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

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

Recruiting
1 years and younger
All
Phase N/A

Overview

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.

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.

Eligibility

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.

Study details
    Congenital Heart Defect
    Congenital Heart Disease
    Patent ductus arteriosus
    Congenital Heart Disease

NCT04397913

Shandong University

16 February 2024

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