Population Pharmacokinetics and Metabolomics of Theophylline in Preterm Infants

Seoul National University

Status: Unknown

Conditions: Apea of Prematurity

Study type: Observational

Funder types: Other

Identifiers

NCT01509248

TP-PopPK-Metabol

Details and patient eligibility

About

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

Enrollment: 110 estimated patients

Sex: All

Ages: Under 37 weeks old

Volunteers: No 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