Brief Title
Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Children With PDA
Official Title
Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Preterm Neonates and Infants With Patent Ductus Arteriosus
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.
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
Primary Outcome
Plasma drug concentration of paracetamol
Secondary Outcome
Adverse events
Condition
Patent Ductus Arteriosus
Intervention
Paracetamol
Study Arms / Comparison Groups
Treatment(paracetamol or ibuprofen)
Description: Paracetamol and ibuprofen are administered at standard dose for children with PDA.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
500
Start Date
May 25, 2020
Completion Date
May 6, 2023
Primary Completion Date
January 30, 2023
Eligibility Criteria
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.
Gender
All
Ages
N/A - 28 Days
Accepts Healthy Volunteers
No
Contacts
, 053188383308, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04397913
Organization ID
2020paracetamol-ibuprofen001
Responsible Party
Principal Investigator
Study Sponsor
Shandong University
Collaborators
West China Second University Hospital
Study Sponsor
, ,
Verification Date
May 2020