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Problems with the study costs after Covid-19
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| Name | Class |
|---|---|
| Lund University | OTHER |
| Karolinska Institutet | OTHER |
| Helsinki University Central Hospital | OTHER |
| Great Ormond Street Hospital for Children NHS Foundation Trust |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dexmedetomidine | Infusion of dexmedetomidine 4 microgram/mL. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexmedetomidine | Drug | The dosing and administration will be implemented according to an algorithm based on pain scoring results |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline until 12 hours after stop of infusion |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Sick newborn infants in need of intensive care.
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| Name | Affiliation | Role |
|---|---|---|
| Elisabeth Norman, MD | Region Skane | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skane University Hospital | Lund | 221 85 | Sweden | |||
| Karolinska Universitetssjukhuset |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| OTHER |
| Örebro University, Sweden | OTHER |
| The Swedish Research Council | OTHER_GOV |
| University of Tartu | OTHER |
| University of Colorado, Denver | OTHER |
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Whole blood
| 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. | 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 | 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; | Once during treatment with dexmedetomidine |
| Stockholm |
| 171 76 |
| Sweden |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |