Vasopressin vs. Epinephrine During Neonatal Cardiopulmonary Resuscitation - a Cluster Randomized Controlled Phase I Trial
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Time to ROSC (Return of spontaneous Circulation)
研究概览
简要总结
When a baby is born with a low heart rate or no heart rate, the clinical team must provide breathing support and chest compressions (what is call cardiopulmonary resuscitation or CPR). In some situations, the clinical team also need to give medications to help the heart rate increase. During CPR, the most common medication given is called epinephrine. There is another medication called vasopressin that is available that could be beneficial to newborn babies. However, no study has compared epinephrine with vasopressin in the delivery room during neonatal CPR.
The current study will be the first trial comparing this two medications during neonatal CPR.
The investigators will randomize our hospital to either epinephrine or vasopressin for the duration of one year. Babies will either receive CPR with epinephrine (this will be the control group) or CPR with vasopressin ( this will be the intervention group). The investigators believe that vasopressin may be more helpful to babies with a low heartrate or no heart rate at birth.
详细描述
Purpose
The infrequent need for CC and epinephrine during neonatal resuscitation, coupled with an inability to consistently anticipate which newborn infants are at high risk of requiring extensive CPR, explains the ongoing lack of high quality evidence (i.e., large randomized clinical trials) to better guide healthcare providers in their resuscitative effort. Guidelines for neonatal resuscitation recognized the lack of neonatal data and extrapolate data from studies with adults and adult/pediatric animal studies. Those data may not apply wholly to the neonatal population. Therefore, neonatal data are needed to determine the optimal vasopressor therapy during neonatal resuscitation.
Hypothesis
In newborns who require CPR does Vasopressin compared to Epinephrine reduce time to achieve return of spontaneous circulation defined as a heart rate of >60/min for 60sec .
Justification
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- 否
入选标准
- •Infants (term or preterm infants) born without heart beat or with bradycardia
排除标准
- •Congenital heart disease (e.g., hypo-plastic left heart) Condition that have adverse effect on breathing or ventilation (e.g., congenital diaphragmatic hernia), o
研究组 & 干预措施
Vasopressin
"Vasopressin group" Vasopressin will be via umbilical vein catheter (0.4 IU/kg per dose - first line) or alternatively via an endotracheal tube (8 IU/kg) every three to five minutes as needed with a maximum of two doses if there is no ROSC [2,3] After that, the clinical team must convert to give epinephrine (0.02 mg/kg per dose) as long as CPR is ongoing.
干预措施: Vasopressin (Drug)
Epinephrine
Epinephrine group" Epinephrine will be administered according to current resuscitation guidelines either via umbilical vein catheter (0.02 mg/kg per dose) or via endotracheal tube (0.1 mg/kg) every three to five minutes as needed[2,3]. Chest compressions and epinephrine will be continued until ROSC.
干预措施: Epinephrine (Drug)
结局指标
主要结局
Time to ROSC (Return of spontaneous Circulation)
时间窗: up to 60 Minutes of chest compression
Duration of Chest Compression until heart rate increases to greater 60 beats per minute, which is maintained for 60sec.
次要结局
- Mortality(Within the first 28 days)
- Number of Patients who have brain injury(Until infant is discharge from hospital (maximum of 30 weeks after birth))
- Number of Vasopressin doses during resuscitation(During resuscitation (up to 60 minutes))
- Admission temperature(within 60 minutes after birth)
- Number of Epinephrine doses during resuscitation(During resuscitation (up to 60 minutes))
- Cerebral regional oxygen saturation(First 72 hours after birth)
- Use of therapeutic cooling(First 72 hours after birth)
- Mode of mechanical ventilation(Until infant is discharge from hospital (maximum of 30 weeks after birth))
- Mask ventilation in the delivery room(up to 60 Minutes)
- Intubation in the delivery room(up to 60 Minutes)
- Acute Kidney injury(24 hours after birth)
- Blood gases and serum sodium levels(24-28 hours after birth)
- Blood gases and serum sodium levels(8-12 hours after birth)