Individualising Drug Therapy in Neonates Using Pharmacogenomic Profiling, Population Based Modeling and Simulations
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve (AUC) of propofol and oxycodone.
研究概览
简要总结
Children differ from adults with respect to growth and development but also immaturity of various pharmacological mechanisms. Dosing schemes in children are usually derived in an empirical manner from clinical trials in adult patient groups. All this poses neonates to an increased risk for therapeutic failure and adverse drug reactions.
Medicinal products studied during this project are among the ones with the highest needs for research in the pediatric intensive care. This project focuses on the necessity to integrate subject's individual characteristics to assist clinical decision-making in drug therapy. The investigators explore the mechanisms defining the dose response in pediatric populations. The results obtained with these studies will help to find safer drug dosing regimens in this delicate patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 24 Weeks 至 40 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Given informed consent by the guardian of an eligible patient.
- •Patient is more than 24 weeks old and has a body weight more than 500 g.
- •Patient needs intensive care treatment based on a clinical decision by a neonatologist and receives propofol or oxycodone on their therapy. Attending neonatologist makes the decision to prescribe propofol for scheduled short procedural sedation or oxycodone for analgesia as well as all other treatment related decisions.
排除标准
- •Eligible patients guardian declines to give informed consent.
- •A previous history of intolerance to the study drugs or to related compounds and additives.
- •History of any kind of drug allergy.
- •Participation in any other studies concomitantly or within one month prior to the entry into this study.
研究组 & 干预措施
Propofol
Plasma samples and patient data are collected prospectively from 40 neonates who receive propofol as part of their care in the neonatal intensive care unit at the Turku University Hospital, Turku, Finland.
干预措施: propofol (Drug)
Oxycodone
Plasma samples and patient data are collected prospectively from 40 neonates who receive oxycodone as part of their care in the neonatal intensive care unit at the Turku University Hospital, Turku, Finland.
干预措施: oxycodone (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC) of propofol and oxycodone.
时间窗: 24 hours post-dose.
Primary outcome is to build up a population pharmacometric model to describe pharmacokinetics of propofol and oxycodone based on drug concentrations analyzed from the plasma samples.
次要结局
- Effect of biometric and genomic covariates on AUC(24 hours post-dose)
- Efficacy of propofol in procedural anesthesia in neonates(24 hours)
- Efficacy of oxycodone as an analgesic in neonates during mechanical ventilation(24 hours)