Population Pharmacokinetics and Metabolomics of Theophyll... | NCT01509248

Studies
Population Pharmacokinetics and Metabolomics of Theophylline in Preterm Infants

NCT01509248

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Feb 23, 2012Estimated

Enrollment

110Estimated

Phase

Not provided

Conditions

Apea of Prematurity

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jan 9, 2012

First Submission Date that Met QC Criteria

Jan 11, 2012

First Posted Date

Jan 12, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2012

Last Update Posted Date

Feb 23, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Han-Suk Kim, Associate Professor & Director of Neonatal Intensive Care Unit, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Name	Class
Seoul National University Bundang Hospital	OTHER
Seoul National University Boramae Hospital	OTHER
Korea University Anam Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

110Estimated

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

37 Weeks

Standard Ages

Child

Study Population

Admitted to Neonatal Intensive Care Unit

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23666573	Derived	Kim SE, Kim BH, Lee S, Sohn JA, Kim HS, Cho JY, Yoon SH, Jang IJ, Yu KS, Lim KS. Population pharmacokinetics of theophylline in premature Korean infants. Ther Drug Monit. 2013 Jun;35(3):338-44. doi: 10.1097/FTD.0b013e3182866695.