Intensive Care, NeonatalNCT06482775
Dexmedetomidine for Analgosedation to Newborn Infants During Neonatal Intensive Care
An observational study of Intensive Care, Neonatal and Analgesia, run by Region Skane at 2 sites in Sweden.
Trial summary
A prospective pharmacokinetic (PK), pharmacodynamic (PD) and pharmacogenetic (PG) observation study, including the PK/PD/PG relationship, on dexmedetomidine administered for analgesia and sedation to postsurgical and other newborn sick infants needing the drug for clinical reasons during neonatal intensive care. Read more about this study
- Who is it for?
- Ages Up to 27 days
- Conditions the study is for
- Intensive Care, Neonatal, Analgesia, Hypnotics and Sedatives
- What is being tested?
- dexmedetomidine
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Jun 2021to 31 Dec 2021
- Phase
- Observational
- 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 Up to 27 days
- All sexes
- No healthy volunteers
- Child
Study population: Sick newborn infants in need of intensive care.
Who may be able to join
- Newborn infants: - born 34+0 gw with a need for dexmedetomidine for analgesic and/or sedative treatment after postnatal surgical correction of congenital malformations and who will be cared for in the PICU (postoperative intensive care unit) and in a some few cases in the NICU (neonatal intensive care unit), or
- with a corresponding age of 37 gw, who are in need for dexmedetomidine according to clinical judgment and cared for in the NICU.
- Existing arterial or venous cannulas/catheters for repeated nontraumatic blood sampling
- Informed and written parental consent obtained before study start.
Who cannot join
- Infant older than age corresponding to gw 46+0
- Previous treatment with the dexmedetomidine within 72 hours (only for postoperative infants).
- Congenital cardiac malformations requiring surgery on extracorporeal circulation and treatment with hypothermia.
- Ongoing renal replacement treatment
- Any serious medical condition or ethical issues that could, in the investigators opinion, interfere with the study procedures.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Skane University Hospital
Lund, 221 85
Karolinska Universitetssjukhuset
Stockholm, 171 76
About this study
Official title: Dexmedetomidine for Analgosedation to Newborn Infants During Neonatal Intensive Care - a Prospective Pharmacokinetic/ Pharmacodynamic/ Pharmacogenetic Observational Study.Cohort 3 in The SANNI Project.
A prospective pharmacokinetic (PK), pharmacodynamic (PD) and pharmacogenetic (PG) observation study, including the PK/PD/PG relationship, on dexmedetomidine administered for analgesia and sedation to postsurgical and other newborn sick infants needing the drug for clinical reasons during neonatal intensive care. Phase III - therapeutic confirmatory study.
Read the detailed description
The patients will be treated according to clinical guidelines and judgement as decided by the responsible clinical doctor.
The dosing and administration of dexmedetomidine will be implemented according to an algorithm based on pain scoring results.
Apart from extra blood sampling and extended bedside monitoring for amplitude-integrated EEG (aEEG), Near InfraRed Spectroscopy (NIRS), and Galvanic Skin Response (GSR) the care is according to clinical routine.
In total 100 infants will be included.
- Conditions
- Intensive Care, Neonatal, Analgesia, Hypnotics and Sedatives
- Being tested
- dexmedetomidine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidineDrug
The dosing and administration will be implemented according to an algorithm based on pain scoring results
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine | Infusion of dexmedetomidine 4 microgram/mL. Receives: Drug: dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) of dexmedetomidine
The plasma concentration will be analysed and then further reported using NONMEM® (Non-linear Mixed Effect Modelling) population-based PK modelling.
Measured: Repeated blood samples (5 minutes after the loading dose until 12 hours after stop of infusion)
Neurophysiologic response; global brain network function in relation to PK
Assessment of global brain network function will be based on Activation Synchrony Index.
Measured: Baseline until 12 hours after stop of infusion
Secondary outcomes (4)
Change in heart rate, HR, (hemodynamic response) in relation to PK (PK/PD)
HR will be monitored 1/second according to clinical routine in the neonatal intensive care, and concomitantly downloaded into the aEEG (amplitude integrated electroencephalography) monitor. The change will be described as percentage increase/decrease. The change from baseline response in heart rate using longitudinal models of data on these endpoints following dexmedetomidine administration using a population PK/PD approach.
Measured: Baseline until 12 hours after stop of infusion
Change in mean arterial blood pressure, MABP, (hemodynamic response) in relation to PK (PK/PD)
MABP will be monitored 1/second according to clinical routine in the neonatal intensive care, and concomitantly downloaded into the aEEG (amplitude integrated electroencephalography) monitor. The change will be described as percentage increase/decrease. The change from baseline response in MABP using longitudinal models of data on these endpoints following dexmedetomidine administration using a population PK/PD approach.
Measured: Baseline until 12 hours after stop of infusion
Change in/association between Near Infrared spectroscopy, NIRS, in relation to PK.
