ACTRN12619000995178招募中3 期
Surfactant administration by either supraglottic airway device (SAD) or direct laryngoscopy in late preterm and term newborns on nasal continuous positive airway pressure (nCPAP): A randomised, multi-centre, non-inferiority trial
Women's and Children's Hospital0 个研究点目标入组 148 人开始时间: 2019年7月12日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 148
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
- Blinded (masking used)
入排标准
- 年龄范围
- o limit 至 24 Hours（—）
- 性别
- All
入选标准
- •Infants are eligible for inclusion in the study if:
- •They are born at >33 weeks GA by best obstetric estimate and have a birth weight of >1500g; and
- •They are <24 hours old at the time of randomisation; and
- •They require nasal continuous positive airway pressure (nCPAP) after admission for moderate-to-severe respiratory distress, hypoxia or hypercapnia where the treating clinician has determined surfactant therapy is indicated and it is felt unlikely ongoing mechanical ventilation is required.
排除标准
- •Infants are excluded from the trial if:
- •They have a known major congenital abnormality that may impact on the infants’ condition (including complex congenital cardiac disease, upper airway obstruction or complex airway abnormality, gastro-intestinal malformation; and
- •They have previously been intubated (including intubation for suctioning below the cords in the delivery suite), or immediately need intubation, as a determined by the attending clinician.
研究者
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