NCT04303494已完成不适用
Predictive Value of Heart Rate Variability on Cardiorespiratory Events of Preterm Infants Routinely Immunised in the Hospital
University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 292 人开始时间: 2018年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 292
- 试验地点
- 1
- 主要终点
- Changes in AOP
研究概览
简要总结
The aim of this study are to investigate whether heart rate variability (HRV) parameters derived from nonlinear time series analysis at five different time points have prognostic utility for assessing the risk of postimmunisation AOP in very preterm/very low birth weight infants immunised in the hospital.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Major congenital malformations including neuromuscular disorders, thoracic malformations, major cardiac malformation
- •Lack of written informed parental consent
结局指标
主要结局
Changes in AOP
时间窗: record the sum of AOP events from 48 hours windows of raw data, within 24 hours after - 24 hours before immunisation
Difference in AOP events within 24 hours after - 24 hours before immunisation
次要结局
- Difference in number of manual stimulations(number of manual stimulations within 24 hours after - 24 hours before immunisation)
- Difference in number increases in oxygen concentration(record oxygen concentration from 48 hours windows of raw data, within 24 hours after - 24 hours before immunisation)
- Difference in number of increases in continuous positive airway pressure (CPAP)(within 24 hours after - 24 hours before immunisation)
- Difference in sample entropy (SampEn) of interbeat interval of heart rate (IBI)(24 hours after - immediately prior to immunisation)
- Difference in number of endotracheal intubation(within 24 hours after - 24 hours before immunisation)
- Difference in number of reinstallations in continuous positive airway pressure (CPAP)(within 24 hours after - 24 hours before immunisation)
- Difference in prolonged hypoxaemic episodes(record SpO2 from 48 hours windows of raw data, within 24 hours after - 24 hours before immunisation)
- Difference in SampEn of IBI(preterm infants measured at 37 to 42 weeks)
研究者
研究点 (1)
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