Association Between Cardiorespiratory and Gastroesophageal Reflux Events in Infants.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- SAP index
研究概览
简要总结
Cardiorespiratory and gastroesophageal reflux events often coexist in infants in Neonatal Intensive Care Unit (NICU) thus leading to drugs over-prescription and delayed discharge.
Through cardiorespiratory and pH-impedance monitoring this study aims to evaluate the temporal association between gastroesophageal reflux (GER) and cardiorespiratory (CR) events in a large number of infants with gastroesophageal reflux disease (GERD) and CR symptoms and, whether this association is significant, to clarify the impact of GER on CR events.
详细描述
This is an observational retrospective study to describe the association between cardiorespiratory (CR) and gastroesophageal reflux (GER) events in infants who underwent synchronized 24h Multichannel Intraluminal Impedance/pH-metry (MII/pH) and CR monitoring for GER disease symptoms and CR events. Data are collected from medical records and database of the University Neonatal Intensive Care Unit of the Sant'Anna-Regina Margherita Children Hospital (Turin).
The symptom association probability (SAP) index is used to identify those infants with significant associations between GER and CR events. In the group of infants with a positive SAP index the differences in reflux characteristics are compared according to whether a reflux preceded or followed a cardiorespiratory event (30 s time window).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •synchronized MII-pH and cardio-respiratory monitoring lasting more than 12 hours, excluding meal periods;
- •exclusive enteral feeding
- •parents' informed consent
排除标准
- •infectious, genetic, metabolic and neurological diseases
- •ventilatory support and/or oxygen supplementation at the time of MII-pH/CR monitoring
- •pharmacological therapies with effects on GER or apnoea during the week before MII-pH/CR monitoring
结局指标
主要结局
SAP index
时间窗: calculated throughout 24 hours
Symptom Association Probability (SAP) between gastroesophageal reflux and cardio-respiratory events. SAP is considered positive if \> 95%.
次要结局
- Gastroesophageal reflux frequency(calculated throughout 24 hours)
研究者
Francesco Cresi
Principal Investigator
University of Turin, Italy