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Clinical Trials/NCT01509248
NCT01509248
Unknown
Not Applicable

Population Pharmacokinetics and Metabolomic Analysis of Aminopylline/Theophylline Drug Levels in Preterm Infants With Apnea of Prematurity

Seoul National University Hospital0 sites110 target enrollmentMay 2010
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ConditionsApea of Prematurity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Apea of Prematurity
Sponsor
Seoul National University Hospital
Enrollment
110
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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.

  2. 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
Registry
clinicaltrials.gov
Start Date
May 2010
End Date
TBD
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Han-Suk Kim

Associate Professor & Director of Neonatal Intensive Care Unit

Seoul National University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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