Can Open Lung Strategy During Non-Invasive Respiratory Support of Very Premature Infants in the Delivery Room Reduce Non-Invasive Ventilation Failure Compared With Standard Approach? A Randomised Controlled Multicentric Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 2
- 主要终点
- SpO2 at 5th minute
研究概览
简要总结
The opening and aeration of the lung is critical for a successful transition from fetal to neonatal life. Early nasal CPAP in the delivery room in spontaneously breathing premature babies with a gestational age of 30 weeks or less is a standard treatment approach since it reduces the need for invasive mechanical ventilation and surfactant therapy. In respiratory distress syndrome (RDS) management, providing optimal lung volumes in the very early period from the beginning of delivery room approaches probably augments the expected lung protective effect. Although the benefits of CPAP support are well known, standart CPAP pressures recommended in the guidelines may not meet the needs of individual babies. Maintaining lung patency in the delivery room is the main mechanism of action of CPAP and the requirement may vary individually depending on lung physiology.
In this multicenter randomized controlled study, we aimed to compare the effects of CPAP therapy applied with a personalized open lung strategy (openCPAP), and standard CPAP therapy (standardCPAP) on oxygenation, respiratory support need and surfactant treatment requirement in preterm babies with RDS in the delivery room.
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 Minute 至 2 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born before 30 completed weeks of gestation and received early nCPAP immediately after birth in delivery room
排除标准
- •Requirement of surfactant or endotracheal intubation or positive pressure ventilation before the completion of interventions
- •Major congenital anomaly
- •Transportation to another hospital
研究组 & 干预措施
standardCPAP
Immediately after birth, early nCPAP will be started with a nasal mask with T-piece resuscitator at 6 cmH2O pressure and 0.30 fiO2. HR and preductal saturation will be evaluated every 30 seconds. The following steps will be performed according to the situation:
- If the HR > 120 / min and SpO2 be in the target range or not measurable yet: The pressure will be continue as 6 cmH2O.
- If the HR between 100-120 but SpO2 below the target range or not measured yet : The pressure will increased up to 8 cm H2O. FiO2 will be increased gradually if the patient will not respond to 8 cmH2O pressure. Pressure will be reduced to 6 cmH2O if the HR remains> 120 / min and oxygen requirement <0.30 for more than 60 seconds.
干预措施: standardCPAP (Procedure)
openCPAP
Immediately after birth, early nCPAP will be started with a nasal mask with a T-piece resuscitator with 8 cm H2O pressure and 0.30 fiO2. The heart rate (HR) and preductal saturation (SpO2) will be evaluated every 30 seconds. Individually, the following steps will be done according to the situation:
- If the HR > 120 / min and SpO2 not measured yet or be in the target range: The pressure will be continue as 8 cmH2O.
- If the HR between 100-120 but SpO2 below the target range or not measured yet : First the pressure will be increased to 10 cm H2O; than fiO2 will be increased gradually if the patient will not respond to 10 cmH2O pressure. Pressure will be reduced to 8 cmH2O if the HR remains> 120 / min and oxygen requirement <0.30 for more than 60 seconds.
干预措施: openCPAP (Procedure)
结局指标
主要结局
SpO2 at 5th minute
时间窗: 5 minute after the delivery
The oxygen saturation of the blood at 5 th minute
SpO2 at 10th minute
时间窗: 5 minute after the delivery
The oxygen saturation of the blood at 10 th minute
Incidence of invasive mechanical ventilation
时间窗: First 72 hours after the intervention
Need for intubation and mechanical ventilation (MV) Need for intubation and mechanical ventilation (MV)
Incidence of Surfactant therapy
时间窗: First 72 hours after the intervention
Surfactant therapy requirement
次要结局
- Incidence of pneumothorax(First 24 hours after the intervention)
- Incidence ofIVH (Grade 3-4)(First 72 hours after the intervention)
- Duration of ventilatory support (non-invasive)(During first hospitalisation ( an average of 10 weeks))
- Duration of invasive ventilatory support(During first hospitalisation ( an average of 10 weeks))
- Duration of oxygen (O2)(During hospitalisation ( an average of 10 weeks))
- Incidence of Surfactant treatment(During hospitalisation (an average of 10 weeks))
- Bronchopulmonary dysplasia (BPD)(At 36th postnatal week or discharge (an average of 10 weeks after intervention ) whichever came first)
- Mortality(through study completion (an average of 10 weeks))
研究者
Funda Tuzun
Assoc. Prof. Dr.
Dokuz Eylul University