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临床试验/NCT01942525
NCT01942525Unknown不适用

Intrauterine Growth Restriction Has an Impact on Amplitude-integrated EEG in Preterm Infants

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2010年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
156
试验地点
1
主要终点
aEEG score (including background pattern, occurrence of sleep-wake-cycling and presence of seizure activity)

研究概览

简要总结

Objective: The impact of intrauterine growth restriction (IUGR) on perinatal morbidity and long-term neurodevelopmental outcome has been published in numerous studies. Throughout this analysis, the influence of IUGR on the postnatal amplitude-integrated EEG (aEEG) in preterm infants below 30 weeks of gestation was assessed. The second concern was the correlation between the pattern of the aEEG in the first two weeks with neurodevelopmental outcome, comparing infants with and without IUGR.

Methods: Routinely assessed aEEG data of preterm infants with IUGR born below 30 weeks of gestation in the years 2005 until 2007 were analysed retrospectively according to the aEEG score (combining occurrence of sleep-wake-cycles, background activity and suspected seizure activity). Neurodevelopmental outcome was evaluated at 24 months using the Bayley Scales of Infant Development and standardized neurologic examination.

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
23 Weeks 至 30 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • preterm infants below 30 weeks of gestation

排除标准

  • congenital anomalies
  • severe asphyxia

结局指标

主要结局

aEEG score (including background pattern, occurrence of sleep-wake-cycling and presence of seizure activity)

时间窗: first 14 days of life

composite score background activity (BA), occurrence of sleep-wake-cycling (SWC) and presence of seizure activity (SA) meaning score 1= normal (normal BA, SWC yes, SA no) and score 2 and 3 = abnormal (2=abnormality in 1 category (BA, SWC or SA) and score 3= abnormality in 2 or 3 categories

次要结局

  • Neurodevelopmental outcome(24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Katrin Klebermass-Schrehof

MD

Medical University of Vienna

研究点 (1)

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