Early Bubble CPAP (EBCPAP) in Very Low Birth Weight Infants (VLBWI)
试验速览
- 阶段
- 4 期
- 入组人数
- 256
- 试验地点
- 15
- 主要终点
- Need for mechanical ventilation
研究概览
简要总结
The purpose of this study is to establish if a strategy of EBCPAP application in a subgroup of VLBWI, 800 to 1500g birthweight, decreases the need for mechanical ventilation in this group, without affecting mortality.
详细描述
The application of CPAP has been described as an alternative respiratory support for premature newborns with respiratory distress.Many studies support that the early use of CPAP results in a better respiratory evolution and less need for mechanical ventilation.
Hypothesis:
- The hypothesis is that EBCPAP will decrease the need for this more invasive therapy.
The primary endpoint in this multicenter controlled study is to establish if an strategy of EBCPAP application in a subgroup of VLBWI, 800 to 1500g birthweight, decreases the need for mechanical ventilation in this group, without affecting mortality. .
As secondary outcome, the investigators will analyse: days of oxygen therapy, days of mechanical ventilation, need for surfactant , pulmonary airleak, intraventricular hemorrhage, persistent ductus arteriosus, retinopathy of prematurity and bronchopulmonary dysplasia (BPD) at 28 days and 36 weeks corrected gestational age.
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
- 5 Minutes 至 30 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All infants born at the units belonging to the South American Neocosur Network with a birthweight between 800 to 1500g and breathing spontaneously at birth or after hand bagging with Neopuff or transient intubation are eligible.
- •An informed consent form should be obtained preferable prenatal.
排除标准
- •Acute life threatening congenital malformations or genetics diseases.
- •Apgar score equal or less than 3 at 5 minutes
- •Disapproval of informed consent.
结局指标
主要结局
Need for mechanical ventilation
次要结局
- Days of oxygen therapy
- Persistent ductus arteriosus
- retinopathy of prematurity
- Pulmonary airleak
- Days of mechanical ventilation
- Need for surfactant
- Intraventricular hemorrhage
- Bronchopulmonary dysplasia (BPD) at 28 days and 36 weeks corrected gestational age.