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NCT Number: NCT02426463

Clinical Trial on Individual Characteristics Affecting Pain Drug Therapy in Neonates

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.

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

24 week–40 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Paediatrics and Adolescent Medicine, Turku University Hospital

Turku, 20521, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Propofol

Drug

Oxycodone

Drug

Primary outcomes

  1. Area under the plasma concentration versus time curve (AUC) of propofol and oxycodone.

    Time frame: 24 hours post-dose.

    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 outcomes

  1. Effect of biometric and genomic covariates on AUC

    Time frame: 24 hours post-dose

    Covariate analysis and simulations to individualize population models

  2. Efficacy of propofol in procedural anesthesia in neonates

    Time frame: 24 hours

    Number of Participants with Adverse Events as a Measure of Safety and Tolerability during procedural anesthesia for intratracheal intubation in neonates

  3. Efficacy of oxycodone as an analgesic in neonates during mechanical ventilation

    Time frame: 24 hours

    Number of Participants with Adverse Events as a Measure of Safety and Tolerability in neonates after oxycodone administration during mechanical ventilation.

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Collaborators

  • University of Helsinki
  • University of Turku

Registry information

Official study title

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

Acronym: NeoPopGen

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
Apr 27, 2015
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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