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Population Pharmacokinetics and Metabolomics of Theophylline in Preterm Infants

Sponsor
Seoul National University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01509248
Collaborator
Seoul National University Bundang Hospital (Other), Seoul National University Boramae Hospital (Other), Korea University Anam Hospital (Other)
110
Enrollment

Study Details

Study Description

Brief Summary

  1. Population pharmacokinetics : The purpose of this study is
  • to investigate the population pharmacokinetics of theophylline in premature Korean infants and to assess the influence of demographic and clinical covariates.
  1. Metabolomics : The purpose of this study are

  • to predict serum theophylline levels and to assess CYP1A2 activities in premature infants by analyzing urinary metabolites of theophylline

  • to examine which factors affect clearance of theophylline and CYP1A2 activity in premature infants

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    110 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Population Pharmacokinetics and Metabolomic Analysis of Aminopylline/Theophylline Drug Levels in Preterm Infants With Apnea of Prematurity
    Study Start Date :
    May 1, 2010

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A to 37 Weeks
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      • Inborn preterm infants (GA < 37 weeks)

      • Dx : Apnea of prematurity

      • Tx : Aminophylline / Theophylline

      • Informed consent of parents

      Exclusion Criteria:

      • Major congenital anomaly

      • Expired within 72 hours

      • Proven secondary apnea

      Contacts and Locations

      Locations

      No locations specified.

      Sponsors and Collaborators

      • Seoul National University Hospital
      • Seoul National University Bundang Hospital
      • Seoul National University Boramae Hospital
      • Korea University Anam Hospital

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Han-Suk Kim, Associate Professor & Director of Neonatal Intensive Care Unit, Seoul National University Hospital
      ClinicalTrials.gov Identifier:
      NCT01509248
      Other Study ID Numbers:
      • TP-PopPK-Metabol
      First Posted:
      Jan 12, 2012
      Last Update Posted:
      Feb 23, 2012
      Last Verified:
      Feb 1, 2012
      Keywords provided by Han-Suk Kim, Associate Professor & Director of Neonatal Intensive Care Unit, Seoul National University Hospital
      Theophylline
      Additional relevant MeSH terms:
      Premature Birth

      Study Results

      No Results Posted as of Feb 23, 2012