Time to Accurate Heart Rate on Neonatal Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Time to Heart Rate Display in iRes Warmer With Resusview
研究概览
简要总结
The goal of this trial is to compare the time to first heart rate displayed for iRes Warmer with ResusView and using iRes Warmer without ResusView when used in the resuscitation (e.g. Cardiopulmonary resuscitation or breathing assistance) of premature newborns (23 to 32+6 weeks gestation).
详细描述
This is a prospective interventional randomized control trial. Infants born between 23+0 and 32+6 estimated gestational age will be randomized using a computer generate allocation sequence stratified by gestational age. Randomization cards will be placed in opaque envelopes. For the intervention group, the care team will use the Panda iRes Warmer with ResusView Bed during resuscitation interventions in the first 10 minutes of life. During use of the iRes-warmer, standard nursing care of an infant on a radiant warmer will be followed. Participants assigned to the control group will receive interventions using the same model Panda bed without ResusView. There is no minimum time for monitoring, and the maximum time depends on clinical determination for use of heart rate feature for each resuscitation event. Data including the infant's gestational age, Electrocardiogram lead type and activities that occurred during resuscitation will be recorded for the first 10 minutes of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 23 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants who are delivered to mothers over the age of 16 years of age
- •Infants delivered at 23+0 to 32+6 weeks estimated gestational age based on the best obstetric estimate at the time of delivery.
- •Infants without known congenital malformations prior to delivery
- •Antenatal consent
排除标准
- •Infants who are delivered to mothers under the age of 16 years of age
- •Known congenital anomalies of newborn prior to delivery
- •Cardiac defects other than small Ventricular septum defect and Patent ductus arteriosus
- •Multiples
- •Declined consent
- •iRes Warmer with ResusView not available at time of delivery
结局指标
主要结局
Time to Heart Rate Display in iRes Warmer With Resusview
时间窗: Birth to 10 minutes of life
Measure time from birth to heart rate displayed on monitor following lead placement
次要结局
- Time to Initiation of Positive Pressure Ventilation (PPV)(Birth to 10 minutes of life)
- Time to First Change in Fraction of Inspired Oxygen(Birth to 10 minutes of life)
- Time to First Change in Airway Pressure(Birth to 10 minutes of life)