Population Pharmacokinetics and Metabolomics of Theophylline in Preterm Infants
NCT ID: NCT01509248
Last Updated: 2012-02-23
Study Results
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Basic Information
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UNKNOWN
110 participants
OBSERVATIONAL
2010-05-31
Brief Summary
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\- 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
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Dx : Apnea of prematurity
* Tx : Aminophylline / Theophylline
* Informed consent of parents
Exclusion Criteria
* Expired within 72 hours
* Proven secondary apnea
37 Weeks
ALL
No
Sponsors
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Seoul National University Bundang Hospital
OTHER
Seoul National University Boramae Hospital
OTHER
Korea University Anam Hospital
OTHER
Seoul National University Hospital
OTHER
Responsible Party
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Han-Suk Kim
Associate Professor & Director of Neonatal Intensive Care Unit
References
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Kim SE, Kim BH, Lee S, Sohn JA, Kim HS, Cho JY, Yoon SH, Jang IJ, Yu KS, Lim KS. Population pharmacokinetics of theophylline in premature Korean infants. Ther Drug Monit. 2013 Jun;35(3):338-44. doi: 10.1097/FTD.0b013e3182866695.
Other Identifiers
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TP-PopPK-Metabol
Identifier Type: -
Identifier Source: org_study_id
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