COntinuous Versus INtermittent Enteral tube feeding in Critically ill children-An open- label randomized controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- 1.To find the time taken(in days/hours) to reach target calorie (≥70% of calculated calories as per WHO age sex equation after initiation of feeds) and target protein of 1.5 g/kg/day.
研究概览
简要总结
After receiving written informed consent, all critically ill children who meet the inclusion criteria and are admitted to the PICU of AIIMS Raipur, aged between 1 month and ≤ 15 years, will be enrolled in the study. Following enrollment, participants will be randomly assigned to one of the two groups: Group A or Group B. Using WHO reference charts (11), target protein and calorie requirements will be calculated for both groups. Subjects in group A will receive continuous enteral naso-gastric feeding via syringe pump over 24 hours, with a interruption of maximum 2 hours. Subjects in group B will receive intermittent bolus enteral tube feedings every three hourly as supplied by department of dietics,AIIMS Raipur. Enrolled subjects in the trial who are readmitted to the PICU within 48 hours of being discharged and who are still inside the original 7-day randomization window will be continued on the same nutritional method to which they were initially randomly allocated during their PICU stay.Enrolled children are followed up telephonically at 28 day post discharge to know the status of child.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Month(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •All children between the age of 1 month to less than 15 years, who are likely to stay in PICU for more than 48 hours, not being able to take food orally, enteral nutrition through naso gastric or oro gastric tube for mor than 4 days using standard food formula.
排除标准
- •1.Children with altered Nasogastric tube aspirate 2.Children with enterocolitis 3.Children with surgical abdomen 4.Children with skull base injury.
- •5.Children with short bowel syndrome 6.Expected death within 24 hours
- •Readmission to PICU more than 48 hours after already having been included in the CONVINCE trial.
- •Transfer from another PICU after stay of more than or equal to 3 days or having received enteral nutrition.
结局指标
主要结局
1.To find the time taken(in days/hours) to reach target calorie (≥70% of calculated calories as per WHO age sex equation after initiation of feeds) and target protein of 1.5 g/kg/day.
时间窗: Until 1 week of initiation of enteral tube feeding.
次要结局
- 1. To find out the incidence of feeding intolerance,glucose variability Hypoglycemia less than 60gm per dl and hyperglycemia more than 180 mg per dl(2. Incidence and cause of feeding interruption)
研究者
Akhila Gujarathi
AIIMS Raipur