Effects of closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C) on outcome of extremely preterm infants – a randomized controlled parallel group multicenter trial for safety and efficacy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 865
- 试验地点
- 27
- 主要终点
- The primary outcome I is a composite of any of the following: • Death • Severe retinopathy of prematurity (severe ROP, as defined in 7.3.1) • Chronic lung disease of prematurity (BPD, according to the physiological definition as defined in 7.3.2) • Necrotizing enterocolitis (NEC, as defined in 7.3.3) until discharge from hospital
研究概览
简要总结
To assess the effect of efficacy of closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C) provided in standard infant ventilators in addition to manual adjustments of the inspired oxygen fraction (FiO2) during mechanical ventilation, continous positive airway pressure (CPAP) or any other positive pressure respiratory support compared to manual adjustments of the FiO2 only on the primary enpoints.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •GA at birth 23+0/7 to 27+6/7 weeks
排除标准
- •Decision not to provide full life support / decision for palliative care only before study entry
- •Severe congenital abnormalities (particularly those affecting respiratory, cardiovascular, or gastrointestinal function or long-term neuro-cognitive development, whereas a patent ductus arteriosus or a PFO/ASDII is not considered a congenital anomaly in preterm infants)
- •Postnatal age >48h
- •Lack of device enabling closed-loop automatic control of FiO2 before randomization
结局指标
主要结局
The primary outcome I is a composite of any of the following: • Death • Severe retinopathy of prematurity (severe ROP, as defined in 7.3.1) • Chronic lung disease of prematurity (BPD, according to the physiological definition as defined in 7.3.2) • Necrotizing enterocolitis (NEC, as defined in 7.3.3) until discharge from hospital
The primary outcome I is a composite of any of the following: • Death • Severe retinopathy of prematurity (severe ROP, as defined in 7.3.1) • Chronic lung disease of prematurity (BPD, according to the physiological definition as defined in 7.3.2) • Necrotizing enterocolitis (NEC, as defined in 7.3.3) until discharge from hospital
The primary outcome II is a composite of any of the following: • death or neurodevelopmental impairment (defined as at least one of the following components: motor disability (GMFCS 2-5), language or cognitive delay (language composite score < 85 or cognitive composite score < 85 on Bayley Scales of Infant Development, 3rd edition) or severe visual or hearing impairment (need for a hearing aid or cochlear implant)) at 24 months corrected age.
The primary outcome II is a composite of any of the following: • death or neurodevelopmental impairment (defined as at least one of the following components: motor disability (GMFCS 2-5), language or cognitive delay (language composite score < 85 or cognitive composite score < 85 on Bayley Scales of Infant Development, 3rd edition) or severe visual or hearing impairment (need for a hearing aid or cochlear implant)) at 24 months corrected age.
次要结局
- Individual components of the primary outcome variables and developmental scores of the Bayley Scales of Infant Development (3rd edition)
研究者
Prof. Axel Franz
Scientific
Universitaetsklinikum Tuebingen AöR