Nasal Intermittent Positive Pressure Ventilation Versus Nasal Continuous Positive Airway Pressure Durante la Somministrazione Del Surfattante Con Tecnica LISA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 2
- 主要终点
- Surfactant or mechanical ventilation
研究概览
简要总结
The goal of this randomized controlled study is to compare the efficacy of using NIPPV versus NCPAP during the LISA procedure in very preterm infants.
The main question it aims to answer is:
• Does NIPPV during the LISA procedure decrease the need for a second dose of surfactant or the need of mechanical ventilation during the first 72 hours of life in comparison with NCPAP? Infants with gestational age between 25+0 and 31+6 weeks of gestation with RDS who do not require VM and treated with NCPAP and FiO2 >0.30 within the first 6 hours of life who received the first dose of caffeine will be eligible for enrollment in the study Participants will be randomized to receive surfactant with conventional LISA procedure, i.e. performed during NCPAP, or with LISA procedure performed during NIPPV.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 0 Hours 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •-Infants with gestational age between 25+0 and 31+6 gestational weeks,
- •-RDS which does not require MV
- •-Treatment with NCPAP and FiO2 >0.30 within the first 6 hours of life,
- •-First dose of caffeine administered
排除标准
- •-absence of informed consent,
- •-major congenital malformations,
- •-hydrops fetalis,
- •-chromosomal diseases,
- •-previous treatment with surfactant,
- •-cardiorespiratory instability requiring treatment with vasoactive drugs,
- •-pneumothorax,
- •-death within 72 hours of life.
结局指标
主要结局
Surfactant or mechanical ventilation
时间窗: The need for a second dose of surfactant or mechanical ventilation will be evaluated within the first 72 hour of life
Need for a second dose of surfactant or mechanical ventilation
次要结局
- Mechanical ventilation(Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks)
- Noninvasive ventilation(Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks)
- Bronchopulmonary dysplasia(Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks)
研究者
Carlo Dani
Full Professor of Pediatrics
University of Florence