A prospective, open label, single arm, multicenter, interventional, study to assess the efficacy and tolerability of early enteral nutrition in hospitalized patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- 1) Ease of achieving desired target, no. of days required to achieve the target and no. of days of ICU stay.
研究概览
简要总结
This study is a prospective open label, single arm, multicenter, interventional, study to assess the efficacy and tolerability of early enteral nutrition in hospitalized patients at participating centers aged in between 18 to 75 years in about 40 adult patients that will be conducted in India. The primary objectives is to study the impact of tube feeding supplement (Early enteral nutrition formula) for achieving the target Macro Nutrients levels and the number of days required to reach the target Macro Nutrients levels in hospitalized patients who are hemodynamically stabilized and requiring Enteral feeding for minimum 3 days. A total of 40 adult patients admitted to hospital will be enrolled for the study across different centers in India. Ease of achieving desired target, no. of days required to achieve the target and no. of days of hospital stay from Day 1 till Day 14th will be assessed in the study endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •To study the impact of tube feeding supplement for achieving the target Macro Nutrients levels 2) To study the number of days required to reach the target Macro Nutrients levels.
排除标准
- •To study the impact of EN supplement on total protein, micronutrient levels such as Zn, Vitamin C, Mg, potassium and Phosphorous.
- •To study the impact of tube feeding supplement events of abdominal pain, distension, vomiting and diarrhea after EN supplement 3) To assess the number and reasons of interruptions during the tube feeding and ease of titration of the formula 4) To assess the impact of tube feeding supplement on hematological parameters from baseline to the end of the study.
- •To evaluate the palatability of the formulation in patients shifted to ward’s, through oral supplementation.
结局指标
主要结局
1) Ease of achieving desired target, no. of days required to achieve the target and no. of days of ICU stay.
时间窗: Baseline Visit, Day 1, Day 2, Day 3, Day 4-8, Day 8-14, End of study assessment.
次要结局
- 1) Improved vital status(2) No Interruptions to feeding)