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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04397913

Enrollment

500

Registered

2020-05-21

Start date

2020-05-25

Completion date

2023-05-06

Last updated

2020-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patent Ductus Arteriosus

Brief summary

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.

Interventions

DRUGParacetamol

15 mg/kg, q6h

DRUGIbuprofen

10 mg/kg qd for the 1st day, 5 mg/kg qd for the 2nd and 3rd day

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 28 Days

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.

Design outcomes

Primary

Measure	Time frame	Description
Plasma drug concentration of paracetamol	at (0-1) hour, (1-3) hours, (3-5) hours, (5-6) hours after oral administration	To detect the plasma concentration of paracetamol after administration
Plasma drug concentration of ibuprofen	at (0-1.5) hours, (1-4) hours, (4-12) hours,(12-24) hours after oral administration	To detect the plasma concentration of ibuprofen after administration
Echocardiography	Through study completion, an average of 3 days	To measure arterial duct diameter, shunt speed and direction of shunt
Cardiac function	Through study completion, an average of 3 days	To detect brain natriuretic peptide(BNP) and troponin T(cTnT)

Secondary

Measure	Time frame	Description
Adverse events	Through study completion, an average of 3 days	Drug-related adverse events and serious adverse events

Countries

China

Contacts

Primary ContactWei Zhao, Ph.D

zhao4wei2@hotmail.com053188383308

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026