Neonatal Precursors of Neurodevelopment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Frontal-parietal structural connectivity
研究概览
简要总结
The NEOPRENE project proposes to examine processes that are among the earliest precursors of cognitive functions and assess 1) the relationship between neonatal cognitive precursors and cortical structure, structural connectivity and functional connectivity at birth and 2) the relationship between neonatal cognitive precursors and neurodevelopment.
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
- — 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm newborn (born < 34 weeks + 6days)
排除标准
- •Brain injury
- •Respiratory assistance on measurement day
- •Infection on measurement day
- •Sedation on measurement day
- •Parents < 18 years old or unable to give informed consent
结局指标
主要结局
Frontal-parietal structural connectivity
时间窗: 35 weeks GA
Tractography using Diffusion tensor Imaging in magnetic resonance imaging
Frontal-parietal functional connectivity
时间窗: 35 weeks GA
Synchronization at rest using blood-oxygen level dependent signal in magnetic resonance imaging
Quality of cognitive development
时间窗: 2 years old
Qualitative composite assessment using clinical interview, routine pediatric screening and questionnaires (full sensory profile, preschooler Behavior Rating Inventory of Executive Function)
Electroencephalography evoked response amplitude
时间窗: 35 weeks of gestational age
Electrical field potential changes in the parietal and frontal cortices
Near infrared spectroscopy evoked response amplitude
时间窗: 35 weeks of gestational age
Oxygenated hemoglobin concentration changes in the somatosensory cortex
Grey matter volume in the somatosensory cortex
时间窗: 35 weeks GA
Thickness measured on T2 images in magnetic resonance imaging
次要结局
未报告次要终点