Clinical trial NCT02426463: Clinical Trial on Individual Characteristics Affecting Pain Drug Therapy in Neonates
Official title: Individualising Drug Therapy in Neonates Using Pharmacogenomic Profiling, Population Based Modeling and Simulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Critical Illness
Keywords: Neonatal intensive care
need for intratracheal intubation
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: University of Turku
name: University of Helsinki
First posted: 2015-04-27
Enrollment: 80
Sex: ALL
Minimum age (years): 24
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) of propofol and oxycodone.
timeFrame: 24 hours post-dose.
Secondary outcomes:
measure: Effect of biometric and genomic covariates on AUC
timeFrame: 24 hours post-dose
measure: Efficacy of propofol in procedural anesthesia in neonates
timeFrame: 24 hours
measure: Efficacy of oxycodone as an analgesic in neonates during mechanical ventilation
timeFrame: 24 hours
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Department of Paediatrics and Adolescent Medicine, Turku University Hospital
Study officials:
affiliation: Dept. Anaesthesiology and Intensive Care, University Of Turku
name: Teijo I Saari, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: