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

  • STATUS
    Recruiting
  • participants needed
    500
  • sponsor
    Shandong University
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Updated on 16 February 2024
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ibuprofen
patent ductus arteriosus

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.

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.

Details
Condition Congenital Heart Defect, Congenital Heart Disease, Patent ductus arteriosus, Congenital Heart Disease
Age 1years or below
Treatment Paracetamol, Ibuprofen
Clinical Study IdentifierNCT04397913
SponsorShandong University
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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