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

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Brief Title

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

Official Title

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

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.
    


Study Type

Observational


Primary Outcome

Plasma drug concentration of paracetamol

Secondary Outcome

 Adverse events

Condition

Patent Ductus Arteriosus

Intervention

Paracetamol

Study Arms / Comparison Groups

 Treatment(paracetamol or ibuprofen)
Description:  Paracetamol and ibuprofen are administered at standard dose for children with PDA.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

500

Start Date

May 25, 2020

Completion Date

May 6, 2023

Primary Completion Date

January 30, 2023

Eligibility Criteria

        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.
      

Gender

All

Ages

N/A - 28 Days

Accepts Healthy Volunteers

No

Contacts

, 053188383308, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04397913

Organization ID

2020paracetamol-ibuprofen001


Responsible Party

Principal Investigator

Study Sponsor

Shandong University

Collaborators

 West China Second University Hospital

Study Sponsor

, , 


Verification Date

May 2020