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.
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.
Study Type
OBSERVATIONAL
Enrollment
500
15 mg/kg, q6h
10 mg/kg qd for the 1st day, 5 mg/kg qd for the 2nd and 3rd day
West China Second University Hospital
Chengdu, Sichuan, China
RECRUITINGPlasma drug concentration of paracetamol
To detect the plasma concentration of paracetamol after administration
Time frame: at (0-1) hour, (1-3) hours, (3-5) hours, (5-6) hours after oral administration
Plasma drug concentration of ibuprofen
To detect the plasma concentration of ibuprofen after administration
Time frame: at (0-1.5) hours, (1-4) hours, (4-12) hours,(12-24) hours after oral administration
Echocardiography
To measure arterial duct diameter, shunt speed and direction of shunt
Time frame: Through study completion, an average of 3 days
Cardiac function
To detect brain natriuretic peptide(BNP) and troponin T(cTnT)
Time frame: Through study completion, an average of 3 days
Adverse events
Drug-related adverse events and serious adverse events
Time frame: Through study completion, an average of 3 days
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