Observational Study in Preterm Infants With and Without Intracranial Hemorrhage: Longitudinal Assessment of Cerebral Oxygenation, Perfusion and Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Change in cerebral oxygenation
研究概览
简要总结
Intracranial Hemorrhage (ICH) is an important morbidity affecting premature infants and can have considerable effects on neurodevelopmental outcome.
The investigators showed that preterm infants with severe ICH have decreased cerebral oxygenation several weeks after the hemorrhage. The mechanisms involved in this state of decreased cerebral oxygenation in preterm infants and the effects on cerebral function are unknown.
This longitudinal observation study will evaluate physiologic parameters to determine trends in cerebral oxygenation and function in preterm infants with ICH in comparison to infants without ICH.
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
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants born between 23 and 28 weeks of gestation
- •Diagnosed with ICH grades II or higher during the first week after birth
- •Matched control infants without ICH.
排除标准
- •Major congenital malformations
- •Birth asphyxia
- •Not expected to survive
结局指标
主要结局
Change in cerebral oxygenation
时间窗: postnatal weeks 4 and 8
Comparison of the progression of cerebral oxygenation measured non-invasively by near infrared spectroscopy over time in infants with ICH and non-ICH infants.
次要结局
- Change in cerebral perfusion and function(post natal weeks 4 and 8)
研究者
Nelson Claure
Research Associate Professor of Pediatrics
University of Miami