ISRCTN24569018已完成未知
A multi-centre clinical study to evaluate the use of a microtrace dose of 14C-labelled paracetamol and Accelerator Mass Spectrometry (AMS) bioanalysis as new tools in drug development to determine pharmacokinetics in neonates, infants and toddlers
iverpool Women's NHS Foundation Trust (UK)0 个研究点目标入组 60 人开始时间: 2012年11月27日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Infants and toddlers from preterm neonates (32-36 GW at birth) up to 2 years of age
- •2. Having intravenous or intra-arterial access suitable for blood sampling
- •3. Written informed consent prior to any study-specific procedures
- •4. Able to tolerate oral administration for oral administration group
排除标准
- •1. History of allergy or hypersensitivity to paracetamol;
- •2. Serious hepatic and/or renal impairment defined as creatinine > 150 micromol or AST or ALT > 200
- •3. Be otherwise unsuitable for the study, in the opinion of the investigator
- •4. Extracorporeal membrane oxygenation (ECMO)
- •5. Haemofiltration, peritoneal dialysis, haemodialysis
研究者
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