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临床试验/NCT00950287
NCT00950287已完成不适用

Early Detection of Severe Apnea-bradycardia in Preterm Infants Using Algorithm Fusion

Rennes University Hospital3 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2009年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
54
试验地点
3
主要终点
Number of false positive alarm detections

研究概览

简要总结

Apnea-bradycardia is a frequent phenomenon in preterm infants which has been associated with short term complications and alterations in neurodevelopment. Duration and amplitude of the bradycardias depend on the time delay between the beginning of the bradycardia and the intervention of the nurse.

The purpose of the study is to test a new method set for early detection of bradycardia in preterm infants.

详细描述

Apnea-bradycardia is a frequent phenomenon in preterm infants which has been associated with short term complications and alterations in neurodevelopment. Duration and amplitude of the bradycardias depend on the time delay between the beginning of the bradycardia and the intervention of the nurse.

The purpose of the study is to test in clinical units and in real life a new method set for early detection of bradycardia in preterm infants.

Each preterm infant cardio-respiratory traces will be recorded during two 4-hours periods of time (the first one at the time of occurrence of apnea-bradycardias and the second one during the following week). During those periods, the alarms of the monitors usually used in the units will also be recorded through automatic detection and these alarms will be compared with the alarms generated by the algorithm tested, for false positive and precocity of the detection. A false positive alarm is a detection which is not associated with a bradycardia of less than 80 bpm. The system will be considered efficient if it allows an earlier detection of severe bradycardias without increasing the number of false positive detection.

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
4 Days 至 33 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Parents informed consent
  • Presenting with at least 2 significant apnea bradycardia (apnea + decrease in heart rate of more than 33% during at least 4 sec)

排除标准

  • Postnatal age of less than 4 days
  • Mechanical ventilation
  • Severe neurological lesion

结局指标

主要结局

Number of false positive alarm detections

时间窗: 1 week

次要结局

  • Delay between the beginning of the bradycardia and the detection. Sensitivity, specificity, positive predictive value, negative predictive value(1 week)

研究者

发起方
Rennes University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (3)

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