The Neu-Prem Trial: Neuromonitoring of Preterm Newborn Brain During Birth Resuscitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- EEG
研究概览
简要总结
The purpose of this study is to characterize the normal brain function of premature infants (23 to 31+6 weeks GA) during birth transition and through the first 72 hours of life.
详细描述
The investigators will measure components of brain function using two sophisticated, non-invasive technologies. First, amplitude integrated electroencephalography (EEG), a "simplified" EEG with four sensors (single channel), enables continuous non-invasive monitoring of cerebral activity. Second, near-infrared spectroscopy (NIRS) is another non-invasive technology that allows continuous real-time measurement of regional tissue oxygen utilization of the brain. Both technologies have been used in newborns and have been predictive of brain injury or neurodevelopmental impairment.
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 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •23 to 31+6 weeks gestational age at birth
排除标准
- •Known congenital anomalies
- •Parents refuse consent
- •Neonatologist declined due to subject instability
结局指标
主要结局
EEG
时间窗: Birth to 72 hours of life
amplitude integrated EEG to measure brain activity
NIRS
时间窗: Birth to 72 hours of life
Cerebral tissue oxygen saturation (StO2), Near-infrared spectroscopy to measure brain perfusion
次要结局
- Maximum FiO2(From birth to 10 minutes of life)
- Heart rate(Birth to 72 hours of life)
- Cardiac output(From neonatal intensive care unit (NICU) admission through 72 hours of life)
- Head Ultrasound(Within 24 hours of life and at approximately 72 hours of life)
- MRI(From birth through discharge to home, up to 9 months of age)
- Neurodevelopmental impairment at 2 year follow up(18 to 30 months corrected gestational age)
- Apgar scores(1, 5 and 10 minutes of life if applicable)
- Cord gases(Upon delivery)
- Resuscitation intervention(From birth to 10 minutes of life)
- Maximum peak inspiratory pressure(From birth to 10 minutes of life)
- Heart rate by EKG during resuscitation (substudy)(Birth)
- Mean arterial blood pressure(From NICU admission through 72 hours of life)
- Use of cardiac inotropes(From birth through discharge to home, up to 9 months of age)
研究者
Anup Katheria, M.D.
Director of Neonatal Research
Sharp HealthCare