Comparison of Effectiveness of Nasal CPAP and Nasal IMV in Early Rescue Surfactant Treatment in Preterm Infants
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants
研究概览
简要总结
The investigators aimed to compare the efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 2 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age 26-32 weeks
- •The criteria for failure were met by at least 1 of the following:
- •pH: 7.10 and PaCO2: 70 mm Hg
- •Recurrent apnea with >3 episodes (Prophylactic caffeine were used in all infants)
- •Single episode of apnea that required bag-and-mask ventilation
- •PaO2: 50 mmHg with a fraction of inspired oxygen of >0.5.
排除标准
- •Major congenital anomalies
- •Presence of cardiovascular instability
- •Intubation at admission to the NICU
- •Consent not provided or refused
结局指标
主要结局
Efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants
时间窗: 3 months
If infants needed invasive MV or Required a fraction of inspired oxygen of \>40% to maintain the targeted saturation of \>88% to 92%, surfactant treatment will give for respiratory distress syndrome (RDS). It means that nasal IMV or CPAP is ineffective.
次要结局
- Complications of respiratory support(3 months)
研究者
Mehmet Yekta
Zekai Tahir Burak Maternity and Teaching Hospital, Ankara
Zekai Tahir Burak Women's Health Research and Education Hospital