Nasal Intermittent Mandatory Ventilation Versus Continuous Positive Airway Pressure After Extubation of Very Low Birth Weight Infants of the NEOCOSUR Network.
试验速览
- 阶段
- 3 期
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Extubation failure
研究概览
简要总结
The purpose of this study is to determine whether Nasal intermittent positive pressure ventilation (NIPPV) non synchronized is better than continuous positive airway pressure (NCPAP)in preventing extubation failure within 72 h, after extubation of very low birth weight infants at the NEOCOSUR Network.
详细描述
Is a Randomized trial to preterms infants <1500g and less than 34 weeks with RDS requiring machanical ventilation in the extubation period, randomized to receive NIPPV or NCPAP once extubation criteria were met. Parental written informed consent is required previous extubation. The failure rate is defined as the need for re-intubation and mechanical ventilation).
Exclusion criteria are: major congenital anomalies; presence of cardiovascular instability;intubation less than 2 hours; mechanical ventilation more than 14 days, using muscle relaxant, airway anomalies, consent not provided or refused.
Outcome measures:
The primary outcome was to assess the need for re-intubation within the first 72 hours after extubation in the 2 groups.
The criteria for failure were met by at least 1 of the following:
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
- 2 Hours 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm with a weight less than 1501 g
- •Gestational age less or equal to 34 weeks
- •Preterm that meets extubation criteria after at least 2 hours and less than 14 days connected to mechanical ventilation
- •Patient receiving methylxanthynes
排除标准
- •Patient more than 14 days in mechanical ventilation
- •Newborn with congenital cardiopathy
- •Newborn with congenital malformation
- •Newborn wirh chromosomopathy or genopathic disease
- •Newborn with suspected gastrointestinal disease
- •Newborn with neuromuscular disease or receiving muscle relaxants
- •Lack or informed consent signed by parents or legal representative
结局指标
主要结局
Extubation failure
时间窗: apnea rate and respiratory failure.
The criteria for failure were met by at least 1 of the following: pH less than 7.25 and PaCO2 over 65 mmHg; recurrent apnea more than 2 episodes per hour associated with bradycardia; during 4 hour continuous; 2 episodes of apnea that required bagand-mask ventilation in any time during the study; or a PaO2 less than 50 mm Hg with a fraction of inspired oxygen over 0.6.
次要结局
未报告次要终点
研究者
Alberto Estay
MD
Pontificia Universidad Catolica de Chile