Assessment of the Cerebral Tissue Oxygenation and the Bioelectrical Brain Activity of Preterm Newborns During Administration of Two Different Surfactant
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Cerebral oxygenation
研究概览
简要总结
The purpose of the study is to determine whether there are differences in bioelectrical function (measured by amplitude integrated electroencephalography) and brain oxygenation (measured by near infrared spectroscopy) while and after instillation of two different surfactant preparations.
详细描述
Patients randomized to one of the treatment groups: 1) SRT with porcine preparation - poractant alfa; 2) SRT with bovine preparation - beractant. Continuous monitoring and simultaneous recordeding of 1) saturation (SpO2) and heart rate (HR) measured with pulse oximetry, cerebral tissue oxygenation measured with near-infrared spectroscopy, amplitude-integrated electroencephalography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Minutes 至 2 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •26-30 gestational age
- •surfactant instillation
排除标准
- •congenital heart disease
- •congenital central nervous disorder
- •congenital genetic disorders
研究组 & 干预措施
Poractant goup
Newborns, who will be monitored by amplitude integrated electroencephalography (aEEG) and near infrared spectroscopy (NIRS) during poractant instillation.
干预措施: Poractant alfa instillation (Drug)
Beractant group
Newborns who will be monitored by aEEG and NIRS during beractant instillation
干预措施: Beractant instillation (Drug)
结局指标
主要结局
Cerebral oxygenation
时间窗: 4 hours after surfactant instillation
Cerebral tissue oxygenation measured with near-infrared spectroscopy
Brain bioelectrical activity
时间窗: 4 hours after surfactant instillation
Brain bioelectrical activity measured with amplitude-integrated electroencephalography (aEEG)
次要结局
未报告次要终点
研究者
Tomasz Szczapa
doctor of medical science
Poznan University of Medical Sciences