DRKS00033767尚未招募Unknown
Influence of different settings of the FiO2 controller under CPAP±Backup ventilation in small preterm infants in the weaning phase after respiratory distress syndrome – a prospective randomized clinical cross-over study.
niversitätsklinikum Ulm, Klinik für Kinder-und Jugendmedizin, Sektion Neonatologie und pädiatrische Intensivmedizin0 个研究点目标入组 36 人开始时间: 2024年5月10日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 5 Days 至 32 Weeks（—）
- 性别
- All
入选标准
- •1. Preterm infants with a gestational age <32 weeks and birth weight <1500g, receiving treatment in the neonatology section of the intensive care unit at the University Hospital Ulm and aged at least 120 hours.
- •2. Requirement for non-invasive ventilation (CPAP or CPAP-Backup).
- •3.FiO2 under CPAP±Backup = 21%.
- •4. At least 4 episodes of hypoxemia (<80% SpO2) and/or apneas (>20 seconds duration) and/or bradycardias (heart rate <100/min) in the 12 hours preceding study enrollment.
- •5. In the 12 hours preceding study enrollment, the number of provoked/intervention-requiring events (defined as SpO2 < 70% or heart rate <100/min) did not lead to escalation of non-invasive ventilation.
- •6. Written consent from the legal guardians has been obtained.
排除标准
- •1. Preterm and newborn infants with severe malformations affecting respiratory regulation (severe CNS malformations), lung function (e.g., lung hypoplasia, acute extra-alveolar air such as pneumothorax and pulmonary interstitial emphysema, diaphragmatic hernias), or cardiovascular function significantly (congenital cyanotic heart defects, severe septic shock).
- •2. Postnatal age <120 hours (often acute deterioration in the early phase of respiratory distress syndrome and to adhere to the minimal-handling principle during the critical phase to prevent intraventricular hemorrhage).
- •3. Initiation of treatment for an acute clinical infection <72 hours before study enrollment.
- •4. Escalation of non-invasive ventilation in the 12 hours preceding study enrollment due to the number of provoked/intervention-requiring events (defined as SpO2 <70% or heart rate <100/min).
- •5. Planned blood transfusion or surgery during the study phase.
- •6. Study initiation <48 hours after immunization.
- •7. Retinopathy of prematurity (ROP) examination on study days.
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