跳至主要内容
临床试验/NCT00728234
NCT00728234已完成不适用

Analysis of Amplitude-Integrated Electroencephalography and Its Predictive Value for Neurodevelopmental Outcome in Preterm Infants Born Below 30 Weeks Gestational Age

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 284 人开始时间: 2000年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
284
试验地点
1
主要终点
amplitude-integrated electroencephalography tracings of the first weeks of life; obtained on a weekly basis

研究概览

简要总结

The study included analysis of longitudinal recordings of amplitude-integrated EEG (aEEG) tracings on a weekly basis in preterm infants and evaluation of their neurodevelopmental outcome at the age of three years.

Aim of the study was to observe if there is a correlation of the aEEG tracings of the first weeks of life to later neurodevelopmental outcome and to evaluate if aEEG can be used as prognostic tool.

详细描述

From the first week of life on aEEG-recordings were obtained on a weekly basis and the results of the first eight weeks of life were analyzed for this study.

aEEG-tracings were analyzed with regard to background activity (percentages of continuous and discontinuous patterns), the presence/absence of sleep-wake-cycles and the occurrence of seizure activity. These items where summed up in a score including three grades (normal, moderately and severely abnormal).

The aEEG was recorded as a single channel EEG from biparietal surface disk electrodes using a CFM (CFM 5330, Lectromed Devices Ltd., UK) or the CFM 6000 (Olympic Medical, USA). Assessment of neurodevelopmental outcome was done at three years of age by assessment of the Bayley Scales of Infant Development II (BSID-II) During the study period from January 1st 2000, and December 31st 2002 a total of 284 preterm infants less than 30 weeks´ gestational age were admitted to the neonatal intensive care unit of the Medical University of Vienna. Neurodevelopmental outcome could be obtained in 148/284 infants at the age of three years and these infants therefore fulfilled the inclusion criteria for this study

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
23 Weeks 至 29 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • gestational age < 30 weeks

排除标准

  • brain malformation
  • inborn error of metabolism

结局指标

主要结局

amplitude-integrated electroencephalography tracings of the first weeks of life; obtained on a weekly basis

时间窗: 8-12 weeks

次要结局

  • neurodevelopmental outcome at the age of three years assessed by Bayley Scales of Infant Development(three years)

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验