NCT07493785

Dexmedetomidine for Invasive Ventilation In the NEOnate

Double Blind, Multicenter, Randomized, Controlled Trial of Dexmedetomidine vs Placebo in Premature Neonates Receiving Invasive Ventilation

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 246 (estimated)
• Sponsor: Centre Hospitalier Intercommunal Creteil · Academic / Other
• Sex: All
• Age: 10 Weeks
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Invasive Ventilation
• Infant Pain
• Infant Discomfort
• Infant Neurodevelopment
• Neonatal Respiratory Failure

Interventions

Type	Name	Description
DRUG	Dexmedetomidine Injectable Solution	Intravenous administration for maximum 20 days
DRUG	Glucose 5% Injectable Solution	Intravenous administration for maximum 20 days

Timeline

• Start date: 2026-06-01
• Primary completion: 2032-08-01
• Completion: 2034-08-01
• First posted: 2026-03-25
• Last updated: 2026-03-25

Locations

12 sites across 1 country: France