Despite the increasing use of non-invasive ventilation, a large majority of premature neonates still receive invasive ventilation during their NICU (neonatal intensive care unit) stay. Invasive ventilation is a unanimous source of discomfort and pain.
As opposed to the adult and pediatric population, routine use of opioids or midazolam is not recommended in ventilated neonates.
Although opioids are the most frequently prescribed analgosedative drugs in ventilated premature neonates, their use is controversial because of the risk of respiratory depression - which can prolong invasive ventilation- and concerns on long-term neurodevelopment.
Dexmedetomidine, a selective alpha-2- adrenergic agonist routinely used in the adult ICU (intensive care unit), provides light sedation and some analgesia with no or little respiratory-depression effect. It also has neuroprotective properties after pediatric cardiac surgery and in neonatal animal models. Dexmedetomidine is thus a promising candidate drug in ventilated premature neonates that might reduce the duration of mechanical ventilation and preserve neurodevelopment in this vulnerable population.
The investigators hypothesize that the use of dexmedetomidine in ventilated premature neonates could decrease the need for opioids, facilitate extubation and thereby preserve long-term neurodevelopmental outcome.
Neonates with a gestational age at birth < 32 weeks of gestation and corrected gestational age < 32 weeks postmenstrual age
Invasively ventilated with an expected or effective duration of ventilation > 24 hours at inclusion
Under mechanical ventilation since less than 72 hours at inclusion
With parental consent
Previous inclusion in this trial
Participation in another trial including analgesics or sedatives
Ongoing palliative care
Administration of dexmedetomidine or another alpha-2 agonist in the 96 previous hours
Parallel
Dexmedetomidine Injectable Solution
DrugIntravenous administration for maximum 20 days
Glucose 5% Injectable Solution
DrugIntravenous administration for maximum 20 days
Dose of Opioids used
Cumulative dose of opioids (morphine, sufentanil, fentanyl) converted to equivalent morphine dose in µg/kg using fixed equipotency ratios based on national prescriptions habits, administered during the studied period defined as the time between the start of the investigational drug and the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last.
Percentage of time (hours) spent within an excessive/appropriate/ insufficient comfort/analgesia state based on the COMFORTneo scale
Scores of COMFORTneo scale : * excessive: score \<11 * appropriate: score between 11 to 13 * insufficient : score \>13
Duration of invasive ventilation in hours
Number of days with opioids and/or benzodiazepines
Cumulative dose of midazolam or other benzodiazepines
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Centre Hospitalier Intercommunal Creteil
Lead sponsor
Pr Xavier DURRMEYER
Collaborator
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