DRKS00033816尚未招募Unknown
Influence of Variation in Airway Pressure and Oscillation Frequency during High-Frequency Oscillatory Ventilation on Oxygenation and Ventilation Parameters in Preterm Infants in the Weaning Phase after Respiratory Distress Syndrome – A Randomized Clinical 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. Premature infants with a gestational age <32 weeks and a birth weight <1500g, treated at the neonatology intensive care unit of Ulm University Hospital, and at least 120 hours old.
- •2. Requirement for non-invasive ventilation (sNIPPV or nCPAP ± Backup).
- •3. FiO2 under CPAP-Backup/NIPPV 21% - 60% with a PEEP of 4-8 cmH2O.
- •4. At least 4 episodes of hypoxemia (<80% SpO2) and/or apnea/bradycardia in the 12 hours before study entry.
- •5. In the 12 hours before study entry, the number of irritated/intervention-requiring events (defined as SpO2 <70% for >1min or heart rate <100/min for >30 seconds) did not lead to an escalation of non-invasive ventilation.
- •6. Written consent of the legal guardians 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 protect the minimal-handling principle in the critical phase for the prevention of intraventricular bleeding).
- •3. Onset of treatment for an acute clinical infection <72 hours before study entry.
- •4.FiO2 under CPAP/NIPPV >60% and/or PEEP >8cmH2O.
- •5. Escalation of non-invasive ventilation in the 12 hours before study entry due to the number of irritated/intervention-requiring events (defined as SpO2 <70% for >1min or heart rate <100/min for >30 seconds).
- •6. Planned blood transfusion or surgery during the study phase.
- •7. Study initiation <48 hours after immunization.
- •8. ROP examination on study days.
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