NCT03298035已完成不适用
A Comparison of Non-invasive Ventilation Methods Used to Prevent Endotracheal Intubation Due to Apnea in Very Low Birth Weight Infants
The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2017年11月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Number of Participants Who Were Intubated
研究概览
简要总结
The purpose of this study is to determine whether nasal intermittent positive pressure ventilation (NIPPV) reduces the need for endotracheal intubation in very low birth weight infants with persistent apnea who fail nasal continuous positive airway pressure (NCPAP).
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born at < 30 weeks gestational age who develop clinically significant apnea while on NCPAP > 6cm H2O or whose team is considering intubation due to apnea. Consider clinically significant apnea as 1 or more events treated with bag-mask ventilation or 3 episodes of apnea requiring stimulation within 1 hour.
- •Infants on maximum caffeine therapy (10mg/kg/day)
排除标准
- •Major congenital anomalies including congenital heart disease
结局指标
主要结局
Number of Participants Who Were Intubated
时间窗: 28 days after randomization
Duration of Intubation
时间窗: 28 days after randomization
次要结局
- Number of Apneic Events(28 days after randomization)
- Number of Participants With Bronchopulmonary Dysplasia (BPD)(36 weeks corrected gestational age)
- Length of Hospital Stay(about 10 to 18 weeks)
- Number of Participants Who Died(until discharge (about 10 to 18 weeks) or death)
- Number of Participants With Necrotizing Enterocolitis (NEC)(36 weeks corrected gestational age)
- Number of Participants With Air Leak Disorders(36 weeks corrected gestational age)
- Weight Gain(36 weeks corrected gestational age)
研究者
Catherine Claire Beaullieu
Neonatal-Perinatal Medicine Fellow
The University of Texas Health Science Center, Houston
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Effects of Two Modalities of Non-invasive Ventilation After Extubation in Very Low Birth Weight NeonatesPreterm InfantNCT03551314Federal University of Minas Gerais17
Unknown
3 期
Non Invasive Ventilation Versus Continuous Positive Airway Pressure After Extubation of Very Low Birth Weight Infants.Neonatal Respiratory FailureNCT01778829Pontificia Universidad Catolica de Chile220
Unknown
不适用
Nasal Intermittent Positive Pressure Ventilation(NIPPV) vs Continuous Positive Airway Pressure for Respiratory Distress SyndromeNasal Intermittent Positive Pressure VentilationNasal Continuous Positive Airway PressureNCT03226977Daping Hospital and the Research Institute of Surgery of the Third Military Medical University1,000
已完成
不适用
Nasal Intermittent Positive Pressure Ventilation During Neonatal IntubationRespiratory Distress SyndromeNewborn MorbidityDesaturation of BloodVentilator Lung NewbornDifficult or Failed IntubationNCT06549283Muğla Sıtkı Koçman University146
招募中
不适用
Evaluation of Nasal Non Invasive Ventilation in Management of Neonates With Respiratory Distress Using Lung UltrasoundPretermVentilator Lung NewbornNCT06550219Alexandria University30