DRKS00031963尚未招募Unknown
Influence of high-flow nasal cannula versus O2 nasal cannula on parameters of oxygenation and ventilation in small preterm infants in weaning from respiratory support - a prospective randomised clinical trial
niversitätsklinikum Ulm, Klinik für Kinder-und Jugendmedizin, Sektion Neonatologie und pädiatrische Intensivmedizin0 个研究点目标入组 60 人开始时间: 2023年5月30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
- 60
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
- •Preterm infants with a gestational age <32 weeks of gestation and a birth
- •weight <1500g
- •- Requirement for non-invasive ventilation (CPAP or CPAP backup)
- •- FiO2 on CPAP or CPAP backup 21% - 60% at a PEEP of 4-8
- •- At least 4 hypoxaemias (< 80% SpO2) and/or apnoeas (>20
- •seconds duration) and/or bradycardia (heart rate <100/min) in the
- •12 hours prior to study entry
- •- In the 12 hours prior to study entry, the number of
- •irritable/intervention events (defined as SpO2 < 70% for > 1min or heart
- •rate for > 1min or heart rate < 100/min for > 30 seconds) did not result in
- •an Escalation of non-invasive ventilation
- •- Written consent of the legal guardian has been obtained
排除标准
- •- premature and newborn infants 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 circulatory function (congenital cyanotic cardiac vitals, severe
- •septic shock)
- •- postnatal age <120 hours of life (often acute deterioration in the early
- •phase of respiratory distress syndrome and to protect the minimal
- •handling principle in the critical phase to prevent intraventricular
- •haemorrhage)
- •- initiation of treatment for acute clinical infection < 72 hours prior to study
- •- FiO2 under CPAP or CPAP backup >60% and/or PEEP > 8cmH20
- •- escalation of non-invasive ventilation in the 12 hours prior to study entry
- •due to the number of irritable/intervention events (defined as SpO2 <
- •70% for > 1min or heart rate < 100/min for > 30 seconds)
- •- planned blood transfusion or surgery during the study period
- •- activated FiO2 controller on the ventilator, as this will administer
- •ventilator breaths when SpO2 falls below the set saturation target range
研究者
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