Population Pharmacokinetics and Metabolomics of Theophylline in Preterm Infants

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01509248

Enrollment

110

Registered

2012-01-12

Start date

2010-05-31

Completion date

Unknown

Last updated

2012-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apea of Prematurity

Keywords

Theophylline

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 37 Weeks

Healthy volunteers

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

Outcome results