Population Pharmacokinetics and Metabolomics of Theophylline in Preterm Infants

• Conditions: Apea of Prematurity

• Registration Number: NCT01509248
• Lead Sponsor: 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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2012-01-09
• Study First Submitted QC: 2012-01-11
• Study First Posted: 2012-01-12
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-21
• Last Update Posted: 2012-02-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Inborn preterm infants (GA < 37 weeks)
• Dx : Apnea of prematurity
• Tx : Aminophylline / Theophylline
• Informed consent of parents

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Exclusion Criteria

• Major congenital anomaly
• Expired within 72 hours
• Proven secondary apnea

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified