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

Turku University Hospital (TYKS)

Status and phase: Completed; Phase 4

Conditions: Critical Illness

Treatments: Drug: propofol; Drug: oxycodone

Study type: Interventional

Funder types: Other

Identifiers

NCT02426463

T65/2015

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 24 to 40 weeks old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Propofol

Active Comparator group

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.

Treatment:

Drug: propofol

Oxycodone

Active Comparator group

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.

Treatment:

Drug: oxycodone