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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

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

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

NCT ID

NCT02426463

First Posted

April 13, 2015

Last Updated

February 1, 2019

Sponsor

Turku University Hospital

Collaborators

University of Turku, University of Helsinki

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

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

Arm Title

Oxycodone

Arm Type

Active Comparator

Arm Description

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

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

Learn more about this trial

Clinical Trial on Individual Characteristics Affecting Pain Drug Therapy in Neonates

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