ACTRN12619000535178已完成未知
A single-centre, randomized, un-blinded, controlled, multi-period studyto assess the non-inferiority and safety of a neonatal flow generator todeliver bubble CPAP to premature infants requiring respiratorysupport.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 10
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
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 6 Hours 至 7 Weeks（—）
- 性别
- All
入选标准
- •Born at GA greater than or equal to 33 weeks
- •Clinical decision that the baby should continue BCPAP therapy for the next 6 hours
- •Infant is stable for >4 hours on a BCPAP pressure of 6 cmH2O and 6 L/min with no oxygen requirement, with a respiratory rate of <60 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 BCPAP.
- •Prenatal asphyxia (Apgar score less than 3 at minute 5, Cord pH less than 7, and cord bicarbonate less than 12)
- •Infants with notifiable diseases.
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