Longitudinal Pre-operative Measurements of Cerebral Oxygenation Using Near Infrared Spectroscopy in Neonates With Congenital Heart Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Neurodevelopmental follow up at 24 months
研究概览
简要总结
Congenital heart disease with need for early surgery in newborns is associated with an increased incidence in global impairment in development. The causes of these late adverse neurologic outcomes are multifactoral and include both fixed (or patient-specific factors) and modifiable factors. They relate to both the mechanism of central nervous system injury associated with congenital heart disease and its treatment. Measuring cerebral oxygenation is a promising non-invasive way of cerebral monitoring in a neonatal intensive care unit. The importance of cerebral monitoring in neonates with congenital heart problems at risk of developing neurological complications is increasingly recognized. In this way the most vulnerable moments for the newborn brain can be detected and ,if possible, lead to change in (timing of) treatment.
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
- — 至 1 Month(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •neonates with admission on neonatal intensive care unit with congenital heart disease.
排除标准
- •No informed consent. (for the long term neurodevelopmental FU)
- •no cerebral oxygen saturation in the first 3 day's of life
- •gestational age < 37 weeks
结局指标
主要结局
Neurodevelopmental follow up at 24 months
时间窗: 24 months
Neurodevelopmental assessment at 24 months using Bayley scales of infant development II
次要结局
- Association of cerebrovascular changes with short term outcome(time frame of 1 admission)
- cerebrovascular changes in the transitional phase(first 3 days of life)
