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

Sponsor
Shandong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04397913
Collaborator
West China Second University Hospital (Other)
500
Enrollment
1
Location
35.4
Anticipated Duration (Months)
14.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Preterm Neonates and Infants With Patent Ductus Arteriosus
Anticipated Study Start Date :
May 25, 2020
Anticipated Primary Completion Date :
Jan 30, 2023
Anticipated Study Completion Date :
May 6, 2023

Arms and Interventions

Arm 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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    3. Echocardiography [Through study completion, an average of 3 days]

      To measure arterial duct diameter, shunt speed and direction of shunt

    4. Cardiac function [Through study completion, an average of 3 days]

      To detect brain natriuretic peptide(BNP) and troponin T(cTnT)

    Secondary Outcome Measures

    1. Adverse events [Through study completion, an average of 3 days]

      Drug-related adverse events and serious adverse events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 28 Days
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 West China Second University Hospital Chengdu Sichuan China 610041

    Sponsors and Collaborators

    • Shandong University
    • West China Second University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wei Zhao, Professor; Head of department of clinical pharmacy and pharmacology, Shandong University
    ClinicalTrials.gov Identifier:
    NCT04397913
    Other Study ID Numbers:
    • 2020paracetamol-ibuprofen001
    First Posted:
    May 21, 2020
    Last Update Posted:
    May 21, 2020
    Last Verified:
    May 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Ductus Arteriosus, Patent
    Acetaminophen
    Ibuprofen

    Study Results

    No Results Posted as of May 21, 2020