Evaluation of Cerebral, Hemodynamic and Neuronal Activities in Neonates in the Immediate Postpartum
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- time-frequency correlation with EEG
研究概览
简要总结
Neonatal anoxia-ischemia causes significant neurodevelopmental disorders. In this study the investigators want to better understand the interactions between the nervous and the hemodynamic cerebral systems during the adaptation of the neonate to ectopic life just after birth. Birth is an at risk situation of neonatal anoxic ischemia and the lack of objective criteria for cerebral tissue oxygenation has consequences on neuronal activity. Ph cord analysis is inadequate and only indirectly reflects the state of cerebral oxygenation. Both neuronal and vascular systems are part of the same functional entity and the analysis of their interactions is likely to reveal some early malfunctions of these networks.
In this study, the investigators want to develop a multi-scale, multimodal approach that allows simultaneous interrogation of both neuronal and vascular compartments during the 15 minutes after delivery. The investigators will record, with the aid of a single sensor placed on the scalp of the child, the electroencephalogram and the cerebral tissue oxygenation. The investigators will measure interactions by means of correlation analysis between both signals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 1 Minute 至 15 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Full term neonates between 36 and 41 weeks Gestational Age
排除标准
- •Premature neonates
- •Neonates of twin pregnancy
- •Suspicion of congenital malformation seen in antenatal ultrasound
- •Any pathology requiring pediatric care from birth
- •Newborns whose mothers had a chronic viral infection such as AIDS, hepatitis B or C, or who had a multidrug-resistant bacteria
结局指标
主要结局
time-frequency correlation with EEG
时间窗: within the 5 minutes after birth
Within the 5 min after birth the electroencephalogram and the cerebral oxymetry of the neonates will be recorded with the aid of a patch on the scalp. A multimodal approach must be developed to interrogate the dynamics and interactions of neuronal and vascular compartments, which constitute a single functional unit.
temporal correlation with NIRS signals
时间窗: within the 5 minutes after birth
Within the 5 min after birth the electroencephalogram and the cerebral oxymetry of the neonates will be recorded with the aid of a patch on the scalp. A multimodal approach must be developed to interrogate the dynamics and interactions of neuronal and vascular compartments, which constitute a single functional unit.
time-frequency correlation with NIRS signals
时间窗: within the 5 minutes after birth
Within the 5 min after birth the electroencephalogram and the cerebral oxymetry of the neonates will be recorded with the aid of a patch on the scalp. A multimodal approach must be developed to interrogate the dynamics and interactions of neuronal and vascular compartments, which constitute a single functional unit.
Temporal correlation with EEG
时间窗: within the 5 minutes after birth
Within the 5 min after birth the electroencephalogram and the cerebral oxymetry of the neonates will be recorded with the aid of a patch on the scalp. A multimodal approach must be developed to interrogate the dynamics and interactions of neuronal and vascular compartments, which constitute a single functional unit.
次要结局
- Mode of delivery correlation with temporal and EEG data(within the 5 minutes after birth)