Clinical trial on individual characteristics affecting pain drug therapy in neonates.

Individualising propofol and oxycodone therapy in neonates using pharmacogenomic profiling, population based modeling and simulations.

Status

Active, not recruiting

Phases

Phase 1Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005577-36-FI

Enrollment

Registered

2015-03-25

Start date

2015-04-02

Completion date

Unknown

Last updated

2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonates, who need to be intubated and ventilated with a ventilator.

Interventions

Trade Name: Propofol-Lipuro 10 mg/ml Pharmaceutical Form: Infusion INN or Proposed INN: PROPOFOL Other descriptive name: PROPOFOL Trade Name: OXANEST® 10 mg/ml Pharmaceutical Form: Infusion INN or P

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: A neonate, who needs to be intubated and artificially ventilated. Are the trial subjects under 18? yes Number of subjects for this age range: 80 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Refusal to participate. 2. Failure to get informed concent.

Design outcomes

Primary

Measure	Time frame
Main Objective: In this project, the mechanisms defining the dose response in pediatric population will be explored.Propofol and oxycodone will be studied to describe the development and maturation of pharmacokinetics and –dynamics in neonates. Population models are constructed to describe the dose-response relationship.;Secondary Objective: Pharmacogenomic effects will be mapped with exome sequencing to account for their effects in the drug response in this population.;Primary end point(s): 24 hour time after intubation;Timepoint(s) of evaluation of this end point: 3 to 10 paired blood samples to be drawn with Phenomenex Mitra microsampling device. Blood samples are drawn coinciding normal clinical blood sampling, no additional samples are drawn. Maximum blood volume to be drawn is 60 to 200 µl depending on the weight of the neonate (total volume must not exceed 3% of the estimated blood volume of 90 ml/kg)	—

Measure

Time frame

Main Objective: In this project, the mechanisms defining the dose response in pediatric population will be explored.Propofol and oxycodone will be studied to describe the development and maturation of pharmacokinetics and –dynamics in neonates. Population models are constructed to describe the dose-response relationship.;Secondary Objective: Pharmacogenomic effects will be mapped with exome sequencing to account for their effects in the drug response in this population.;Primary end point(s): 24 hour time after intubation;Timepoint(s) of evaluation of this end point: 3 to 10 paired blood samples to be drawn with Phenomenex Mitra microsampling device. Blood samples are drawn coinciding normal clinical blood sampling, no additional samples are drawn. Maximum blood volume to be drawn is 60 to 200 µl depending on the weight of the neonate (total volume must not exceed 3% of the estimated blood volume of 90 ml/kg)

—

Secondary

Measure	Time frame
Secondary end point(s): When applicable (see 5.1.1), a single blood sample of 100 µl is drawn during the study for genomic analysis (Next generation exome sequencing).;Timepoint(s) of evaluation of this end point: Whenever during the study coinciding clinical blood sampling.	—

Countries

Finland

Contacts

Public ContactTurkuCRC

Turku Clinical Research Centre

teijo.saari@gmail.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026