Comparison of Nasal Intermittent Positive Airway Pressure and Nasal Bi-level Positive Airway Pressure Methods in Preterm Infants With Respiratory Distress Syndrome With Gestational Age of 26-30 Weeks
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 325
- 试验地点
- 2
- 主要终点
- surfactant requirement
研究概览
简要总结
Purpose is to compare introduction of NIPPV (Nasal Intermittent Positive-Pressure Ventilation) and nBiPAP (Nasal Bi-level Positive Airway Pressure) in terms of mechanical ventilation (MV) need (non-invasive respiratory support failure) and surfactant need within the first 72 hours of life in preterm infants with Respiratory Distress Syndrome (RDS) at 26-30 weeks of gestation.
详细描述
Purpose is to compare introduction of NIPPV and nBiPAP in terms of mechanical ventilation (MV) need (non-invasive respiratory support failure) and surfactant need within the first 72 hours of life in preterm infants with Respiratory Distress Syndrome (RDS) at 26-30 weeks of gestation.
Method
Primary Outcome Measures:
In NIPPV and BIPAP groups, comparison of mechanical ventilation (MV) need (non-invasive respiratory support failure) and surfactant need within the first 72 hours of life
Secondary Outcome Measures:
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
- 1 Hour 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infant with gestational age of 26 weeks 0 days and 29 weeks 6 days will be included.
排除标准
- •Major congenital anomalies
- •Presence of cardiovascular instability
- •Intubation at admission to the NICU
- •Consent not provided or refused
研究组 & 干预措施
NIPPV
noninvasive respiratory support devices
This group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment.
干预措施: noninvasive respiratory support devices (Device)
BİPAP
noninvasive respiratory support devices
This group receive Bi-Level Positive Airway Pressure (BIPAP) treatment.
干预措施: noninvasive respiratory support devices (Device)
结局指标
主要结局
surfactant requirement
时间窗: 72 HOURS
surfactant requirement within the first 72 hours of life
次要结局
未报告次要终点