Bolus Versus Continuous Feeding Regimens Post Gastrostomy Tube Placement
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 97
- 试验地点
- 2
- 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)
研究组 & 干预措施
Bolus
Bolus: Total volume of feedings is determined by the amount of formula required to meet calorie and protein needs, which is determined by a Registered Dietitian. Volume of each bolus is determined by dividing the total volume of feeding by the desired number of feedings per day:
If child is less than 6 months: 8 feeds/day If child is 6-12 months 6 feeds/day If child is 12 months or greater: 5 feedings/day Rate of feeds is determine by the rate needed to infuse each bolus over 1 hour. Patient to remain NPO. Once at goal, if able to take PO, may offer orally first with remainder of goal volume over the remainder of the hour.
干预措施: Bolus feeding schedule following gastrostomy tube placement (Procedure)
Continuous
Continuous: Total volume of feedings is determined by the amount of formula required to meet calorie and protein needs, which is determined by a Registered Dietitian. Rate of feeds is determined by dividing total volume of feedings by 24 hours. Patient is to remain NPO. Once at goal, if able to take PO, may offer hourly amount orally, but only 2x per day.
干预措施: Continuous chimney feeds following gastrostomy tube placement (Procedure)
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