高海拔地区健康足月新生儿脑氧代谢及脑电活动差异的多中心临床研究方案

Cerebral oxygen metabolism and brain electrical activity of healthy full-term neonates in high-altitude areas: a multicenter clinical research protocol

摘要:

高原环境对新生儿神经功能的影响仍需进一步证据积累。通过无创脑近红外光谱技术和振幅整合脑电图检测技术可提供脑氧饱和度及脑电活动数据。该研究通过对不同海拔梯度健康足月新生儿生后3 d内不同时间点进行多次近红外光谱技术、振幅整合脑电图监测，将测得的脑氧饱和度、脑电活动数据在不同海拔间进行比较，并建立相应的参考值范围。该研究包括6家中国高原新生儿医学联盟参与单位，根据所在地海拔分为4个海拔梯度，分别是800 m、1 900 m、2 400 m和3 500 m，每个海拔梯度预计样本量170人。该多中心前瞻性队列研究将为高原环境对新生儿早期脑功能及代谢的影响提供证据支持。

Abstract:

Further evidence is needed to explore the impact of high-altitude environments on the neurologic function of neonates. Non-invasive techniques such as cerebral near-infrared spectroscopy and amplitude-integrated electroencephalography can provide data on cerebral oxygenation and brain electrical activity. This study will conduct multiple cerebral near-infrared spectroscopy and amplitude-integrated electroencephalography monitoring sessions at various time points within the first 3 days postpartum for healthy full-term neonates at different altitudes. The obtained data on cerebral oxygenation and brain electrical activity will be compared between different altitudes, and corresponding reference ranges will be established. The study involves 6 participating centers in the Chinese High Altitude Neonatal Medicine Alliance, with altitude gradients divided into 4 categories: 800 m, 1 900 m, 2 400 m, and 3 500 m, with an anticipated sample size of 170 neonates per altitude gradient. This multicenter prospective cohort study aims to provide evidence supporting the impact of high-altitude environments on early brain function and metabolism in neonates.