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临床试验/NCT02475759
NCT02475759已完成不适用

Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics. A Randomized Controlled Trial

Ain Shams University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2017年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
anthropometric and laboratory measure

研究概览

简要总结

Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics. A randomized controlled trial.

详细描述

Nutritional Prehabilitation Program and Cardiac Surgery in Pediatrics. A randomized controlled trial to compare the outcome of malnourished congenital heart surgery patients who randomly received nutritional rehabilitation program 2 weeks and 1 week before surgical intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •The study included all infants with CHD, admitted to the cardiothoracic unit for either palliative or corrective surgery, and suffering from nutritional deficiencies with moderate or severe malnutrition .
  • •Infants received long-term nutritional prehabiliatation. Those with congenital or acquired anomaly of the gastrointestinal tract; multiple congenital anomalies; chromosomal, metabolic,or endocrine diseases; any systemic illness; or fever or infection within 1 wk before the study entry were excluded

排除标准

  • 未提供

研究组 & 干预措施

two weeks prehabilitation group

Active Comparator

Nutritional perioperative prehabilitation program for two weeks in malnourished congenital heart disease children

干预措施: Nutritional perioperative prehabilitation program for two weeks (Dietary Supplement)

one week prehabilitation group

Active Comparator

Nutritional perioperative prehabilitation program for one week in malnourished congenital heart disease children

干预措施: Nutritional perioperative prehabilitation program for one week (Dietary Supplement)

结局指标

主要结局

anthropometric and laboratory measure

时间窗: admission

anthropometric and laboratory measure

daily feeding characteristics

时间窗: admission

daily feeding characteristics

次要结局

  • length of ICU stay(3weeks)
  • duration of mechanical ventilation and extubation timing(3 weeks)
  • postoperative vital stability, surgical complication,nosocomial sepsis,inotropes withdrawal(admission)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rania Ali El-Farrash

principal investigator

Ain Shams University

研究点 (1)

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