Dexmedetomidine for Analgosedation to Newborn Infants During Neonatal Intensive Care
NCT Number: NCT06482775
Status: WITHDRAWN
Study Type: OBSERVATIONAL
Conditions: Intensive Care, Neonatal|Analgesia|Hypnotics and Sedatives
Interventions: DRUG: dexmedetomidine
Sponsor: Region Skane
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
Sex: ALL
Age: CHILD
Enrollment: 0
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-06-01
Completion Date: 2021-12-31
Locations: Skane University Hospital, Lund, 221 85, Sweden|Karolinska Universitetssjukhuset, Stockholm, 171 76, Sweden

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. Phase III - therapeutic confirmatory study.

Primary Outcome Measures: 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
Secondary Outcome Measures: 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., 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