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

Patent Ductus Arteriosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04397913
• Other study ID #: 2020paracetamol-ibuprofen001
• Status: Recruiting
• Start date: May 25, 2020
• Est. completion date: May 6, 2023

Study information

• Verified date: May 2020
• Source: Shandong University
• Contact: Wei Zhao, Ph.D
• Phone: 053188383308
• Email: zhao4wei2[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 6, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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.

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus

Intervention

Drug:
• Paracetamol
15 mg/kg, q6h
• Ibuprofen
10 mg/kg qd for the 1st day, 5 mg/kg qd for the 2nd and 3rd day

Locations

Country	Name	City	State
China	West China Second University Hospital	Chengdu	Sichuan

Sponsors (2)

Lead Sponsor	Collaborator
Shandong University	West China Second University Hospital

Country where clinical trial is conducted

China, 

Outcome

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