ACTRN12620001184965招募中未知
A multi-centre, randomised, controlled, non-inferiority trial in preterm infants with respiratory distress syndrome, comparing surfactant administration by supraglottic airway with minimally invasive surfactant therapy, assessing need for mechanical ventilation or repeat surfactant therapy within 72 hours of randomisation.
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 1,000
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
- o limit 至 48 Hours（—）
- 性别
- All
入选标准
- •Infants are eligible for inclusion in the trial if they meet all of the following criteria:
- •-Born preterm at less than 37 weeks’ gestation
- •-Birth weight 1250 g or above
- •-Age less than 48 hours
- •-Diagnosis of RDS, confirmed with chest x-ray or lung ultrasound, except where treatment is required urgently and would be delayed by imaging
- •-Required FiO2 0.30 or above to maintain target SpO2, on non-invasive respiratory support (CPAP/NIPPV or nHF)
排除标准
- •Infants are excluded from eligibility if they meet any of the following criteria:
- •-Previous treatment with surfactant or mechanical ventilation via an endotracheal tube
- •-Urgent need for intubation and mechanical ventilation as determined by the treating clinician
- •-Urgent need for surfactant prior to eligibility and consent criteria being met
- •-Known pneumothorax
- •-Major congenital anomaly of lungs, heart, or airway
- •-Not receiving full active intensive care (i.e. palliative/comfort care)
研究者
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