Dexmedetomidine for Invasive Ventilation In the NEOnate
Starting soon · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Invasive Ventilation, Infant Pain, Infant Discomfort, Infant Neurodevelopment, Neonatal Respiratory Failure
In brief
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.
Key facts
- Study ID
- NCT07493785
- Run by
- Centre Hospitalier Intercommunal Creteil
- People needed
- 246
- Starts
- 2026-06-01
- Expected to finish
- 2034-08-01
- Last updated by the study team
- 2026-03-25
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Affiliated to or benefiting from a social security system
You may not qualify if…
- 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
- Hemodynamic compromise defined as any of: poor perfusion (increased capillary refill time, oliguria); hypotension defined as a mean blood pressure in mm Hg < postmenstrual age in weeks; ongoing inotropic treatment with dopamine or dobutamine ≥ 5 µg/kg/min, or any other inotropic drug at any dose, or need for more than one volume expansion (20 ml/kg) in the 6 previous hours
- Pulmonary hypertension requiring pharmacological treatment
- Heart rate <100 bpm
- Hepatic impairment defined as alanine aminotransferase level > 2 x normal upper limit
- Known contra-indications to dexmedetomidine: hypersensitivity, atrioventricular block, acute cerebrovascular event
- Hypersensitivity to the active substance or to any of the excipients contained in the medicine
Where it is running
- CHU de Nantes — Nantes, France
- CHU de Nice — Nice, France
- AP-HP Hôpital Necker Enfants Malades — Paris, France
- Hôpital NOVO - Site de Pontoise — Pontoise, France
- Centre Hospitalier de Saint -Denis — Saint-Denis, France
- CHU Félix Guyon (Saint Denis) — Saint-Denis, France
- CHU de La Réunion - Site Sud Saint-Pierre — Saint-Pierre, France
- CHU Brest - Hôpital Morvan — Brest, France
- Centre Hospitalier Intercommunal de Créteil — Créteil, France
- CHU Grenoble Alpes — Grenoble, France
- CHRU Lille — Lille, France
- CHU Limoges — Limoges, France
Full record on ClinicalTrials.gov
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