Comparison of protocol based continuous and intermittent tube feeding in mechanically ventilated critically ill children – Open Label Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Time required to reach target calories which is defined as 70 percent of calories out of total calorie requirement calculated by using the age and sex specific WHO formula
研究概览
简要总结
Malnutrition is a major problem in children admitted to critical care unit. Enteral nutritional delivery plays an important role in determining the clinical outcomes in this population. As per recent guidelines by ASPEN (American Society of Parenteral and Enteral Nutrition), in critically ill children enteral nutrition should be initiated < 48 hours of admission to PICU and 2/3rd of energy requirement must be achieved in first week which is beneficial. However due to factors like feed intolerance, disease severity, gut injury and barriers of enteral nutrition, there is a delay in initiation and progression in nutritional delivery. Of the factors mentioned above feed intolerance is the major one delaying the achievement of target calories and protein. One way of improving feed tolerance is changing the mode of delivery from intermittent bolus to continuous.
Studies in critically ill children comparing continuous and intermittent tube feeding are lacking and two earlier studies have controversial results. Studies in critically ill adults have inconsistent results. No clear recommendation has been made for the mode of delivery of enteral nutrition in critically ill children. Given the magnitude of problem of malnutrition in critically ill children and outcome benefits achieved by supplementation of target calorie and protein in them, it necessary to have evidence on mode of delivery of enteral nutrition. Although intermittent feeding is more physiological, continuous feeding which constantly delivers the nutrition without increasing the stress on dysfunctional gut in critically ill may have additional advantages. In view of insufficient evidence and possibility of achieving target nutritional requirement earlier in continuous feeding with better feed tolerance than intermittent feeding, we plan to conduct a study to compare the two modes of tube feeding in critically ill children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Month(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Critically ill children, age 1 month (corrected age).
- •18 years admitted in PICU Who are mechanically ventilated (invasive /non-invasive) with or without inotropic support Who would be started on enteral nutrition through naso/oro-gastric tube.
排除标准
- •Children with known malabsorption syndrome and chronic diarrhea Children on peritoneal dialysis or hemodialysis Children who are admitted for elective pre- and post- procedure care Enteral feeding initiated before admission to PICU.
结局指标
主要结局
Time required to reach target calories which is defined as 70 percent of calories out of total calorie requirement calculated by using the age and sex specific WHO formula
时间窗: 10 days
次要结局
- Children who achieve primary outcome and continue to receive the target calorie for 48 hrs without interruption(10 days)
- Children who achieve 70% of calorie requirement on day 7 of PICU stay(7 days)
- Time required to reach target protein i.e. 1.5g/kg/day as per ASPEN 2017(10 days)