (PN) has been widely and successfully used in the pediatric population for more than 40 years, the most serious and significant life-threatening complication today continues to be parenteral nutrition-associated cholestasis(PNAC). Parenteral nutrition-associated cholestasis is indeed the most worrisome complication because it is difficult to treat and may progress to eventual cirrhosis and liver failure namely parenteral nutrition-associated liver disease (PNALD).
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), 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 polyunsaturated fatty acids(PUFAs)and 60% monounsaturated fatty acids (MUFAs). So we compare the different fat emulsion, and want to see if the olive oil lipid emulsions can improve hepatic tolerance in preterm infant.
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
- Triple (Participant, Care Provider, 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
- •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
- •Enteral nutrition(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
- •Cytomegaoviyns(CMV), virus hepatitis and syphilis infection
- •Congenital or acquired immune deficiency
研究组 & 干预措施
LCT lipid emulsion
the LCT lipid emulsion is Intralipid
干预措施: ClinOleic (Drug)
LCT lipid emulsion
the LCT lipid emulsion is Intralipid
干预措施: Intralipid (Drug)
Olive oil lipid emulsion
the olive oil lipid emulsion is ClinOleic
干预措施: ClinOleic (Drug)
Olive oil lipid emulsion
the olive oil lipid emulsion is ClinOleic
干预措施: Intralipid (Drug)
结局指标
主要结局
liver function
时间窗: Change from Baseline in fatty acid at 7 days and 14 days
Total Bile Acid(TBA),alanine aminotransferase(ALT),aspartate aminotransferase(AST),alkaline phosphatase(AKP),γ-glutamyl transpeptidase(GGT),total bilirubin(Tbi),Direct bilirubin(Dbi)
次要结局
- bile acid(Change from Baseline in fatty acid at 7 days and 14 days)
研究者
Wei Cai
vice-president
Shanghai Jiao Tong University School of Medicine