Dexmedetomidine for Analgosedation to Newborn Infants During Neonatal Intensive Care - a Prospective Pharmacokinetic/ Pharmacodynamic/ Pharmacogenetic Observational Study.Cohort 3 in The SANNI Project.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Region Skane
- 试验地点
- 2
- 主要终点
- Pharmacokinetics (PK) of dexmedetomidine
研究概览
简要总结
A prospective pharmacokinetic (PK), pharmacodynamic (PD) and pharmacogenetic (PG) observation study, including the PK/PD/PG relationship, on dexmedetomidine administered for analgesia and sedation to postsurgical and other newborn sick infants needing the drug for clinical reasons during neonatal intensive care. Phase III - therapeutic confirmatory study.
详细描述
The patients will be treated according to clinical guidelines and judgement as decided by the responsible clinical doctor.
The dosing and administration of dexmedetomidine will be implemented according to an algorithm based on pain scoring results.
Apart from extra blood sampling and extended bedside monitoring for amplitude-integrated EEG (aEEG), Near InfraRed Spectroscopy (NIRS), and Galvanic Skin Response (GSR) the care is according to clinical routine.
In total 100 infants will be included.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 27 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
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 intensive care unit) and in a some few cases in the NICU (neonatal intensive care unit), or
- •with a corresponding age of 37 gw, who are in need for dexmedetomidine according to clinical judgment and cared for in the NICU.
- •Existing arterial or venous cannulas/catheters for repeated nontraumatic blood sampling
- •Informed and written parental consent obtained before study start.
排除标准
- •Infant older than age corresponding to gw 46+0
- •Previous treatment with the dexmedetomidine 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.
研究组 & 干预措施
dexmedetomidine
Infusion of dexmedetomidine 4 microgram/mL.
干预措施: dexmedetomidine (Drug)
结局指标
主要结局
Pharmacokinetics (PK) of dexmedetomidine
时间窗: Repeated blood samples (5 minutes after the loading dose until 12 hours after stop of infusion)
The plasma concentration will be analysed and then further reported using NONMEM® (Non-linear Mixed Effect Modelling) population-based PK modelling.
Neurophysiologic response; global brain network function in relation to PK
时间窗: Baseline until 12 hours after stop of infusion
Assessment of global brain network function will be based on Activation Synchrony Index.
次要结局
- Change in mean arterial blood pressure, MABP, (hemodynamic response) in relation to PK (PK/PD)(Baseline until 12 hours after stop of infusion)
- Procedural pain response in relation to PK: assessed with change in galvanic skin response(Once during treatment with dexmedetomidine)
- Change in heart rate, HR, (hemodynamic response) in relation to PK (PK/PD)(Baseline until 12 hours after stop of infusion)
- Change in/association between Near Infrared spectroscopy, NIRS, in relation to PK.(Once per second (from baseline until 12 hours after stop of infusion))