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临床试验/NCT04609358
NCT04609358已完成不适用

Efficacy and Safety of the Implementation of an Algorithm for Enteral Nutrition Support Compared With Traditional Practice in Children With Congenital Heart Disease: Randomized Clinical Trial, Simple Blind.

Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 256 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
256
试验地点
1
主要终点
Malnutrition recovery

研究概览

简要总结

The purpose of this trial is to evaluate the efficacy and safety of the implementation of an algorithm for enteral nutrition support compared with usual standard practice in children with malnutrition status with congenital heart disease

详细描述

In many developing countries, pediatric cardiac programs are not fully established, and nutrition support algorithm is lack. Therefore, this study aimed to evaluate the the efficacy and safety of the implementation of an algorithm for enteral nutrition support compared with usual standard practice in children with malnutrition status with congenital heart disease. The usual standard practice for feeding often interrupted by retention in the gut and then choose the parenteral nutrition support especially in the patients with unstable hemodynamic status. Actually tiny and continuous feeding would improve the gut function and reach the adequate energy supply.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
1 Day 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • weight-for-age of z-score <-2; or length-for-age of z score <-2; or weight-for-length of z score <-2

排除标准

  • Any patient with congenital genetic metabolic diseases

结局指标

主要结局

Malnutrition recovery

时间窗: 1 year

Malnutrition was assessed as recovering from malnutrition

次要结局

  • Feeding intolerance(1 year)

研究者

发起方
Shanghai Jiao Tong University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xu Zhuoming

Director of CICU

Shanghai Jiao Tong University School of Medicine

研究点 (1)

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