Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Children With PDA
1 other identifier
observational
500
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2020
CompletedFirst Posted
Study publicly available on registry
May 21, 2020
CompletedStudy Start
First participant enrolled
May 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 6, 2023
CompletedMay 21, 2020
May 1, 2020
2.7 years
May 18, 2020
May 20, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (1)
Adverse events
Through study completion, an average of 3 days
Study Arms (1)
Treatment(paracetamol or ibuprofen)
Paracetamol and ibuprofen are administered at standard dose for children with PDA.
Interventions
10 mg/kg qd for the 1st day, 5 mg/kg qd for the 2nd and 3rd day
Eligibility Criteria
Neonates with patent ductus arteriosus
You may qualify if:
- 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.
You may not qualify if:
- Patients who die within the treatment cycle;
- Patients with other heart diseases;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shandong Universitylead
- West China Second University Hospitalcollaborator
Study Sites (1)
West China Second University Hospital
Chengdu, Sichuan, 610041, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor; Head of department of clinical pharmacy and pharmacology
Study Record Dates
First Submitted
May 18, 2020
First Posted
May 21, 2020
Study Start
May 25, 2020
Primary Completion
January 30, 2023
Study Completion
May 6, 2023
Last Updated
May 21, 2020
Record last verified: 2020-05