NCT01139853已完成早期 1 期
Post-Operative Impact of Nasogastric Tubes on Rates of Emesis in Infants Diagnosed With Pyloric Stenosis: A Prospective, Randomized Controlled Pilot Trial
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Feasibility
研究概览
简要总结
The overall objective of this research study is to determine the effect of a pre-operatively placed nasogastric tube compared to no nasogastric tube, on post-operative emesis rates and postoperative length of stay in infants with a primary diagnosis of pyloric stenosis treated with pyloromyotomy. This study will also examine the feasibility data of the pilot data to develop estimates of treatment effect of a pre-operative nasogastric tube on post-operative rate of emesis and length of stay to be used to determine the sample size of the definitive trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female infant ≤ 6 months of age
- •Primary diagnosis of Pyloric Stenosis confirmed by ultrasound
- •Amendable to circumumbilical pyloromyotomy
- •Amendable to a minimum size 10 French nasogastric tube
- •Able to undergo general anesthesia
- •Parent or legal guardian able to give free and informed consent
排除标准
- •Contraindicated for circumumbilical pyloromyotomy
- •Contraindicated for a size 10 French nasogastric tube
- •Prematurity before 35 weeks' gestation
- •Bronchopulmonary dysplasia
- •Viral infection in the past 7 days
- •Cardiac malformation
- •Patent ductus arteriosis
- •Previous abdominal surgery
- •Concurrent surgical procedure scheduled
- •Parent or legal guardian unable to read, speak and understand English
- •Co-enrolled in a different interventional trial
结局指标
主要结局
Feasibility
时间窗: 2 years
次要结局
- post-operative length of stay(1 year)
- rates of post-operative emesis(1 year)
研究者
研究点 (2)
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