Dexmedetomidine for Invasive Ventilation In the NEOnate

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
AgeUp to 10
SponsorCentre Hospitalier Intercommunal Creteil

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Dexmedetomidine Injectable Solution
  • Glucose 5% Injectable Solution

Treatment groups

246 Participants
are divided into 2 treatment groups

Sponsors and collaborators