Critical IllnessPhase 4NeoPopGenNCT02426463
Clinical Trial on Individual Characteristics Affecting Pain Drug Therapy in Neonates
A Phase 4 study testing propofol and oxycodone in people with Critical Illness, run by Turku University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 40 weeks
- Conditions the study is for
- Critical Illness
- What is being tested?
- propofol and oxycodone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFinland
- Study dates
- 20 Apr 2015to 31 Jan 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 40 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Finland1 site
Department of Paediatrics and Adolescent Medicine, Turku University Hospital
Turku, 20521
About this study
Official title: Individualising Drug Therapy in Neonates Using Pharmacogenomic Profiling, Population Based Modeling and Simulations
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.
- Conditions
- Critical Illness
- Keywords
- Neonatal intensive care, need for intratracheal intubation
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Active comparator | 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. Receives: Drug: propofol |
| Oxycodone | Active comparator | 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. Receives: Drug: oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours post-dose.
Secondary outcomes (3)
Effect of biometric and genomic covariates on AUC
Covariate analysis and simulations to individualize population models
Measured: 24 hours post-dose
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
Measured: 24 hours
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study start20 Apr 2015
- Primary completion28 Feb 2017
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- University of Turku, University of Helsinki
- Responsible party
- Sponsor
- Investigators
- Teijo I Saari, MD, PhD, Principal investigator, Dept. Anaesthesiology and Intensive Care, University Of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426463
- Sponsor's protocol ID
- T65/2015
- Acronym
- NeoPopGen
- Status last verified
- Feb 2019
- First submitted
- 13 Apr 2015
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualising Drug Therapy in Neonates Using Pharmacogenomic Profiling, Population Based Modeling and Simulations
- ClinicalTrials.gov ID
- NCT02426463
- Acronym / sponsor ID
- NeoPopGen / T65/2015
- Conditions
- Critical Illness
- Keywords
- Neonatal intensive care, need for intratracheal intubation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- University of Turku, University of Helsinki
- Study start
- 20 Apr 2015 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 27 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Drug: propofolPlasma 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. |
| Oxycodone | Active comparator | Drug: oxycodonePlasma 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. |
Who may qualify
- Ages
- 24 to 40 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propofol | Drug | Propofol |
| oxycodone | Drug | Oxycodone |
Primary outcome
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.
3 secondary outcomes
Effect of biometric and genomic covariates on AUC
Time frame: 24 hours post-dose
Efficacy of propofol in procedural anesthesia in neonates
Time frame: 24 hours
Efficacy of oxycodone as an analgesic in neonates during mechanical ventilation
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teijo I Saari, MD, PhD principal investigator
Dept. Anaesthesiology and Intensive Care, University Of Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing propofol and oxycodone in people with Critical Illness, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration versus time curve (AUC) of propofol and oxycodone. (time frame: 24 hours post-dose.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.