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Population Pharmacokinetics and Metabolomics of Theophylline in Preterm Infants

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Seoul National University Bundang Hospital
Seoul National University Boramae Hospital
Korea University Anam Hospital
Information provided by (Responsible Party):
Han-Suk Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01509248
First received: January 9, 2012
Last updated: February 21, 2012
Last verified: February 2012
History of Changes
  Purpose

  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

Condition
Apea of Prematurity

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies
U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Estimated Enrollment: 110
Study Start Date: May 2010
  Eligibility

Ages Eligible for Study:   up to 37 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Admitted to Neonatal Intensive Care Unit

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Han-Suk Kim, Associate Professor & Director of Neonatal Intensive Care Unit, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01509248     History of Changes
Other Study ID Numbers: TP-PopPK-Metabol
Study First Received: January 9, 2012
Last Updated: February 21, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Theophylline

Additional relevant MeSH terms:
Theophylline
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
 Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013