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Dexmedetomidine for Invasive Ventilation In the NEOnate

StatusNot Yet Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Aug 1, 2032 → Jan 1, 2033
See other at-risk trials from Centre Hospitalier Intercommunal Creteil

Record History

  1. Notable Start date: Jun 1, 2026 to Jan 1, 2027
    • Primary completion pushed from Aug 1, 2032 to Jan 1, 2033
    • Study completion moved earlier from Aug 1, 2034 to Feb 1, 2034
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07493785
Lead Sponsor Centre Hospitalier Intercommunal Creteil
Collaborators: Pr Xavier DURRMEYER
Conditions
(from sponsor)
Invasive Ventilation, Infant Pain, Infant Discomfort, Infant Neurodevelopment, Neonatal Respiratory Failure
Related terms Agnosia, Pain, Substance Withdrawal Syndrome
Enrollment 246 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov