跳至主要内容
临床试验/EUCTR2015-002470-20-SE
EUCTR2015-002470-20-SE进行中(未招募)1 期

Fentanyl and Clonidine for analgesia during hypothermia in term asphyxiated infants – a prospective pharmacokinetic/ pharmacodynamic/ pharmacogenetic observational study. Cohort 1 in The SANNI project.

Skåne University Hospital0 个研究点目标入组 50 人开始时间: 2017年1月30日最近更新:

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
50

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

  • Term infants who, according to national guidelines, will receive hypothermic treatment following perinatal asphyxia, and are in need for analgesic or sedative medication according to clinical judgment based on Thomsons score and ALPS-Neo.
  • Existing arterial or venous cannulas/catheters for repeated non-traumatic blood sampling
  • Informed and written parental consent;
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 50
  • 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

  • AV- block I-III or HR < 70 – same as for hypothermia.
  • Serious CHD with need for postnatal surgery – same as for hypothermia
  • MABP <35 mmHg despite adequate treatment.

研究者

发起方
Skåne University Hospital

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