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临床试验/EUCTR2005-003516-29-DE
EUCTR2005-003516-29-DE进行中(未招募)不适用

Prospective, randomized, double-blinded clinical trial on remifentanil for analgesia and sedation of ventilated neonates and infants - RAPIP-Pilotstudie

niversität zu Köln0 个研究点开始时间: 2006年10月20日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

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

性别
All

入选标准

  • Ventilated term newborns and infants < 60 days.
  • Expected time of artificial ventilation between 12 and 96 hours.
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range:
  • 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

  • Various conditions of neuromuscular impairment e.g. severe peripartal asphyxia, cerebral infarct, congenital muscular diseases or metabolic defects showing distinct neuromuscular symptoms.
  • Drug abuse of the mother (exclusion criterion for newborns).
  • Known hypersensitivity to Ultiva®, Fentanyl-Janssen® or fentanyle equivalents.
  • Missing informed consent of the parents.
  • Participation in another clinical trial during or within the last 4 weeks before start of this trial.

研究者

发起方
niversität zu Köln

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