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

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