ACTRN12621001163897招募中2 期
Oral Doxapram for Apnoea of Prematurity: Dosage Study in Preterm Infants
niversity of Auckland0 个研究点目标入组 32 人开始时间: 2021年8月27日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
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
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 3 Days 至 3 Months（—）
- 性别
- All
入选标准
- •Infants are eligible for this study if they are born at <32 weeks’ gestation, are admitted to neonatal intensive care and meet all of the following criteria:
- •a) Greater than or equal to 72 h old
- •b) Maximum non-invasive respiratory support (bubble nasal CPAP greater than or equal to 8 cmH20)
- •c) Optimised dose of caffeine citrate (greater than or equal to 15 mg/kg/day)
- •d) Evidence of significant apnoea/bradycardia/desaturation events in the past 48 hours, defined as one or more of the following: hypercapnia (PC02 greater than or equal to 8 kPa); hypoxaemia (peripheral oxygen saturation <90% for greater than or equal to 30% of time over greater than or equal to 6 hours; greater than or equal to 1 ABD event requiring positive pressure inflation; greater than or equal to 6 significant desaturations in 6 hours (peripheral oxygen saturation <80% associated with bradycardia <100/min and requiring nursing intervention).
排除标准
- •Current treatment for proven sepsis
- •Recent grade 3-4 intraventricular haemorrhage (<72 hours)
- •Confirmed major congenital malformation or chromosomal disorder
- •Previous use of doxapram
- •Use of respiratory stimulant other than caffeine citrate
- •Previous seizure
研究者
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