Heart Rate Evaluation and Resuscitation Trial in Preterm Neonates (HEART)
2018年12月19日 更新者：Vishal Kapadia、University of Texas Southwestern Medical Center
The purpose of this study is to determine whether using electrocardiograms (ECGs) during resuscitation of preterm infants (less than 31 weeks gestation) will decrease the amount of time it takes from birth for heart rate (HR) to be above 100 beats per minute and oxygen saturations to be in the goal range, in other words to stabilize the infant.
A few studies have been conducted which showed that ECGs are faster at detecting HR than pulse oximetry (PO).
Sample sizes, however, have been small and only few extremely low birthweight infants have been included.
It is unclear if use of ECG in these tiny preterm infants in addition to traditional techniques to determine HR will be beneficial and impact resuscitation and outcomes.
The investigators propose a study where infants will be randomized to either using ECG in addition to PO ± auscultation versus PO ± auscultation only to assess HR during neonatal resuscitation.
The investigators hypothesize that the group of infants randomized to ECG will be able to stabilize faster, i.e. achieve HR > 100 beats per minute and oxygen saturation in goal range faster.
研究概览
研究类型
介入性
注册 (实际的)
51
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Texas
-
Dallas、Texas、美国、75235
- Parkland Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
不超过 1小时 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Preterm infants less than <31 weeks gestation born at Parkland hospital vaginally or by C/S
- Infant with congenital heart disease, congenital anomalies, or chromosomal abnormalities will be included unless comfort care has been agreed upon beforehand
- Resuscitation team present to attend delivery before birth
Exclusion Criteria:
- Any infant with prenatally agreed upon comfort care since resuscitation will not be provided
- Any precipitous delivery since resuscitation team will not be in attendance prior to delivery
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Control group
Pulse oximeter and auscultation to determine heart rate during neonatal resuscitation.
Pulse oximeter will be used to determine oxygen saturation.
|
Control
|
|
实验性的：Electrocardiogram group
Electrocardiogram to determine heart rate during neonatal resuscitation.
Pulse oximeter will still be used per Neonatal Resuscitation Program guidelines for oxygen saturation.
|
Experimental
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to Infant Stabilization
大体时间：During delivery room resuscitation, up to 1 hour
|
Amount of time it takes from birth for heart rate to be above 100 beats per minute and oxygen saturation to be in the goal range (per Neonatal Resuscitation Program guidelines)
|
During delivery room resuscitation, up to 1 hour
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to heart rate >100 beats per minute
大体时间：During delivery room resuscitation, up to 1 hour
|
Time in delivery room
|
During delivery room resuscitation, up to 1 hour
|
|
Time to goal oxygen saturation
大体时间：During delivery room resuscitation, up to 1 hour
|
Time in delivery room
|
During delivery room resuscitation, up to 1 hour
|
|
Time of positive pressure ventilation
大体时间：During delivery room resuscitation, up to 1 hour
|
Total time positive pressure received in delivery room
|
During delivery room resuscitation, up to 1 hour
|
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Incidence of positive pressure ventilation
大体时间：During delivery room resuscitation, up to 1 hour
|
Positive pressure ventilation applied in delivery room
|
During delivery room resuscitation, up to 1 hour
|
|
Incidence of CPR
大体时间：During delivery room resuscitation, up to 1 hour
|
CRP applied in delivery room
|
During delivery room resuscitation, up to 1 hour
|
|
Incidence of intubation
大体时间：During delivery room resuscitation, up to 1 hour
|
Intubation in delivery room
|
During delivery room resuscitation, up to 1 hour
|
|
Maximum FiO2 applied
大体时间：During delivery room resuscitation, up to 1 hour
|
FiO2 applied in delivery room
|
During delivery room resuscitation, up to 1 hour
|
|
Maximum peak inspiratory pressure
大体时间：During delivery room resuscitation, up to 1 hour
|
Maximum peak inspiratory pressure in delivery room
|
During delivery room resuscitation, up to 1 hour
|
|
Incidence of hypothermia
大体时间：Until hospital discharge, up to 6 months
|
Hypothermia on admission to NICU
|
Until hospital discharge, up to 6 months
|
|
Incidence of need for surfactant
大体时间：Until hospital discharge, up to 6 months
|
Surfactant given while in NICU
|
Until hospital discharge, up to 6 months
|
|
Incidence of bronchopulmonary dysplasia
大体时间：Until hospital discharge, up to 6 months
|
Incidence in NICU
|
Until hospital discharge, up to 6 months
|
|
Incidence of respiratory distress syndrome
大体时间：Until hospital discharge, up to 6 months
|
Incidence in NICU
|
Until hospital discharge, up to 6 months
|
|
Incidence of pneumothorax
大体时间：Until hospital discharge, up to 6 months
|
Incidence in NICU
|
Until hospital discharge, up to 6 months
|
|
Incidence of intraventricular hemorrhage
大体时间：Until hospital discharge, up to 6 months
|
Incidence in NICU
|
Until hospital discharge, up to 6 months
|
|
Incidence of necrotizing enterocolitis
大体时间：Until hospital discharge, up to 6 months
|
Incidence in NICU
|
Until hospital discharge, up to 6 months
|
|
Incidence of sepsis
大体时间：Until hospital discharge, up to 6 months
|
Incidence in NICU
|
Until hospital discharge, up to 6 months
|
|
Incidence of symptomatic PDA
大体时间：Until hospital discharge, up to 6 months
|
Incidence in NICU
|
Until hospital discharge, up to 6 months
|
|
Incidence of appropriate vs inappropriate use of positive pressure ventilation
大体时间：During delivery room resuscitation, up to 1 hour
|
Use in delivery room
|
During delivery room resuscitation, up to 1 hour
|
|
Incidence of equipment failure of pulse oximeter and electrocardiogram
大体时间：During delivery room resuscitation, up to 1 hour
|
Failure in delivery room
|
During delivery room resuscitation, up to 1 hour
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年6月13日
初级完成 (实际的)
2018年3月23日
研究完成 (实际的)
2018年3月23日
研究注册日期
首次提交
2017年4月22日
首先提交符合 QC 标准的
2017年4月25日
首次发布 (实际的)
2017年4月28日
研究记录更新
最后更新发布 (实际的)
2018年12月21日
上次提交的符合 QC 标准的更新
2018年12月19日
最后验证
2018年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.