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Population Pharmacokinetics and Metabolomics of Theophylline in Preterm Infants

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Apea of Prematurity

Phase: N/A

Status: Enrolling by invitation

Sponsored by: Seoul National University Hospital

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

Clinical Details

Official title: Population Pharmacokinetics and Metabolomic Analysis of Aminopylline/Theophylline Drug Levels in Preterm Infants With Apnea of Prematurity

Study design: Observational Model: Cohort, Time Perspective: Prospective

Eligibility

Minimum age: N/A. Maximum age: 37 Weeks. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: May 2010
Last updated: February 21, 2012

Page last updated: August 23, 2015

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