Population Pharmacokinetics and Dosage Individualization of Bosentan, Sildenafil and Tadalafil in Persistent Pulmonary Hypertension of the Newborn
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
- The change of hemodynamics
研究概览
简要总结
The use of bosentan, sildenafil and tadalafil in neonates with persistent pulmonary hypertension (PPHN) depends mostly on the empirical experience of pediatricians. Moreover, the recommended dose of those three drugs in treating PPHN remains controversial. Therefore, our aim is to study the pharmacokinetics and pharmacodynamics of bosentan, sildenafil and tadalafil in neonates of PPHN then dose a tailor-made therapeutic regimen.
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
- •Age: postnatal age ≤ 28 days;
- •Patients have been diagnosed with PPHN;
- •Bosentan, sildenafil and/or tadalafil used as part of regular treatment.
- •Parental written consent
排除标准
- •Expected survival time less than the treatment cycle;
- •Major congenital malformations;
- •Undergoing surgery within the first week of life;
- •Receiving other systemic trial drug therapy;
- •Other factors that the researcher considers unsuitable for inclusion.
研究组 & 干预措施
Treatment(bosentan, sildenafil and tadalafil)
干预措施: Bosentan Tablets (Drug)
Treatment(bosentan, sildenafil and tadalafil)
干预措施: Sildenafil Tablet (Drug)
Treatment(bosentan, sildenafil and tadalafil)
干预措施: Tadalafil Tablets (Drug)
结局指标
主要结局
The change of hemodynamics
时间窗: Through study completion, an average of 5 days
* Pulmonary artery pressure (mmHg) * Alveolar-arterial gradient (mmHg)
Oxygenation index
时间窗: The first 72 hours of the initial treatment
Oxygenation index=(fraction of inspired oxygen\*mean airway pressure)/the partial pressure of arterial oxygen
次要结局
- Sequelae of PPHN(Through study completion and a 6-month visit)
- Pulse oxygen saturation(The first 72 hours of the initial treatment)
- Duration of hospitalization(Within the first 28 days of patients' life)
- Death(Within the first 28 days of patients' life)
- Adverse events(Through study completion, an average of 5 days)
- The need of extra support(Through study completion, an average of 5 days)
研究者
Wei Zhao
Head of department of clinical pharmacy and pharmacology
Shandong University