Randomized Trial Investigating Four Nasal CPAP Systems in the Management of Apnea of Prematurity
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 主要终点
- Cumulative percentage of bradycardia (heart rate <80 beats/min) and desaturation (SaO2 <80%) per hour
研究概览
简要总结
The purpose of this study is to evaluate four different nasal continuous pressure systems, which are usually applied on our neonatal intensive care unit, with regard of their effect on bradycardia and desaturations in preterm infants.
详细描述
BACKGROUND:
Apnea of prematurity (AOP) is a common problem in preterm infants. Nasal respiratory support using either Continuous Positive Airway Pressure (CPAP) or Intermittent Mandatory Ventilation (IMV) are, among others, widely used treatments. Which of the different systems is the most efficient, however, is unclear.
OBJECTIVE:
Efficiency of different CPAP systems on reducing the cumulative percentage of bradycardia and desaturation in preterm infants.
METHODS:
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
- Single
入排标准
- 年龄范围
- — 至 14 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gestational age at birth < 34 weeks
- •postconceptional age and body weight at study ≤38 week and >1000 g
- •requirement for N-CPAP to treat AOP as judged by the attending neonatologist
排除标准
- •congenital or chromosomal abnormalities
- •acute infections
- •intraventricular hemorrhage
- •additional inspired oxygen to maintain pulse oximeter saturation SpO2 >92%
- •patent ductus arteriosus
结局指标
主要结局
Cumulative percentage of bradycardia (heart rate <80 beats/min) and desaturation (SaO2 <80%) per hour
时间窗: one year
次要结局
- - Event rates for central apneas, desaturations and bradycardias calculated as the number of respective events per hour of artefact free recording time - relative cumulative event time - baseline heart rate, respiratory rate and oxygen saturation(one year)