Influence of Altered Cerebral Spinal Fluid and Arterial Flows on Cerebral Processing Functions in Premature Infants With Severe Intraventricular Hemorrhage
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
- 否
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
Nathalie Maitre
Assistant Professor
Vanderbilt University
