CTIS2024-511335-10-01进行中（未招募）1 期
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 - FiO2-C
niversitaetsklinikum Tuebingen AöR0 个研究点目标入组 1,082 人开始时间: 2024年8月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,082
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 17（—）
- 性别
- All
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
研究者
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A trial funded by the German Federal Ministry for Education and Research (BMBF) to evaluate the effects of closed-loop automatic control of inspiratory fraction of oxygen in comparison to manual control in extremly preterm infants with respect to complications of prematurity potentially related to inadequate administration of oxygen (ROP, NEC, BPD) and mortality as well as the neurocognitive outcome after 24 months2024-511335-10-01Universitaetsklinikum Tuebingen AöR865
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