NCT02006953终止不适用
Bolus Versus Continuous Feeding Regimens Post Gastrostomy Tube Placement
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 97
- 试验地点
- 4
- 主要终点
- Rate of gastrostomy tube leakage
研究概览
简要总结
The purpose of this study is to determine the best way to feed children after they have a gastrostomy tube placed. The study compares bolus feeding to continuous feeding.
详细描述
This study will consist of a prospective, randomized comparison of bolus versus continuous enteral feeding protocols in pediatric patients with gastrostomy tubes
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
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Less than 18 years of age
- •Admitted for gastrostomy tube placement, with or without Nissen Fundoplication
排除标准
- •Immunocompromised patients
- •Short Bowel Syndrome (SBS)
结局指标
主要结局
Rate of gastrostomy tube leakage
时间窗: 8 weeks
Symptoms are rated by parents on a daily diary for the first 4 weeks following g-tube placement, and then on a weekly diary for the next 4 weeks.
次要结局
- Feeding changes(8 weeks)
- Retching(8 weeks)
- Unscheduled clinic/ER visits/calls(8 weeks)
- G-tube infection(8 weeks)
- Weight(8 weeks)
- Emesis(8 weeks)
- Venting beyond recommendations(8 weeks)
- Time to goal feeds(8 weeks)
研究者
Steven W. Bruch
M.D., MSc., Clinical Associate Professor
University of Michigan
研究点 (4)
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