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临床试验/NCT00817310
NCT00817310已完成不适用

Influence of Altered Cerebral Spinal Fluid and Arterial Flows on Cerebral Processing Functions in Premature Infants With Severe Intraventricular Hemorrhage

Vanderbilt University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009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
60
试验地点
1
主要终点
neurodevelopmental outcome

研究概览

简要总结

Currently, when premature infants develop severe intraventricular hemorrhage (IVH), a type of intracerebral bleed, there are no proven therapeutic interventions to prevent the devastating consequences of this event. These children will be likely to develop cerebral palsy or severe cognitive delays.

The purpose of our study is to characterize differences in brain physiology, imaging, and function between premature infants with severe IVH and controls. The goals for gathering this information are to generate baseline data, which could facilitate early screening for complications of IVH in premature infants. These baseline data would also allow the design and implementation of early therapeutic interventions to help rehabilitate premature infants with severe IVH.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
— 至 14 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Birth weight < 1500 grams for all inborn infants and age less than 14 post-natal days
  • Birth weight < 1500 grams for all outborn infants transferred to the VCH NICU within the first 72 hours after birth and age less than 14 post-natal days
  • Parents agree to their infant's participation and give informed written consent.

排除标准

  • Unable to obtain informed consent.
  • Congenital brain malformations leading to hydrocephalus
  • Genetic and metabolic disorders leading to cerebral pathology

结局指标

主要结局

neurodevelopmental outcome

时间窗: 3 years

BSID III scores

次要结局

未报告次要终点

研究者

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

Nathalie Maitre

Assistant Professor

Vanderbilt University

研究点 (1)

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