Use of Near-infrared Spectroscopy in Cerebral Oxygenation Monitoring in Full Term Neonates During Transition After Birth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Cerebral regional oxygen saturation monitoring (crSO2)
研究概览
简要总结
The aim of the study was to assess the values of cerebral oxygenation in full-term neonates in the first 10 minutes of life and to compare these values between neonates delivered by normal vaginal delivery and those delivered by elective cesarean section.
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 Minutes 至 10 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gestational age ≥38 weeks, without any medical support and normal pregnancy development.
排除标准
- •Newborns with gestational age <38 weeks.
- •Newborns with intrauterine growth restriction.
- •Evidence of perinatal depression (hypoxic ischemic encephalopathy).
- •The need for respiratory support or oxygen therapy in the first 10 minutes of life.
- •Suspected or known brain malformations or congenital cyanotic heart disease.
- •Birth complications (e.g. vacuum extraction or forceps application).
- •Newborn delivered through cesarean section with previous attempts of normal vaginal delivery.
结局指标
主要结局
Cerebral regional oxygen saturation monitoring (crSO2)
时间窗: the first 10 minutes of life
Measurements was done by using Near infrared spectroscopy (INVOSTM 5100C Cerebral/ Somatic Oximeter Monitor; Covidien) by placing a neonatal brain sensor on the left frontoparietal area of the newborn's head.
Peripheral oxygen saturation monitoring (SpO2)
时间窗: the first 10 minutes of life
Oxygen saturation was measured using pulse oximeter (Masimo or Nellcor) by applying a preductal pulseoximetry sensor to the right wrist.
Blood gas analysis
时间窗: up to 10 minutes of life
It was performed from umbilical cord blood. All newborns will be clinically observed and evaluated during this period by a neonatologist, and clinical status will be assessed by Apgar score. The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.
Fractional tissue oxygen extraction (FTOE)
时间窗: up to 10 minutes of life
After measuring peripheral oxygen saturation (SpO2) and cerebral regional oxygen saturation (crSO2). For evaluation of the balance of oxygen delivery and oxygen consumption, calculation of the fractional tissue oxygen extraction can be done using the following equation: FTOE=(SpO2-crSO2)/SpO2
次要结局
未报告次要终点
研究者
Marwa Mohamed Farag
Lecturer in Pediatrics, Faculty of Medicine
Alexandria University