EUCTR2018-002876-41-FR进行中(未招募)1 期
Assesment of Propofol sedation during intra tracheal surfactant administration by the LISA method (Less Invasive Surfactant Administration) - PROLISA
CHU Grenoble-Alpes0 个研究点目标入组 542 人开始时间: 2018年8月8日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 542
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- Preterm Infants < 32 wGA
- •- Presenting a RDS
- •in the first 48 hours of life
- •treated by CPAP
- •requiring surfactant :
- •if 28 - 31 SA : FiO2 =30% for a duration = 10mn
- •if <28 SA FIO2 =25% for a duration =10mn
- •To obtain a SaO2 between =88 and = 95%
- •- Available Intra-Venous line
- •- Covered by French Social Security
- •- Informed consent form signed
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 542
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Congenital and/or major malformations
- •- FIO2> 60%
- •- Silverman score> at 6
- •- Low Blood Pressure with 2 successive measurements (Mean < Gestational Age expressed in Weeks of Gestation) persisting after one volume expansion
- •- Use of inotropic medication to maintain normal blood pressure.
- •- Use of sedative or analgesic drugs (except paracetamol and ibuprofen) in the previous 24h
研究者
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