NCT02426463

Clinical Trial on Individual Characteristics Affecting Pain Drug Therapy in Neonates

Individualising Drug Therapy in Neonates Using Pharmacogenomic Profiling, Population Based Modeling and Simulations

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Turku University Hospital · Other Government
• Sex: All
• Age: 24 Weeks – 40 Weeks
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Critical Illness

Interventions

Type	Name	Description
DRUG	propofol
DRUG	oxycodone

Timeline

• Start date: 2015-04-20
• Primary completion: 2017-02-28
• Completion: 2019-01-31
• First posted: 2015-04-27
• Last updated: 2019-02-04

Locations

1 site across 1 country: Finland