Efficacy and Safety of Refeeding in Preterm Infants With Enterostomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The change of citrulline level during the study period
研究概览
简要总结
Refeeding is an extracorporeal stool transport from the proximal stoma end to the distal end of stoma. Refeeding may be beneficial in preventing malabsorption, electrolyte imbalance, cholestasis and atrophy of the distal intestine. Investigators are focused on evaluating the efficacy and safety of the practice of refeeding in preterm infants with enterostomy. Clinical data including weight gain, total parenteral nutrition (TPN) usage, and other laboratory findings will be collected. Serial citrulline levels during refeeding procedure and pathologic specimens of bowel (at the time of stoma closure) will be collected for evaluating bowel adaptation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 35 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants who are less than 35 weeks gestational age at birth and get stomas after laparotomy
排除标准
- •Congenital gastrointestinal malformation
- •Blind pouch (after laparotomy)
- •Refeeding procedure related infection
- •Hemodynamic instability requiring inotropic or vasopressor agents (if the condition improves, the refeeding procedure can be restarted again)
结局指标
主要结局
The change of citrulline level during the study period
时间窗: up to 6 months of corrected age
4 time points: at the time of full enteral feeding (\>120 cc/kg/day), 4 weeks later after full enteral feeding, at the time of stoma closure operation, 12 weeks later after closure operation
次要结局
- The pathologic findings after refeeding procedure(up to 8 weeks of corrected age)
- the number of days on parenteral nutrition(up to 8 weeks of corrected age)
- The weight gain(up to 6 months of corrected age)
- Adverse events during refeeding procedure(up to 8 weeks of corrected age)
研究者
Ee-Kyung Kim
Professor
Seoul National University Hospital