ACTRN12623000203651招募中未知
A single-centre, controlled, within-patient, multi-period study to assess the non-inferiority and safety of a neonatal flow generator to deliver variable-flow CPAP to premature infants requiring respiratory support.
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 15
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 34 Weeks 至 200 Days（—）
- 性别
- All
入选标准
- •Born at GA equal to or greater than 34 weeks
- •Clinical decision that the baby should continue variable-flow CPAP therapy for the next 6 hours
- •Infant is stable for >3 hours before 1 hour observation period on a variable-flow CPAP pressure between 4 and 10 cmH2O with FiO2 less than or equal to 0.3 oxygen requirement, with a respiratory rate of <70 breaths/min and without significant desaturation or bradycardia events (defined at spontaneous events with oxygen saturation levels < 80%, heart rate <100 beats/min and requiring nursing intervention).
- •Infants will be discussed with the attending neonatologist as to their suitability relative to the study protocol on the morning ward round, and the ultimate discretion remains at all times with the neonatologist responsible for the infant’s care.
排除标准
- •Infants with congenital abnormalities, suspected chromosomal abnormalities or other conditions which would exclude the use of variable-flow CPAP.
- •Prenatal asphyxia (Apgar score less than 5 at minute 5, Cord pH less than 7, and Lactate > 6)
- •Infants with notifiable diseases.
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