Clinical Trial on Individual Characteristics Affecting Pain Drug Therapy in Neonates

Critical Illness Clinical Trial

— NeoPopGen  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02426463
• Other study ID #: T65/2015
• Status: Completed
• Phase: Phase 4
• Start date: April 20, 2015
• Est. completion date: January 31, 2019

Study information

• Verified date: February 2019
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 31, 2019
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Weeks to 40 Weeks

Eligibility

Inclusion Criteria:

• Given informed consent by the guardian of an eligible patient.

• Patient is more than 24 weeks old and has a body weight more than 500 g.

• Patient needs intensive care treatment based on a clinical decision by a neonatologist and receives propofol or oxycodone on their therapy. Attending neonatologist makes the decision to prescribe propofol for scheduled short procedural sedation or oxycodone for analgesia as well as all other treatment related decisions.

Exclusion Criteria:

• Eligible patients guardian declines to give informed consent.

• A previous history of intolerance to the study drugs or to related compounds and additives.

• History of any kind of drug allergy.

• Participation in any other studies concomitantly or within one month prior to the entry into this study.

Related Conditions & MeSH terms

• Critical Illness

Intervention

Drug:
• propofol

• oxycodone

Locations

Country	Name	City	State
Finland	Department of Paediatrics and Adolescent Medicine, Turku University Hospital	Turku

Sponsors (3)

Lead Sponsor	Collaborator
Turku University Hospital	Helsinki University, University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration versus time curve (AUC) of propofol and oxycodone.	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.	24 hours post-dose.
Secondary	Effect of biometric and genomic covariates on AUC	Covariate analysis and simulations to individualize population models	24 hours post-dose
Secondary	Efficacy of propofol in procedural anesthesia in neonates	Number of Participants with Adverse Events as a Measure of Safety and Tolerability during procedural anesthesia for intratracheal intubation in neonates	24 hours
Secondary	Efficacy of oxycodone as an analgesic in neonates during mechanical ventilation	Number of Participants with Adverse Events as a Measure of Safety and Tolerability in neonates after oxycodone administration during mechanical ventilation.	24 hours