Heart Rate Evaluation and Resuscitation Trial in Preterm Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Time to Infant Stabilization
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 1 Hour（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control group
Pulse oximeter and auscultation to determine heart rate during neonatal resuscitation. Pulse oximeter will be used to determine oxygen saturation.
干预措施: Pulse oximeter and auscultation group (Other)
Electrocardiogram group
Electrocardiogram to determine heart rate during neonatal resuscitation. Pulse oximeter will still be used per Neonatal Resuscitation Program guidelines for oxygen saturation.
干预措施: Electrocardiogram group (Other)
结局指标
主要结局
Time to Infant Stabilization
时间窗: 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)
次要结局
- Incidence of CPR(During delivery room resuscitation, up to 1 hour)
- Incidence of intubation(During delivery room resuscitation, up to 1 hour)
- Incidence of hypothermia(Until hospital discharge, up to 6 months)
- Time to heart rate >100 beats per minute(During delivery room resuscitation, up to 1 hour)
- Time to goal oxygen saturation(During delivery room resuscitation, up to 1 hour)
- Time of positive pressure ventilation(During delivery room resuscitation, up to 1 hour)
- Incidence of positive pressure ventilation(During delivery room resuscitation, up to 1 hour)
- Incidence of necrotizing enterocolitis(Until hospital discharge, up to 6 months)
- Incidence of respiratory distress syndrome(Until hospital discharge, up to 6 months)
- Maximum FiO2 applied(During delivery room resuscitation, up to 1 hour)
- Maximum peak inspiratory pressure(During delivery room resuscitation, up to 1 hour)
- Incidence of need for surfactant(Until hospital discharge, up to 6 months)
- Incidence of bronchopulmonary dysplasia(Until hospital discharge, up to 6 months)
- Incidence of pneumothorax(Until hospital discharge, up to 6 months)
- Incidence of intraventricular hemorrhage(Until hospital discharge, up to 6 months)
- Incidence of sepsis(Until hospital discharge, up to 6 months)
- Incidence of appropriate vs inappropriate use of positive pressure ventilation(During delivery room resuscitation, up to 1 hour)
- Incidence of symptomatic PDA(Until hospital discharge, up to 6 months)
- Incidence of equipment failure of pulse oximeter and electrocardiogram(During delivery room resuscitation, up to 1 hour)
研究者
Vishal Kapadia
Assistant Professor of Pediatrics
University of Texas Southwestern Medical Center