Working… Menu

Population Pharmacokinetics and Metabolomics of Theophylline in Preterm Infants

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. Identifier: NCT01509248
Recruitment Status : Unknown
Verified February 2012 by Han-Suk Kim, Seoul National University Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : January 12, 2012
Last Update Posted : February 23, 2012
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

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

Condition or disease
Apea of Prematurity

Layout table for study information
Study Type : Observational
Estimated 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 2010

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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

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

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Han-Suk Kim, Associate Professor & Director of Neonatal Intensive Care Unit, Seoul National University Hospital Identifier: NCT01509248     History of Changes
Other Study ID Numbers: TP-PopPK-Metabol
First Posted: January 12, 2012    Key Record Dates
Last Update Posted: February 23, 2012
Last Verified: February 2012
Keywords provided by Han-Suk Kim, Seoul National University Hospital:
Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
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