A Prospective Study on Establishing the Reference Interval for Pulse Oxygen Saturation in Neonates at High Altitude
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Pulse oxygen saturation of healthy neonates at high altitude.
研究概览
简要总结
The now widely used reference interval for pulse oxygen saturation of the neonate after 24 hours of birth has been developed relying on data from low altitude.It is not suitable for neonates at high altitude. At present, no reference interval has been established at high altitude, and the existing studies have many limitations. So this study was designed.
详细描述
Knowledge of the reference interval of pulse oxygen saturation (SpO2) in neonates is crucial for accurate identification of neonatal hypoxemia. The now widely used standard was derived from low altitude data, which is not suitable neonates at high altitude. At present, many scholars have paid attention to this problem. But, previous studies still have some limitations. For example, they often only focus on a specific altitude. However, with the increase of altitude, the pulse oxygen saturation decreases in a curve, so their study results are only suitable for this specific altitude and can not be widely used.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 24 Hours 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy singleton term infants with no clinical signs and symptoms (e.g., cyanosis, respiratory distress, heart murmur, etc.).
排除标准
- •Low birth weight (< 2500 g).
- •Need for oxygen. 3.1 or 5 minute Apgar score <
- •Referred to the neonatal intensive care unit or neonatology department for various reasons.
- •Neonates discharged within 24 hours of birth.
- •Neonates diagnosed with congenital diseases in utero.
- •Refusal of consent.
结局指标
主要结局
Pulse oxygen saturation of healthy neonates at high altitude.
时间窗: 24 hours after birth
Pulse oxygen saturation of the right hand and any foot of healthy neonates born at high altitude will be measured 24 hours after birth. According to the normality of the results, the distribution range will be described by mean ± standard deviation or range interquartile. Altitude level: ≥ 2000m.
次要结局
未报告次要终点
研究者
Zhangbin Yu
Clinical Professor，Shenzhen People's Hospital
The Second Clinical Medical College of Jinan University