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临床试验/NCT00516334
NCT00516334Unknown不适用

Advanced Electrophysiological Studies of the Premature Newborn Infant Brain: Understanding Brain Injury

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2006年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1

研究概览

简要总结

This study is evaluating whether a bedside brainwave monitor can be used to detect early brain injury in premature infants.

详细描述

Patient enrollment and electroencephalographic (EEG) and clinical data collection stopped May 2009. Data analysis is ongoing, and results have been described (O'Reilly D, Navakatikyan MA, Filip M, Greene D, Van Marter LJ. Peak to Peak Amplitude in Neonatal Brain Monitoring of Premature Infants. Clin Neurophysiol 2012 May 16), via publication in a peer-reviewed journal. Another manuscript has been completed and is undergoing revision for resubmission. We anticipate several additional articles will be completed from the data collected during this study. There is no relationship between industry and no current funding for this study. We maintain institutional review board approval due to ongoing data analysis.

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
1 Day 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infants inborn below 28 weeks gestation

排除标准

  • At birth, deemed not likely to survive 7 days or more
  • Major intracranial congenital anomaly

研究者

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

Linda J. Van Marter, M.D., M.P.H.

Attending Neonatologist and Associate Professor of Pediatrics Harvard Medical School

Brigham and Women's Hospital

研究点 (1)

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