48 Hoursesophagal pH-monitoring With and Without Gaviscon
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of pathological GERD
研究概览
简要总结
At a esophagal pH-monitoring will the classic 24-hour measurement be extended to 48 hours. During the first 24 hours are the measurements without medication. After 24 hours the treatment will be started with Gaviscon and will the next 24 hours the measurements under the medication happen. Normally is the medication required after the measurements. With this study the investigators will have multiple measurement points to compare.
详细描述
This is an interventional, with questionnaires. 25 participants will be included.
Parents and children must be willing to have the esophagal pH-monitoring for 48 hours instead of 24 hours.
The restrictions are (like any other esophagal pH-monitoring) :
Do not detach the probe, no bath or shower, no bouncy castle, no swimming pool, ....
Give your child time to get used to the probe. Give your child no carbonated beverages, limit sweets, avoid chewing gum!
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children in whom a pH-monitoring was asked
- •pre school-age children
- •hospitalized children
- •parents have the informed consent signed.
- •Exclusion criteria :
- •children over 6 years
排除标准
- 未提供
研究组 & 干预措施
Gaviscon syrup
Gaviscon will be given to threat patients with reflux after first 24 hours of oesophagal pH-monitoring.
This is a syrup and will be given after every meal. dosage depends from age between 1ml and 5ml after every meal
干预措施: Gaviscon Syrup (Drug)
结局指标
主要结局
Incidence of pathological GERD
时间窗: 24 and 48 hours
change in pathological GERD from baseline at 24 and 48 hours
次要结局
- Effect of Gaviscon on parental concern for parents of infants with GERD(24 hours and 48 hours)
- Effect of Gaviscon on pain in infants with GERD(24 and 48 hours)
研究者
Yvan Vandenplas
Prof. Dr
Universitair Ziekenhuis Brussel