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临床试验/EUCTR2018-002876-41-FR
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

发起方
CHU Grenoble-Alpes

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