Apea of Prematurity Clinical Trial
Official title:
Population Pharmacokinetics and Metabolomic Analysis of Aminopylline/Theophylline Drug Levels in Preterm Infants With Apnea of Prematurity
| Verified date | February 2012 |
| Source | Seoul National University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Institutional Review Board |
| Study type | Observational |
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
| Status | Enrolling by invitation |
| Enrollment | 110 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 37 Weeks |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Seoul National University Hospital | Korea University Anam Hospital, Seoul National University Boramae Hospital, Seoul National University Bundang Hospital |