Comparison of Two Different NCPAP 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
- 400
- 试验地点
- 2
- 主要终点
- noninvasive ventilation failure
研究概览
简要总结
is to compare introduction of two different NCPAP methods 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
Study Design NCPAP support was provided with continuous positive airway pressure, which was generated by a neonatal ventilator (SLE; Infant Flow System, Viasys Corp., USA) and infant flow-driver device (SLE; The respiratory parameter settings were a PEEP of 5-8 cmH2O. CPAP was stopped when PEEP 5 cmH2O and infants showed no signs of RDS with FiO2 <0.30.
Under non-invasive respiratory support, in case of FiO2 is ≥ 0.40, surfactant will be given as early rescue therapy by means of non-invasive method (by using a thin catheter - take care method- while spontaneous breathing continues) in order to keep target oxygen saturation between 90-95 %. The second dose of surfactant will be given 6 hours after the first dose by means on non-invasive method in order to keep target oxygen saturation between 90-95 % in case of FiO2 need is ≥ 0.30.
Non-invasive respiratory support failure is set as follows:
- FiO2 of ≥ 0.50 in order to keep oxygen saturation measured by pulse oximetry above 90 % and higher,
- Apnea requiring more than 6 alerts in a 24 -hour period in 6 consecutive hours or more than 1 apnea requiring positive pressure ventilation,
- Persistent acidosis; presence of pH < 7.20 and PCO2 > 65 mmHg in two different blood gases drawn with an interval of at least 30 minutes or treatment-resistant metabolic acidosis,
- Severe respiratory distress,
- Pulmonary haemorrhage and cardiopulmonary arrest.
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 2 Hours(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 with RDS signs 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
Ventilator NCPAP
neonatal ventilator (SLE; Specialised Laboratory Equipment, UK) PEEP: 5 cmH2O
干预措施: ventilator NCPAP (Device)
Infant Flow-driver NCPAP
infant flow-driver device (Infant Flow System, Viasys Corp., USA) PEEP:5-8 cmH2O, This group receive variable flow
干预措施: ventilator NCPAP (Device)
结局指标
主要结局
noninvasive ventilation failure
时间窗: 72 hours
need for mechanical ventilation in the first 72 hours of life
次要结局
未报告次要终点
