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.
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
- 否
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
Xu Zhuoming
Director of CICU
Shanghai Jiao Tong University School of Medicine
