Randomised Controlled Trial of Pressure-limited Ventilation Versus Volume-targeted Ventilation in Prematurely Born Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Time to achieve weaning criteria
研究概览
简要总结
Aims: There is increasing evidence that volume-targeted ventilation (VTV) holds benefits for preterm infants in comparison to pressure-limited ventilation. This study aims to compare pressure-limited to VTV in preterm infants.
Hypothesis: Volume-targeted will be associated with more rapid achievement of weaning criteria compared to pressure-limited ventilation
Primary outcome: Time taken to achieve pre-specified weaning criteria.
Methods: Ventilated infants less than 34 weeks gestational age at birth were recruited within the first 24 hours of life and randomly allocated to receive either pressure-limited or VTV. Adjustments to ventilator settings were made according to the trial protocol. Infants were deemed to have met failure criteria if they required HFOV, required peak pressures of more than 26 cm of water or developed pulmonary haemorrhage. Analysis will be by intention-to-treat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mechanically ventilated
- •<34 weeks gestation
- •Within first 24 hours of life
排除标准
- •Congenital diaphragmatic hernia
- •Congenital heart disease
- •Oesophageal atresia
研究组 & 干预措施
Pressure-limited ventilation
干预措施: Ventilation protocol delivered by the SLE5000 ventilator (Device)
Volume-targeted ventilation
干预措施: Ventilation protocol delivered by the SLE5000 ventilator (Device)
结局指标
主要结局
Time to achieve weaning criteria
Peak inspiratory pressure (PIP) of 16 cm of water or less AND fraction of inspired oxygen of 0.4 or less for at least 6 hours
次要结局
未报告次要终点
研究者
Anne Greenough
Professor of Neonatology and Clinical Respiratory Physiology
King's College London