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Population Pharmacokinetics and Metabolomics of Theophylline in Preterm Infants

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by Han-Suk Kim, Seoul National University Hospital.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01509248
First Posted: January 12, 2012
Last Update Posted: February 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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:


Further study details as provided by Han-Suk Kim, Seoul National University Hospital:

Estimated Enrollment: 110
Study Start Date: May 2010
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 37 Weeks   (Child)
Sexes Eligible for Study:   All
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: January 9, 2012
First Posted: January 12, 2012
Last Update Posted: February 23, 2012
Last Verified: February 2012

Keywords provided by Han-Suk Kim, Seoul National University Hospital:
Theophylline

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Theophylline
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents