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临床试验/NCT01197807
NCT01197807已完成不适用

Newborn Resuscitation: A Randomized Controlled Trial of Oronasopharyngeal Suction Versus Simple Nose and Mouth Wiping in Term Newborns

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 506 人开始时间: 2010年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
506
试验地点
2
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

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

John Kelleher, MD

Fellow Instructor, Department of Pediatrics, Division of Neonatology

University of Alabama at Birmingham

研究点 (2)

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