Neonatal Electrical Activity at Different Altitude Levels: A Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 531
- 试验地点
- 2
- 主要终点
- Differences in aEEG indicators in neonates within three days after birth at different altitudes
研究概览
简要总结
In this study, the objective is to compare neonatal cerebral electrical activity within 3 days after birth across different altitude areas using amplitude-integrated electroencephalography (aEEG), and establish reference value for each altitude level.
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
- 0 Hours 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Singleton term infants (gestational age between 37 0/7 and 41 6/7 weeks) born in the participating hospital.
- •Infants appear well as defined by normal vital signs (heart rate ranging from 110 to 180 beats/min, respiratory rate ranging from 30 to 60 breaths/min, temperature ranging from 36.5°C to 37.5°C), absence of signs of illness such as cyanosis, respiratory distress and heart murmur.
- •The mother is permanent residence of the current altitude level and live in the study area for the entire duration of pregnancy.
排除标准
- •Need for supplemental oxygen or assisted ventilation.
- •Any evidence of intrauterine distress such as meconium-stained amniotic fluid, Apgar score <7 at 1 or 5 min.
- •Referred to neonatal intensive care unit or neonatology department for any reason other than observation.
- •With major congenital anomaly.
- •Probes cannot be properly placed due to scalp lesions or hematomas.
- •Reject or withdraw from the study.
结局指标
主要结局
Differences in aEEG indicators in neonates within three days after birth at different altitudes
时间窗: within three days after birth
aEEG data are acquired by aEEG device. This minimum and maximum value is used as the preliminary smoothing value for that specific time point. Next, a three-order low-pass filter is employed to further refine the preliminary values, and a phase compensation algorithm is applied to restore temporal information and obtain smoothed boundaries.For further analyzing the aEEG data, a total of 63 signal features were extracted to reflect the spectral density aspects by the Auto-Neo-EEG pipeline.
次要结局
- Establish reference values for each altitude level(within three days after birth)