Investigation Into the Dynamic Variations of End-Tidal Carbon Monoxide Concentration (ETCOc) in Neonates Utilizing Non-Dispersive Infrared Spectroscopy and Its Implications for Jaundice Management.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The ETCOc values of newborns were measured, and the optimal ETCOc threshold values between different time points of the TSB group were obtained.
研究概览
简要总结
The objective of this study is to ascertain the diagnostic threshold of end-tidal carbon monoxide (ETCOc, adjusted for ambient CO levels) within the first three days postpartum, stratified by neonatal age at birth. Additionally, the study aims to evaluate the concordance of the risk range of ETCOc, as measured by non-dispersive infrared spectroscopy, with existing literature, and to assess the reliability of this technology in the management of neonatal hyperbilirubinemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 0 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newborns with gestational age of ≥ 37 weeks and birth weight of ≥ 2.5 kg;
- •Newborns delivered by either vaginal delivery or cesarean section and with hospital stay of ≥ 3 days.
排除标准
- •History of second-hand smoke exposure within 24 hours
- •Parents smoke or are exposed to second-hand smoke.
结局指标
主要结局
The ETCOc values of newborns were measured, and the optimal ETCOc threshold values between different time points of the TSB group were obtained.
时间窗: The non-dispersive infrared spectroscopy technique was used to detect ETCOc in newborns at 12 hours, 24 hours, 48 hours and 72 hours after birth (the ETCOc detection should be completed within 4 hours at each time point)
Establish an ETCOc diagnostic threshold for assessing the risk of hyperbilirubinemia in the early postnatal period based on the infant's age at birth. Determine the reliability and repeatability of ETCOc detection using non-dispersive infrared spectroscopy technology.Compare the concentrations of ETCOc between different groups and employ the ROC curve method to ascertain the optimal cut-off values of ETCOc at various time points across the TSB groups.
The ETCOc values of newborns
时间窗: 12 hours, 24 hours, 48 hours and 72 hours after the birth of the newborn
The ETCOc values of newborns were measured, and the optimal ETCOc threshold values between different time points of the TSB group were obtained.
次要结局
未报告次要终点