Supine vs Prone Position During Delayed Cord Clamping in Term Infants A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Hemoglobin and hematocrit
研究概览
简要总结
This study is conducted to evaluate if the prone position of the newborn on the chest of his mother at birth before delayed cord clamping leads to better hematocrit and hemoglobin at 24-48 hours of life compared to supine position.
详细描述
At 30 hours of life, laboratory personnel drew a capillary sample from the infant's heel for hemoglobin, hematocrit, and total serum bilirubin at the same time as the newborn metabolic screening sample. There is no added heelstick to routine care, as current standard in our institution requires the bilirubin to be drawn at 30 hours of life.
During universal screening for congenital cardiac defects (30 hours of life), a value of cerebral saturation (CrSO2) is measured using NIRS with INVOS (In Vivo Optical Spectroscopy, INVOS System, Covidien, Dublin, Ireland, Somanetics). Sensors are placed over the forehead and the newborn is in supine position.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Minute 至 2 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newborn ≥ 36 weeks gestational age and Born vaginally and Well appearing
排除标准
- •Out born infant, Infant born by caesarian section, Preterm born less than 36 weeks GA, Infant with intra uterine growth restriction (IUGR: less than 10th percentile) Asphyxiated infant Infant needing immediate resuscitation, Newborn with malformation (gastroschisis, omphalocele, anal atresia, severe head skin injury, congenital cardiac disease Newborn with mother with preeclampsia or gestational hypertension or diabetes on insuline or hemolytic disease or on chemotherapy or on cortisone.
结局指标
主要结局
Hemoglobin and hematocrit
时间窗: 24-48 hours
Hemoglobin value
次要结局
- Cerebral saturation by near infrared spectroscopy (NIRS)(24-48 H of life)
- Bilirubin(24-48 hours)
研究者
Dr Brahim Bensouda
MD
Maisonneuve-Rosemont Hospital