ACTRN12606000264583进行中(未招募)1 期
Randomised controlled trial of headbox oxygen versus Continuous Positive Airways Pressure (CPAP) to reduce up-transfer of infants with respiratory distress in non-teritary hospitals.
Adam Buckmaster0 个研究点目标入组 300 人开始时间: 2003年1月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 300
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
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- ot stated 至 31 Weeks(—)
- 性别
- All
入选标准
- •1. dagnosed with respiratory distress. Defined as al least one of the following: recession, grunt, nasal flare, or tachypnoea (respiratory rate >60/minute)2. Who require >30% oxygen to maintain SaO2 or> or = 94% over a period of >30minutes.3. Babies aged less than 24 hours
排除标准
- •1. Infants < 31wks gestation. 2. Infants <1200 grams. Corresponds to the 10th percentile for 31 weeks gestation. 3. Apgar score = 3 at 5minutes of age. Used as an arbitrary and de-facto indicator of possible perinatal asphyxia.4. Cardiac cause of respiratory distress. 5. Any infant who is perceived by their paediatrician to need NICU care. This out clause” will provide an added safety mechanism and will cover infants with, for example, congenital anomalies. Potential implications for generalisability will be assessed by recording non-identifying details of all infants excluded for this reason, along with the reason for transfer.
研究者
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