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临床试验/NCT03902652
NCT03902652撤回不适用

Does Higher (100% Oxygen) Versus Lower (21% Oxygen) During Sustained Inflation and Chest Compression During Cardiopulmonary Resuscitation of Asphyxiated Newborns Improve Time to Return of Spontaneous Circulation - a Randomized Control Trial

University of Alberta1 个研究点 分布在 1 个国家开始时间: 2022年8月27日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Return of spontaneous Circulation

研究概览

简要总结

When newborn babies are born without a heartbeat the clinical team has to provide breathing and chest compressions (what is call cardiopulmonary resuscitation) to the newborn baby. Cardiopulmonary resuscitation is an infrequent event in newborn babies (~1% of all deliveries), approximately one million newborn babies die annually due to lack of oxygen at birth causing being born without a heartbeat. Outcome studies of newborn babies receiving cardiopulmonary resuscitation in the delivery room have reported high rates of death and neurological impairment. This puts a heavy burden on health resources since these infants require frequent hospital re-admission and long-term care.

The poor prognosis raises questions as improve cardiopulmonary resuscitation methods and specifically adapt them to newborn babies to improve outcomes. Currently a 3:1 ratio, which equals 3 chest compressions to one rescue breath to resuscitate a newborn baby. This means that chest compressions are stopped after every 3rd compression to give one rescue breath. The investigators believe that this interruption of chest compressions is bad for the newborn baby and that chest compressions should be continued without interruption while rescue breaths are given continuously. The investigators believe that this approach will allow us to reduce death and long-term burdens in newborn babies born without a heartbeat.

Furthermore, it is not known if rescue breaths given with 100% oxygen or 21% oxygen (room air) is better for newborn babies.

Using continuous chest compressions and rescue breaths without interruptions, this study will compare 21% with 100% oxygen.

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
Single (Outcomes Assessor)

入排标准

年龄范围
0 Minutes 至 20 Minutes(Child)
性别
All
接受健康志愿者

入选标准

  • Term infants requiring chest compressions in the delivery room
  • Preterm infants >28 weeks' gestation requiring chest compressions in the delivery room

排除标准

  • Infants with congenital abnormality
  • Infants with congenital diaphragmatic hernia or congenital heart disease
  • Infants who's parents refused to give consent to this study

结局指标

主要结局

Return of spontaneous Circulation

时间窗: up to 60 Minutes of chest compression

Duration of chest compression heart rate is \>60/min for 60sec.

次要结局

  • Mortality(Until infant is discharge from hospital (maximum of 30 weeks after birth))
  • Number of Epinephrine dosses during resuscitation(During resuscitation (up to 60 minutes))
  • Rate of brain injury(Until infant is discharge from hospital (maximum of 30 weeks after birth))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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