跳至主要内容
临床试验/NCT05163145
NCT05163145Unknown不适用

Risk Factor for Cholestasis in Neonates receivingTPN At Assiut University Children Hospital

Mayyada Elsayed Mohamed Hussien0 个研究点目标入组 50 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
主要终点
effect of TPN on neonatal liver

研究概览

简要总结

The aim of this study is to evaluate the risk factors of PNAC in neonates

详细描述

Neonates with prematurity,gastrointestinal dysfunction and very low birth weights are often intolerant to oral feeding.In such infants,the provision of nutrients via parenteral nutrition (PN)becomes necessary for short term survival,as well as long-term health. Wilmore and Dudrick first reported use of parenteral nutrition(PN) for an infant more than 40years ago Soon there after physicians recognized that PN was associated with significant liver changes.In the first reported case of parenteral nutrition-associated conjugated hyperbilirubinemia (PNAC) in a premature infant hepatomegaly was noted on the18thday of fat-free PN and worsened until death on the71st day of life The hyperbilirubinemia manifest in PNAC is thought to occur from impaired hepatic bileflow, an adynamic gallbladder,and an upsurge in release of conjugated bilirubin as an infant matures.Atbirth,preterm neonates havereduced activity of the uridine diphosphate glucuronosyl transferase1A1 liver enzyme(UDPGT)that catalyzes conjugation of bilirubin As the infant develops,UDPGT becomes more functional, increasing hepatocyte efficiency for conjugation.Thus,in combination with cholestasis,and neonatal intestinal absorption of unconjugated bilirubin,more conjugated bilirubin is made available to pass from the liver into circulation. Parenteral nutrition associated cholestasis (PNAC) is the most common form of liver damage in neonates while receiving parenteral nutrition(PN).Its prevalence was reported between10%and 60%in NICU Cholestasisis acommonly described complication of PN. Its etiology is not fully understood and is thought to be multifactorial Proposed mechanisms included altered bile salt metabolisms secondary to prematurity and toxic effect of PN components on the liver the presence or absence of specific components in parenteral nutrition solutions most certainly contributing to the disease mechanism,and gastrointestinal systems .Aggravating factors such as sepsis and duration of bowel rest have also been described

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
1 Day 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Neonates who received PN for ≥14 days

排除标准

  • :Neonates with major congenital anomaly, cholestasis at birth,diseases associated with cholestasis (i.e.,inborn errors of metabolism,viral hepatitis,cystic fibrosis and any primary cholestatic liver diseases)that were diagnosed while hospitalized.the possibility of surgical causes of conjugated hyperbilirubinemia(such as biliary atresia,choledochalcyst on abdominal ultrasonography,and hepatobiliary scintigraphy

结局指标

主要结局

effect of TPN on neonatal liver

时间窗: baseline

TPN associated cholestasis in neonates

次要结局

未报告次要终点

研究者

发起方
Mayyada Elsayed Mohamed Hussien
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mayyada Elsayed Mohamed Hussien

Mayyada Elsayed Mohamed Hussien

Assiut University

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