Cefazolin Pharmacokinetics: Elimination Clearance in Neonates
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Pharmacokinetics of iv cefazolin in neonates
研究概览
简要总结
To document cefazolin disposition (concentration/time profile, protein binding, metabolism, renal elimination characteristics) and its covariates in neonates following intravenous administration of the drug at induction of anesthesia, prior to an invasive procedure
To evaluate if optimalisation of cefazolin dose regimen during neonatal life is needed
详细描述
Prospective, single-center, open label study on the pharmacokinetics of iv cefazolin administration in neonates admitted in the neonatal intensive care unit, University Hospitals Leuven, Belgium.
Patients will be included after signed informed consent of the parents.
Our aim is to include 40 neonates. Cefazolin has been selected for this study as it is routinely administered in neonates undergoing invasive procedures in our unit. At this stage, we only have the intention to document pharmacokinetics and covariates based on the current clinical practice and therefore will not interfere with either clinical indication, or with dosing as prescribed by the attending physician.
Drug administration and collection of samples will be obtained to the current clinical and nursing standard procedures.
Routine clinical care for scheduled invasive procedures in neonates in our unit is intravenous administration of cefazolin as follows:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed parental informed written consent
- •neonates to whom cefazolin is administered by intravenous route for clinical indications (invasive procedure)
排除标准
- •known cefazolin intolerance
研究组 & 干预措施
Cefazolin, antibiotic prophylaxis
All included patients will received iv cefazolin
干预措施: Cefazolin (Drug)
结局指标
主要结局
Pharmacokinetics of iv cefazolin in neonates
时间窗: up to 24 h following the first dose administration (in surgical procedures with forein-body implantation up to 48 h following the first dose administration)
次要结局
- Optimalisation of cefazolin dose regimen during neonatal life(up to 24 h following the first dose administration (in surgical procedures with forein-body implantation up to 48 h following the first dose administration))