Clinical Trial on Individual Characteristics Affecting Pain Drug Therapy in Neonates (NeoPopGen)

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

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Drug: propofol; Drug: oxycodone

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Finland
  • Turku, Finland, 20521
    • Department of Paediatrics and Adolescent Medicine, Turku University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 9 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: propofol
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.	Drug: oxycodone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of biometric and genomic covariates on AUC	Covariate analysis and simulations to individualize population models	24 hours post-dose
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
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

Collaborators and Investigators

• Sponsor: Turku University Hospital
• Collaborators: University of Turku; University of Helsinki

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2015
• Primary Completion (Actual): February 28, 2017
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: April 13, 2015
• First Submitted That Met QC Criteria: April 24, 2015
• First Posted (Estimate): April 27, 2015

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Neonatal intensive care; need for intratracheal intubation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Propofol; Oxycodone
• Other Study ID Numbers: T65/2015