CPAP Application at Delivery Room at Very Low Birth Weight Infants
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 主要终点
- Necessity of mechanical ventilation and surfactant during the first 5 days of life
研究概览
简要总结
The objective of the study is to determine if CPAP applied within less than 15 min of life in the DR reduces the necessity of mechanical ventilation and surfactant during the first 5 days of life.
详细描述
A multicenter prospective cohort of inborn preterm infants, born at 8 public university NICU in Brazil, with birthweight 1000-1499 g, without malformations, not intubated at 15 minutes of life. Preterm infants will be randomly assigned at birth to an early treatment group (DR-CPAP), in which CPAP of 5 cm water pressure is applied within 15 minutes after birth by Neopuff, or to a routine group (RG), in which CPAP is applied when indicated by the assistant physician. After transfer to the NICU, nasal CPAP will be maintained with Hudson prongs
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Minute 至 15 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth weight 1000g to 1500g
- •No major malformations
排除标准
- •Necessity of intubation
- •Maternal decision
结局指标
主要结局
Necessity of mechanical ventilation and surfactant during the first 5 days of life
时间窗: 5 days
次要结局
- Maternal and infant characteristics associated with CPAP failure during the first 15 minutes of life(15 minutes)
- Incidence of pneumothorax, interstitial emphysema, ductus arteriosus, peri- intra-ventricular hemorrhage, sepsis, necrotizing enterocolitis(30 days)
- Oxygen use(36 weeks of corrected age)
- Retinopathies of prematurity(Hospital stay)
- Death during hospitalization(Hospital stay)