Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Preterm Neonates and Infants With Patent Ductus Arteriosus
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Plasma drug concentration of paracetamol
研究概览
简要总结
The investigator's purpose is to study the population pharmacokinetics of paracatamol and ibuprofen in neonates with patent ductus arteriosus (PDA) and assess the feasibility of dosage individualization.
详细描述
The investigator's purpose is to study the population pharmacokinetics of paracatamol and ibuprofen in neonates with patent ductus arteriosus (PDA) and assess the feasibility of dosage individualization. In this study, the investigator will detect drug concentration in plasma and other clinical test to construct population pharmacokinetic models.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients have been diagnosed with PDA;
- •Age: postnatal age ≤ 28 days;
- •Paracetamol or ibuprofen used as part of regular treatment;
- •Paracetamol or ibuprofen was administered orally.
排除标准
- •Patients who die within the treatment cycle;
- •Patients with other heart diseases;
- •Other factors that the researcher considers unsuitable for inclusion.
研究组 & 干预措施
Treatment(paracetamol or ibuprofen)
Paracetamol and ibuprofen are administered at standard dose for children with PDA.
干预措施: Paracetamol (Drug)
Treatment(paracetamol or ibuprofen)
Paracetamol and ibuprofen are administered at standard dose for children with PDA.
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Plasma drug concentration of paracetamol
时间窗: at (0-1) hour, (1-3) hours, (3-5) hours, (5-6) hours after oral administration
To detect the plasma concentration of paracetamol after administration
Plasma drug concentration of ibuprofen
时间窗: at (0-1.5) hours, (1-4) hours, (4-12) hours,(12-24) hours after oral administration
To detect the plasma concentration of ibuprofen after administration
Echocardiography
时间窗: Through study completion, an average of 3 days
To measure arterial duct diameter, shunt speed and direction of shunt
Cardiac function
时间窗: Through study completion, an average of 3 days
To detect brain natriuretic peptide(BNP) and troponin T(cTnT)
次要结局
- Adverse events(Through study completion, an average of 3 days)
研究者
Wei Zhao
Professor; Head of department of clinical pharmacy and pharmacology
Shandong University