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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
Study Diet
Enteral diet made of Nutrilon without lactose® fortified by concentration
干预措施: Nutrilon without lactose® fortified by concentration (Dietary Supplement)
Control Diet
Enteral diet made of Nutrilon without lactose® fortified by Maltodextrin and oil supplementation.
干预措施: Nutrilon without lactose® fortified by Maltodextrin and oil supplementation (Dietary Supplement)
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)