NCT01778101已完成2 期
A Pilot Study - Lansoprazole in Preterm Infants With Gastroesophageal Reflux
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- impedance pH monitoring
研究概览
简要总结
This study is pilot study to evaluate safety and efficacy of lansoprazole in preterm infants with gastroesophageal reflux documented by 24hr pH impedance monitoring
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm infant
- •documented gastrointestinal reflux by 24hr pH monitoring
排除标准
- •unstable vital sings
- •congenital anomaly in upper gastrointestinal tract incuding esophagus
- •drug history of H2 blocker during last 1 week
- •medication of warfarin, carbamazepine, phenytoin, rifampin
- •renal or hepatic dysfunction
- •inappropriate clinical conditions judged by researchers
研究组 & 干预措施
lansoprazole
Experimental
lansoprazole 1mg/kg twice a day for 14days
干预措施: Lansoprazole (Drug)
结局指标
主要结局
impedance pH monitoring
时间窗: day14
number of acid exposure percent time of acid exposure mean acid clearance time Acid Reflux Composite Score Analysis ; total time in reflux, episodes of 5min, composite score Bolus exposure(impedance); acid percent time, weakly acid percent time, weakly alkaline percentime Reflux Episodes activity Reflux Symptom Index Reflux Symptom Sensitivity Index Reflux Symptom Association Probability
次要结局
- Symtomts of reflux_d5(day 5)
- impedance pH monitoring_d10(day10)
- impedance pH monitoring_d5(day5)
- Symtomts of reflux_d14(Symtomts of reflux_d14 day 14)
- Symtomts of reflux_d10(day 10)
研究者
Han-Suk Kim
Professor
Seoul National University Hospital
研究点 (1)
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