Clinical Trial on Individual Characteristics Affecting Pain Drug Therapy in Neonates (NeoPopGen)
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|ClinicalTrials.gov Identifier: NCT02426463|
Recruitment Status : Completed
First Posted : April 27, 2015
Last Update Posted : February 4, 2019
Children differ from adults with respect to growth and development but also immaturity of various pharmacological mechanisms. Dosing schemes in children are usually derived in an empirical manner from clinical trials in adult patient groups. All this poses neonates to an increased risk for therapeutic failure and adverse drug reactions.
Medicinal products studied during this project are among the ones with the highest needs for research in the pediatric intensive care. This project focuses on the necessity to integrate subject's individual characteristics to assist clinical decision-making in drug therapy. The investigators explore the mechanisms defining the dose response in pediatric populations. The results obtained with these studies will help to find safer drug dosing regimens in this delicate patient population.
|Condition or disease||Intervention/treatment||Phase|
|Critical Illness||Drug: propofol Drug: oxycodone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Individualising Drug Therapy in Neonates Using Pharmacogenomic Profiling, Population Based Modeling and Simulations|
|Actual Study Start Date :||April 20, 2015|
|Actual Primary Completion Date :||February 28, 2017|
|Actual Study Completion Date :||January 31, 2019|
Active Comparator: Propofol
Plasma samples and patient data are collected prospectively from 40 neonates who receive propofol as part of their care in the neonatal intensive care unit at the Turku University Hospital, Turku, Finland.
Active Comparator: Oxycodone
Plasma samples and patient data are collected prospectively from 40 neonates who receive oxycodone as part of their care in the neonatal intensive care unit at the Turku University Hospital, Turku, Finland.
- Area under the plasma concentration versus time curve (AUC) of propofol and oxycodone. [ Time Frame: 24 hours post-dose. ]Primary outcome is to build up a population pharmacometric model to describe pharmacokinetics of propofol and oxycodone based on drug concentrations analyzed from the plasma samples.
- Effect of biometric and genomic covariates on AUC [ Time Frame: 24 hours post-dose ]Covariate analysis and simulations to individualize population models
- Efficacy of propofol in procedural anesthesia in neonates [ Time Frame: 24 hours ]Number of Participants with Adverse Events as a Measure of Safety and Tolerability during procedural anesthesia for intratracheal intubation in neonates
- Efficacy of oxycodone as an analgesic in neonates during mechanical ventilation [ Time Frame: 24 hours ]Number of Participants with Adverse Events as a Measure of Safety and Tolerability in neonates after oxycodone administration during mechanical ventilation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426463
|Department of Paediatrics and Adolescent Medicine, Turku University Hospital|
|Turku, Finland, 20521|
|Principal Investigator:||Teijo I Saari, MD, PhD||Dept. Anaesthesiology and Intensive Care, University Of Turku|