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临床试验/NCT03136900
NCT03136900终止不适用

Controlled, Randomized, Double-blind, Monocentric Clinical Study Evaluating the Impact on the Nitrogen Balance, Autonomy, Safety and Tolerance of Enteral Diets Made of Nutrilon Without Lactose® Fortified by Concentration Versus by Maltodextrin and Oil Supplementation, After Surgery for Congenital Heart Disease, in Children Aged Zero to Two Years Old

Queen Fabiola Children's University Hospital2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2017年5月3日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
41
试验地点
2
主要终点
positive nitrogen balance

研究概览

简要总结

An adequate nutritional support after a cardiac surgery enhances the morbidity and mortality.

After a cardiac surgery, the energy expenditure is estimated to be around 55 kcal/kg/d. The caloric intake is not the only important nutritional variable in PICU. The protein intake objective is around 1,5g/kg/d in order to reduce muscular catabolism.

The aim of this study is to compare the impact of an isocaloric enteral diet, either fortified by milk concentration (in order to increase the protein intake) or by a supplement of maltodextrin and oil in children from 0 to 2 years, after surgery for congenital heart disease.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
— 至 2 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children from 0 to 2 years undergoing cardiac surgery (corrective or palliative) for congenital heart surgery, with or without extracorporeal circulation
  • Expected stay of 5 days in PICU after surgery
  • Expected need of invasive ventilation for 48h after surgery
  • Expected need for enteral feeding during 5 days.
  • Obtaining the informed consent of the child's legal guardian after being informed of the goals, benefits and potential risks of this study

排除标准

  • Medical indications for specific diet

结局指标

主要结局

positive nitrogen balance

时间窗: Day 5 post operative

次要结局

  • duration of enteral feeding(up to 120 days post operative)
  • length of hospital stay in hospital(up to 120 days post operative)
  • duration of invasive or non-invasive ventilatory support(up to 120 days post operative)
  • length of hospital stay in intensive care unit(up to 120 days post operative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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