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

Primary Purpose

Critical Illness

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
propofol
oxycodone
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring Neonatal intensive care, need for intratracheal intubation

Eligibility Criteria

24 Weeks - 40 Weeks (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Paediatrics and Adolescent Medicine, Turku University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Propofol

Oxycodone

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Effect of biometric and genomic covariates on AUC
Covariate analysis and simulations to individualize population models
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
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.

Full Information

First Posted
April 13, 2015
Last Updated
February 1, 2019
Sponsor
Turku University Hospital
Collaborators
University of Turku, University of Helsinki
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1. Study Identification

Unique Protocol Identification Number
NCT02426463
Brief Title
Clinical Trial on Individual Characteristics Affecting Pain Drug Therapy in Neonates
Acronym
NeoPopGen
Official Title
Individualising Drug Therapy in Neonates Using Pharmacogenomic Profiling, Population Based Modeling and Simulations
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 20, 2015 (Actual)
Primary Completion Date
February 28, 2017 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Turku University Hospital
Collaborators
University of Turku, University of Helsinki

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
Neonatal intensive care, need for intratracheal intubation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Oxycodone
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
propofol
Intervention Type
Drug
Intervention Name(s)
oxycodone
Primary Outcome Measure Information:
Title
Area under the plasma concentration versus time curve (AUC) of propofol and oxycodone.
Description
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.
Time Frame
24 hours post-dose.
Secondary Outcome Measure Information:
Title
Effect of biometric and genomic covariates on AUC
Description
Covariate analysis and simulations to individualize population models
Time Frame
24 hours post-dose
Title
Efficacy of propofol in procedural anesthesia in neonates
Description
Number of Participants with Adverse Events as a Measure of Safety and Tolerability during procedural anesthesia for intratracheal intubation in neonates
Time Frame
24 hours
Title
Efficacy of oxycodone as an analgesic in neonates during mechanical ventilation
Description
Number of Participants with Adverse Events as a Measure of Safety and Tolerability in neonates after oxycodone administration during mechanical ventilation.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Weeks
Maximum Age & Unit of Time
40 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teijo I Saari, MD, PhD
Organizational Affiliation
Dept. Anaesthesiology and Intensive Care, University Of Turku
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Paediatrics and Adolescent Medicine, Turku University Hospital
City
Turku
ZIP/Postal Code
20521
Country
Finland

12. IPD Sharing Statement

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Clinical Trial on Individual Characteristics Affecting Pain Drug Therapy in Neonates

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