Duration of Esophageal pH-impedance Measurement in Newborns and Infants With Suspected Gastroesophageal Reflux: 12 or 24 Hours?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- bolus exposure index
研究概览
简要总结
To check whether the first 12 hours of MII-pH recording are sufficient to diagnose gastroesophageal reflux disease (GERD) among newborns/infants, with a diagnostic accuracy similar to 24 hours of recording as currently advised.
详细描述
The results of the 24 hour MII-pH recording will be compared to those from the first 12 hour of the same study. To this end the study investigators will select the first 12 hour of the recording using the manufacturer's software (Diversatek Zvu Advanced GI Diagnostic Software). Published normal reference values will be used to confirm gastroesophageal reflux (GER). Appropriate statistical methods will be used to perform calculations. Subgroup analyses based on preterm birth, presence of bronchopulmonary dysplasia and type of prevalent GER symptom (respiratory or gastrointestinal) will be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Day 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •24 hours MII-pH performed for suspected GER
排除标准
- •major malformations
- •previous thoraco-abdominal surgery, gastrostomy, anti-GERD therapy (thickeners, alginates, H2 blockers, proton pump inhibitor - PPIs, etc.) in the 7 days preceding the MII-pH,
- •ventilatory support (invasive or non-invasive) at the time of the MII-pH
结局指标
主要结局
bolus exposure index
时间窗: comparison between the first 12 hours of the test and the whole duration (24 hours)
As detected by manufacturer's software
symptom index
时间窗: comparison between the first 12 hours of the test and the whole duration (24 hours)
As detected by manufacturer's software
symptom association probability
时间窗: comparison between the first 12 hours of the test and the whole duration (24 hours)
As detected by manufacturer's software
number of GER episodes reaching the proximal esophagus
时间窗: comparison between the first 12 hours of the test and the whole duration (24 hours)
As detected by manufacturer's software
time with pH<4
时间窗: comparison between the first 12 hours of the test and the whole duration (24 hours)
As detected by manufacturer's software
number of GER episodes
时间窗: comparison between the first 12 hours of the test and the whole duration (24 hours)
As detected by manufacturer's software
bolus clearance time
时间窗: comparison between the first 12 hours of the test and the whole duration (24 hours)
As detected by manufacturer's software
次要结局
- time with pH<4: subgroup analysis based on gestational age at birth, diagnosis of BPD, prevalent symptoms (respiratory or gastrointestinal)(comparison between the first 12 hours of the test and the whole duration (24 hours))
- symptom association probability: subgroup analysis based on gestational age at birth, diagnosis of BPD, prevalent symptoms (respiratory or gastrointestinal)(comparison between the first 12 hours of the test and the whole duration (24 hours))
- symptom index: subgroup analysis based on gestational age at birth, diagnosis of BPD, prevalent symptoms (respiratory or gastrointestinal)(comparison between the first 12 hours of the test and the whole duration (24 hours))
- number of GER episodes: subgroup analysis based on gestational age at birth, diagnosis of bronchopulmonary dysplasia (BPD), prevalent symptoms (respiratory or gastrointestinal)(comparison between the first 12 hours of the test and the whole duration (24 hours))
- number of GER episodes reaching the proximal esophagus: subgroup analysis based on gestational age at birth, diagnosis of BPD, prevalent symptoms (respiratory or gastrointestinal)(comparison between the first 12 hours of the test and the whole duration (24 hours))
- bolus exposure index: subgroup analysis based on gestational age at birth, diagnosis of BPD, prevalent symptoms (respiratory or gastrointestinal)(comparison between the first 12 hours of the test and the whole duration (24 hours))
- bolus clearance time: subgroup analysis based on gestational age at birth, diagnosis of BPD, prevalent symptoms (respiratory or gastrointestinal)(comparison between the first 12 hours of the test and the whole duration (24 hours))