- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01509248
Population Pharmacokinetics and Metabolomics of Theophylline in Preterm Infants
February 21, 2012 updated by: Han-Suk Kim, Seoul National University Hospital
Population Pharmacokinetics and Metabolomic Analysis of Aminopylline/Theophylline Drug Levels in Preterm Infants With Apnea of Prematurity
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.
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
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
110
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 8 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Admitted to Neonatal Intensive Care Unit
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Study Registration Dates
First Submitted
January 9, 2012
First Submitted That Met QC Criteria
January 11, 2012
First Posted (Estimate)
January 12, 2012
Study Record Updates
Last Update Posted (Estimate)
February 23, 2012
Last Update Submitted That Met QC Criteria
February 21, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TP-PopPK-Metabol
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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