Newborn Resuscitation: A Randomized Controlled Trial of Oronasopharyngeal Suction Versus Simple Nose and Mouth Wiping in Term Newborns
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 506
- 试验地点
- 1
- 主要终点
- Mean respiratory rate over the first 24 hours of life
研究概览
简要总结
Until recently, bulb or catheter oronasopharyngeal suctioning (ONPS) of all the infants, including vigorous infants in the delivery room, has been featured as a standard of newborn care. The 5th edition of the Newborn Resuscitation Program (NRP) has minimized the recommendation for routine suctioning of infants following delivery, provided they are not depressed or in need of immediate resuscitation. However, this new alternative recommendation was based on a small randomized trial and other lower level evidence rather than evidence from larger trials. The NRP Textbook cautions against vigorous suctioning because of the resultant apnea or bradycardia. Furthermore, suctioning may delay other more important steps of resuscitation. Thus, it is necessary to compare the alternative recommended practice, i.e. simple wiping of the mouth, to determine if it has equivalent efficacy and a favorable side effect profile compared to suctioning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Minute 至 1 Minute（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inborn neonates at the UAB hospital with gestational age greater than or equal to 35 weeks.
排除标准
- •Major birth anomalies or where a decision to institute comfort care only has been made antenatally
- •Significant resuscitation efforts are anticipated prior to delivery
- •Nonvigorous infants with meconium stained amniotic fluid
研究组 & 干预措施
Bulb suctioning
Bulb suctioning of mouth and nose immediately after delivery
干预措施: Bulb Suctioning (Procedure)
Wiping
Gentle wiping of mouth then nose with soft cloth
干预措施: Wiping (Procedure)
结局指标
主要结局
Mean respiratory rate over the first 24 hours of life
时间窗: 24 hours after birth
Respiratory rates measured every 8 hours during the first 24 hours after birth
次要结局
- Apgar Scores at one minute of age(1 minute of age)
- Number of newborns with tachypnea(24 hours)
- Need for delivery room resuscitation(1 hour after birth)
- Admission to the Neonatal Intensive Care Unit(1 hour after birth)
- Oxygen saturations prior to discharge from hospital(5 days of age)
- Apgar score at 5 minutes of age(5 minutes of age)
研究者
John Kelleher, MD
Fellow Instructor, Department of Pediatrics, Division of Neonatology
University of Alabama at Birmingham