Effect of Supine or Prone Position at Delivery on Respiratory Outcomes in Full-Term Infants Following Elective Caesarean Birth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
研究概览
简要总结
Respiratory Distress is a frequent clinical diagnosis of babies delivered by elective Caesarean birth. There has been no study comparing the efficacy of immediately positioning a newly born infant prone vs. supine for the first 30 60 seconds of life after delivery by Caesarean birth.
详细描述
This study hypothesizes that when the infant is prone they will have postural drainage, better dorsal lung expansion, less vagal response from suctioning and less agitation secondary to the righting reflex.
This study will compare 1033 term babies divided by randomization into two groups prone and supine. During the study, care givers will monitor and record incidence and severity of Respiratory Distress, Use of FiO2 or respiratory support, admissions to NICU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •* Any woman not in labor who are undergoing elective Cesarean birth at term, 37 to 41 completed weeks gestation.
排除标准
- •any woman with prior rupture of membranes
- •diabetes mellitus, gestational diabetes,
- •any woman receiving sedation
- •using medication such as Demerol, magnesium sulfate or general anesthesia
- •any woman who has a known drug history
- •any known macrosomia
- •known congenital anomalies or meconium stained fluid
- •any woman with illnesses such as maternal fever, chorioamnionitis, severe neonatal distress
- •any woman with compromised infant at delivery
- •oligohydramnios
- •history of antenatal steroids.
研究组 & 干预措施
Prone Positioning
Newly born infant placed in prone position (face up) for the first 30 60 seconds of life after delivery by Cesarean birth.
干预措施: prone positioning (Procedure)
Supine Positioning
newly born infant placed in supine position (face down) for the first 30 60 seconds of life after delivery by Cesarean birth.
干预措施: Supine (Procedure)
研究者
Orna Rosen
Asst Prof., Dept of Pediatrics (Neonatology)
Montefiore Medical Center