EUCTR2015-002506-37-SE进行中（未招募）1 期
Dexmedetomidine for analgosedation to newborn infants during neonatalintensive care – a prospective pharmacokinetic/ pharmacodynamic/pharmacogenetic observational study.Cohort 3 in The SANNI Project.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Region Skane
- 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
- •Newborn infants
- •- born 34+0 gw with a need for dexmedetomidine for analgesic
- •and/or sedative treatment after postnatal surgical correction of
- •congenital malformations and who will be cared for in the
- •PICU/postoperative unit and in a some few cases in the NICU, or
- •- with a corresponding age of 37 gw, who are in need for
- •dexmedetomidine according to clinical judgment (scoring with pain
- •assessment scales; ALPS-Neo and Comfort-Neo) and cared for in the
- •Existing arterial or venous cannulas/catheters for repeated nontraumatic
- •blood sampling
- •Informed and written parental consent obtained before study start.
- •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
- •Infant older than age corresponding to gw 46+0
- •Previous treatment with the dexmedetomidine or clonidine within 72 hours (only for postoperative infants).
- •Congenital cardiac malformations requiring surgery on extracorporeal circulation and treatment with hypothermia.
- •Ongoing renal replacement treatment
- •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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