Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Children With PDA

Study Overview
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Brief Summary
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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
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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.

Official Title
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Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Preterm Neonates and Infants With Patent Ductus Arteriosus

Conditions
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Patent Ductus Arteriosus

Intervention / Treatment
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* Drug: Paracetamol
* Drug: Ibuprofen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Patients who die within the treatment cycle; Patients with other heart diseases; Other factors that the researcher considers unsuitable for inclusion.

Ages Eligible for Study
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Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment(paracetamol or ibuprofen)<br>Paracetamol and ibuprofen are administered at standard dose for children with PDA. | Drug: Paracetamol<br>* 15 mg/kg, q6h<br>* Other names: Acetaminophen;Drug: Ibuprofen<br>* 10 mg/kg qd for the 1st day, 5 mg/kg qd for the 2nd and 3rd day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma drug concentration of paracetamol | To detect the plasma concentration of paracetamol after administration | 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 | 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 | Through study completion, an average of 3 days | 
| Cardiac function | To detect brain natriuretic peptide(BNP) and troponin T(cTnT) | Through study completion, an average of 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Drug-related adverse events and serious adverse events | Through study completion, an average of 3 days |