Stopped: Problems with the study costs after Covid-19
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.
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Pharmacokinetics (PK) of dexmedetomidine
Timeframe: 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
Timeframe: Baseline until 12 hours after stop of infusion