ClinicalTrials.Veeva

Menu

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

S

Shandong University

Status

Unknown

Conditions

Patent Ductus Arteriosus

Treatments

Drug: Ibuprofen
Drug: Paracetamol

Study type

Observational

Funder types

Other

Identifiers

NCT04397913
2020paracetamol-ibuprofen001

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

Under 28 days old

Volunteers

No Healthy Volunteers

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.

Trial design

500 participants in 1 patient group

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

Trial contacts and locations

1

Loading...

Central trial contact

Wei Zhao, Ph.D

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems