Oxygenation of the Neonatal Brain - a Study Using the INVOS Oximeter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Changes from baseline of cerebral oxygen saturation after oxygen exposure.
研究概览
简要总结
- Due to the increased risk of brain damage, continuous monitoring of the cerebral oxygenation is interesting. The investigators will evaluate the capability of the INVOS Oximeter to detect induced changes in the cerebral regional saturation.
- The purpose of the study is to investigate our hypothesis that cerebral vasoconstriction after oxygen exposure is prolonged in preterm infants compared to term infants.
详细描述
Preterm infants are at increased risk of brain damage compared with term infants, and cerebral hypoxia is considered to have an important role. The preterm infants are at increased risk of respiratory distress, episodes with low oxygenation, mechanical ventilation, risk of hypocapnia and labile or low blood pressure. These conditions can affect the microcirculation and hence the oxygenation of the brain. Hyperoxia is also a point of interest, since high levels of oxygen can cause vasoconstriction.
The investigators will examine the normal physiological cerebral response to exposure of oxygen in a group of preterm infants with a gestational age (GA) of 32-37 weeks and a group of term infants.
The investigators will do dynamic research with continuously monitoring of the cerebral oxygenation using the INVOS® Cerebral/Somatic Oximeter (Near InfraRed Spectroscopy (NIRS)). Reproducibility is examined by repeated measurements.
There will be no follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 1 Hour 至 4 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns with a gestational age of 32-40 weeks
- •Clinically stable
- •+/- CPAP with a oxygen limit below 30%
- •Parental consent
排除标准
- •Severe birth asphyxia
- •Prohibition of oxygen exposure
研究组 & 干预措施
Oxygen + Cerebral NIRS
Induced changes in oxygen supply (100% vs. room air). Continuously monitoring of cerebral oxygen saturation.
干预措施: Oxygen (Drug)
结局指标
主要结局
Changes from baseline of cerebral oxygen saturation after oxygen exposure.
时间窗: Measurements will take between 30 minutes and 3 hours depending of situation. Measurements within the first 4 weeks of life. No follow-up.
次要结局
未报告次要终点
研究者
Line Carøe Sørensen
MD, PH.D.
Copenhagen University Hospital, Hvidovre