EUCTR2017-005091-26-SE进行中（未招募）1 期
Clonidine for analgesia to preterm infants during neonatal intensive care – a prospective pharmacokinetic/pharmacodynamic/pharmacogenetic observational study. Cohort 2 in The SANNI project.
Skåne University Hospital0 个研究点目标入组 100 人开始时间: 2017年12月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
- •Preterm infants (< gw 37+0) who are in need for analgesic or sedative medication according to clinical judgment (scoring with pain assessment scales; ALPS-Neo and Comfort-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: 100
- •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
- •Hemodynamic instability (same as in clinical routine).
- •Cardiac malformations in need for postnatal surgery.
- •Any serious medical condition or ethical issues that could, in the Investigators opinion, interfere with the study procedures.
研究者
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