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临床试验/NCT02083705
NCT02083705已完成不适用

Chest Compression and Sustained Inflation for Asystole or Bradycardia in Newborn Infants

University of Alberta1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2014年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
1
主要终点
Time Needed to Achieve Return of Spontaneous Circulation

研究概览

简要总结

Guidelines on neonatal resuscitation recommend 90 chest compressions (CC) and 30 manual inflations (3:1) per minute in newborns. The study aimed to determine if CC s during sustained inflations (SI) improves recovery of asphyxiated newborns compared to coordinated 3:1 resuscitation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
— 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Newborn infants with asystole Newborn infants with bradycardia

排除标准

  • 未提供

研究组 & 干预措施

SI+CC

Experimental

Chest compression will be superimposed by sustained inflations during CPR:

"CC+SI group" Infants randomized in the SI group requiring CC, would receive CC at a rate of 90/min during an SI with a duration of 20sec (CC+SI). After 20 sec the SI will be interrupted for 1 sec and the next SI will be started for another 20sec13. Throughout this time CC is continued until ROSC. Every 45 sec (approximately 2 SIs) the clinical team would assess for changes in heart rate. CC+SI was continued until ROSC.

干预措施: CC+SI (Procedure)

3:1 CPR

Active Comparator

CPR using 3:1 C:V ratio:

"3:1 C:V group" Infants randomized into the "3:1 group" requiring CC, would received CC using the current 3:1 C:V ratio recommend in the neonatal resuscitation guidelines16. Every 45 sec the clinical team would assess heart rate. 3:1 C:V CPR was continued until ROSC.

干预措施: 3:1 CPR (Procedure)

结局指标

主要结局

Time Needed to Achieve Return of Spontaneous Circulation

时间窗: within the first 10 minutes after birth

We aim to reduce time needed to achieve Return of Spontaneous Circulation. This should be achieved by the experimental chest compression technique

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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