This study aims to describe a dose-effect relationship of morphine alone and morphine and midazolam administered as continuous infusion in neonates hospitalized in Neonatal intensive care unit and undergoing mechanical ventilation, through PKPD modelling.
Neonates < 45 weeks of corrected gestational age
Hospitalized in a Neonatal Intensive Care Unit
Undergoing mechanical ventilation
Patients that receive morphine alone or morphine and midazolam as continuous infusion
Current weight < 600g
Neonates under palliative care
Therapeutic hypothermia for perinatal anoxia
Neonates who underwent a surgical procedure during the past 72 hours
Single group
Dose-effect relationship of morphine +/- midazolam administration
Other interventionDose-effect relationship of morphine +/- midazolam administration as continuous infusion in neonates undergoing mechanical ventilation through PKPD modelling
Effective dose for 50% of patients (ED50 ) of morphine in continuous infusion in neonates ventilated in the neonatal intensive care unit
To evaluate which dose is effective, cComfort will be assessed with COMFORTneo score (scale from 6 to 30 with decreasing score with increasing comfort). The dose-response relationship will be assessed with the correlation between a comfortable score (between 11 and 13) and the effective dose for 50% of patients (ED50), by PKPD modeling
Clearance (ml/min/kg) of morphine and midazolam
Morphine and midazolam serum levels (mg/L) will be used to describe clearance by PKPD
Volume of distribution (L/kg) of morphine and midazolam
Morphine and midazolam serum levels (mg/L) will be used to describe volume of distribution by PKPD modeling
Concentration of morphine
Morphine serum levels (mg/L) will be used to describe inter-individual variability by PKPD modeling
Concentration of midazolam
midazolam serum levels (mg/L) will be used to describe inter-individual variability by PKPD modeling
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