Status:

UNKNOWN

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

Lead Sponsor:

Shandong University

Collaborating Sponsors:

West China Second University Hospital

Conditions:

Patent Ductus Arteriosus

Eligibility:

All Genders

Up to 28 years

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 individualizati...

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 individualizati...

Eligibility Criteria

Inclusion

  • 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

  • Patients who die within the treatment cycle;
  • Patients with other heart diseases;
  • Other factors that the researcher considers unsuitable for inclusion.

Key Trial Info

Start Date :

May 25 2020

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

May 6 2023

Estimated Enrollment :

500 Patients enrolled

Trial Details

Trial ID

NCT04397913

Start Date

May 25 2020

End Date

May 6 2023

Last Update

May 21 2020

Active Locations (1)

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Page 1 of 1 (1 locations)

1

West China Second University Hospital

Chengdu, Sichuan, China, 610041