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临床试验/NCT05760274
NCT05760274已完成不适用

Duration of Esophageal pH-impedance Measurement in Newborns and Infants With Suspected Gastroesophageal Reflux: 12 or 24 Hours?

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2022年7月13日最近更新:
适应症

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

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))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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