Apea of PrematurityNCT01509248
Population Pharmacokinetics and Metabolomics of Theophylline in Preterm Infants
An observational study of Apea of Prematurity, run by Seoul National University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 37 weeks
- Conditions the study is for
- Apea of Prematurity
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- May 2010to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 37 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Admitted to Neonatal Intensive Care Unit
Who may be able to join
- Inborn preterm infants (GA < 37 weeks)
- Dx : Apnea of prematurity
- Tx : Aminophylline / Theophylline
- Informed consent of parents
Who cannot join
- Major congenital anomaly
- Expired within 72 hours
- Proven secondary apnea
About this study
Official title: 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
- Conditions
- Apea of Prematurity
- Keywords
- Theophylline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Apea of PrematurityStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Seoul National University Boramae Hospital, Korea University Anam Hospital
- Responsible party
- Principal investigator, Han-Suk Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509248
- Sponsor's protocol ID
- TP-PopPK-Metabol
- Status last verified
- Feb 2012
- First submitted
- 9 Jan 2012
- Last updated
- 23 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23666573
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetics and Metabolomic Analysis of Aminopylline/Theophylline Drug Levels in Preterm Infants With Apnea of Prematurity
- ClinicalTrials.gov ID
- NCT01509248
- Acronym / sponsor ID
- TP-PopPK-Metabol
- Conditions
- Apea of Prematurity
- Keywords
- Theophylline
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Seoul National University Boramae Hospital, Korea University Anam Hospital
- Study start
- May 2010
- First posted
- 12 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Admitted to Neonatal Intensive Care Unit
Key inclusion criteria (4 listed)
- Inborn preterm infants (GA < 37 weeks)
- Dx : Apnea of prematurity
- Tx : Aminophylline / Theophylline
- Informed consent of parents
Key exclusion criteria (3 listed)
- Major congenital anomaly
- Expired within 72 hours
- Proven secondary apnea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2012.
- Derived from this study: PubMed 23666573Kim 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Apea of Prematurity, run by Seoul National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01509248, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2012.