DRKS00023438已完成不适用
Influence of non-invasive positive pressure ventilation versus nasal high-frequency oscillation ventilation on parameters of oxygenation and ventilation in premature infants in the weaning phase after respiratory distress syndrome
Menschen für Kinder e.V.0 个研究点目标入组 24 人开始时间: 2021年5月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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
- 3 Days 至 44 Pregnancy（—）
- 性别
- All
入选标准
- •1. Premature babies with a gestational age <32 weeks of gestation and a birth weight <1500 g, who are treated in the neonatal intensive care unit of the University Hospital Giessen and are at least 72 hours old.
- •2. Requirement of non-invasive ventilation (CPAP / NIPPV.
- •3. FiO2 under CPAP / NIPPV 21 % - 60% with a PEEP of 5-8 cmH20
- •4. At least 4 hypoxemias (<80% SpO2) and / or apneas / bradycardias in the 12 hours prior to study entry.
- •5. In the 12 hours prior to study entry, the number of intervention-requiring events (defined as SpO2 <70% for> 1min or heart rate <100 / min for> 30 seconds) does not lead to an escalation of the non-invasive ventilation.
- •6. Written consent of the legal guardian is given.
排除标准
- •1. Premature babies and newborns with severe malformations that significantly impair respiratory regulation (severe CNS malformations), lung function (e.g. pulmonary hypoplasia, acute extra-alveolar air such as pneumothorax and pulmonary interstitial emphysema, diaphragmatic hernias) or the circulatory function (congenital cyanotic heart disease, septic shock).
- •2. Postnatal age <72 hours of life (often acute deterioration in the early phase of a respiratory distress syndrome and to protect the minimal handling principle in the critical phase to prevent intraventricular bleeding).
- •3. Start of treatment for an acute clinical infection <72 hours before study entry.
- •4. FiO2 under CPAP / NIPPV> 60% and / or PEEP> 8cmH20.
- •5. Escalation of non-invasive ventilation in the 12 hours before study entry due to the number of intervention-requiring events (defined as SpO2 <70% for> 1 min. or Heart rate <100 / min. for> 30 seconds).
- •6. Planned blood transfusion or surgery during the study phase.
研究者
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