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

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.

Study Overview

• Status: Recruiting
• Conditions: Patent Ductus Arteriosus
• Intervention / Treatment: Drug: Paracetamol; Drug: Ibuprofen

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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • West China Second University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 weeks (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Neonates with patent ductus arteriosus

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment(paracetamol or ibuprofen); Paracetamol and ibuprofen are administered at standard dose for children with PDA.	Drug: Paracetamol; 15 mg/kg, q6h; Other Names: Acetaminophen; Drug: Ibuprofen; 10 mg/kg qd for the 1st day, 5 mg/kg qd for the 2nd and 3rd day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Echocardiography	To measure arterial duct diameter, shunt speed and direction of shunt	Through study completion, an average of 3 days
Cardiac function	To detect brain natriuretic peptide(BNP) and troponin T(cTnT)	Through study completion, an average of 3 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shandong University
• Collaborators: West China Second University Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 25, 2020
• Primary Completion (ANTICIPATED): January 30, 2023
• Study Completion (ANTICIPATED): May 6, 2023

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (ACTUAL): May 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 21, 2020
• Last Update Submitted That Met QC Criteria: May 20, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Ductus Arteriosus, Patent; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Ibuprofen
• Other Study ID Numbers: 2020paracetamol-ibuprofen001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No