Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Children With PDA
- Conditions
- Patent Ductus Arteriosus
- Interventions
- Registration Number
- NCT04397913
- Lead Sponsor
- Shandong University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 500
- 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.
- Patients who die within the treatment cycle;
- Patients with other heart diseases;
- Other factors that the researcher considers unsuitable for inclusion.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Treatment(paracetamol or ibuprofen) Paracetamol Paracetamol and ibuprofen are administered at standard dose for children with PDA. Treatment(paracetamol or ibuprofen) Ibuprofen Paracetamol and ibuprofen are administered at standard dose for children with PDA.
- Primary Outcome Measures
Name Time Method Plasma drug concentration of paracetamol 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 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 Through study completion, an average of 3 days To measure arterial duct diameter, shunt speed and direction of shunt
Cardiac function Through study completion, an average of 3 days To detect brain natriuretic peptide(BNP) and troponin T(cTnT)
- Secondary Outcome Measures
Name Time Method Adverse events Through study completion, an average of 3 days Drug-related adverse events and serious adverse events
Trial Locations
- Locations (1)
West China Second University Hospital
🇨🇳Chengdu, Sichuan, China