NIRS will be monitored 1/second according to clinical routine in the neonatal intensive care, and concomitantly downloaded into the aEEG (amplitude integrated electroencephalography) monitor. The change will be described as percentage increase/decrease
Measured: Once per second (from baseline until 12 hours after stop of infusion)
Procedural pain response in relation to PK: assessed with change in galvanic skin response
Procedural pain response at a short standardized pain stimulation;
Measured: Once during treatment with dexmedetomidine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start1 Jun 2021
- Primary completion1 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Why it stopped: Problems with the study costs after Covid-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care, NeonatalStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University, Karolinska Institutet, Helsinki University Central Hospital, Great Ormond Street Hospital for Children NHS Foundation Trust, Örebro University, Sweden, The Swedish Research Council, University of Tartu, University of Colorado, Denver
- Responsible party
- Sponsor
- Investigators
- Elisabeth Norman, MD, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482775
- Sponsor's protocol ID
- 2015-002506-37
- Other IDs
- 2015
- Status last verified
- Jun 2021
- First submitted
- 4 Aug 2020
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine for Analgosedation to Newborn Infants During Neonatal Intensive Care - a Prospective Pharmacokinetic/ Pharmacodynamic/ Pharmacogenetic Observational Study.Cohort 3 in The SANNI Project.
- ClinicalTrials.gov ID
- NCT06482775
- Acronym / sponsor ID
- 2015-002506-37
- Conditions
- Intensive Care, Neonatal, Analgesia, Hypnotics and Sedatives
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Problems with the study costs after Covid-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University, Karolinska Institutet, Helsinki University Central Hospital, Great Ormond Street Hospital for Children NHS Foundation Trust, Örebro University, Sweden, The Swedish Research Council, University of Tartu, University of Colorado, Denver
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 1 Jul 2024 (actual)
- 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.
A prospective pharmacokinetic (PK), pharmacodynamic (PD) and pharmacogenetic (PG) observation study, including the PK/PD/PG relationship, on dexmedetomidine administered for analgesia and sedation to postsurgical and other newborn sick infants needing the drug for clinical reasons during neonatal intensive care. Phase III - therapeutic confirmatory study.
Detailed description
The patients will be treated according to clinical guidelines and judgement as decided by the responsible clinical doctor.
The dosing and administration of dexmedetomidine will be implemented according to an algorithm based on pain scoring results.
Apart from extra blood sampling and extended bedside monitoring for amplitude-integrated EEG (aEEG), Near InfraRed Spectroscopy (NIRS), and Galvanic Skin Response (GSR) the care is according to clinical routine.
In total 100 infants will be included.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine | – | Drug: dexmedetomidineInfusion of dexmedetomidine 4 microgram/mL. |
Who may qualify
- Ages
- Up to 27 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Sick newborn infants in need of intensive care.
Key inclusion criteria (4 listed)
- Newborn infants: - born 34+0 gw with a need for dexmedetomidine for analgesic and/or sedative treatment after postnatal surgical correction of congenital malformations and who will be cared for in the PICU (postoperative intensive care unit) and in a some few cases in the NICU (neonatal intensive care unit), or
- with a corresponding age of 37 gw, who are in need for dexmedetomidine according to clinical judgment and cared for in the NICU.
- Existing arterial or venous cannulas/catheters for repeated nontraumatic blood sampling
- Informed and written parental consent obtained before study start.
Key exclusion criteria (5 listed)
- Infant older than age corresponding to gw 46+0
- Previous treatment with the dexmedetomidine within 72 hours (only for postoperative infants).
- Congenital cardiac malformations requiring surgery on extracorporeal circulation and treatment with hypothermia.
- Ongoing renal replacement treatment
- Any serious medical condition or ethical issues that could, in the investigators opinion, interfere with the study procedures.
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 |
|---|---|---|
| dexmedetomidineThe dosing and administration will be implemented according to an algorithm based on pain scoring results | Drug | dexmedetomidine |
Primary outcome
Pharmacokinetics (PK) of dexmedetomidine
Time frame: Repeated blood samples (5 minutes after the loading dose until 12 hours after stop of infusion)
The plasma concentration will be analysed and then further reported using NONMEM® (Non-linear Mixed Effect Modelling) population-based PK modelling.
Neurophysiologic response; global brain network function in relation to PK
Time frame: Baseline until 12 hours after stop of infusion
Assessment of global brain network function will be based on Activation Synchrony Index.
4 secondary outcomes
Change in heart rate, HR, (hemodynamic response) in relation to PK (PK/PD)
Time frame: Baseline until 12 hours after stop of infusion
Change in mean arterial blood pressure, MABP, (hemodynamic response) in relation to PK (PK/PD)
Time frame: Baseline until 12 hours after stop of infusion
Change in/association between Near Infrared spectroscopy, NIRS, in relation to PK.
Time frame: Once per second (from baseline until 12 hours after stop of infusion)
Procedural pain response in relation to PK: assessed with change in galvanic skin response
Time frame: Once during treatment with dexmedetomidine
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Elisabeth Norman, MD principal investigator
Region Skane
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care, Neonatal and Analgesia, run by Region Skane at 2 sites in Sweden.
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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Pharmacokinetics (PK) of dexmedetomidine (time frame: Repeated blood samples (5 minutes after the loading dose until 12 hours after stop of infusion)). The study lists 2 primary outcomes in all. 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 1 Jul 2024.