DRKS00031911招募中Unknown
Influence of different settings of apnoea duration under CPAP backup ventilation in small preterm infants during weaning phase after respiratory distress syndrome - a prospective randomised clinical cross-over study
niversitätsklinikum Ulm, Klinik für Kinder-und Jugendmedizin, Sektion Neonatologie und pädiatrische Intensivmedizin0 个研究点目标入组 24 人开始时间: 2023年5月26日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 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
- 5 Days 至 32 Pregnancy（—）
- 性别
- All
入选标准
- •< 1500g birthweight and at least 120 old
- •- requirement for non-invasive ventilation (CPAP or CPAP backup).
- •- FiO2 on CPAP or CPAP backup 21% - 60% with a PEEP of 4-8 cmH20.
- •- at least 4 hypoxaemias (<80% SpO2) and/or apnoeas (>20 seconds
- •duration) and/or bradycardias (heart rate <100/min) in the 12 hours
- •before 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 < 100/min for > 30
- •seconds) did not lead to escalation of non-invasive ventilation
- •- written consent of the legal guardian is given
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 an acute clinical infection < 72 hours prior to
- •study entry
- •- FiO2 on 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 ventilator, as this will administer ventilator
- •breaths when SpO2 falls below the set saturation target range.
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