Dexmedetomidine for Invasive Ventilation In the NEOnate (NCT07493785) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
Dexmedetomidine for Invasive Ventilation In the NEOnate
France246 participantsStarted 2026-06-01
Plain-language 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.
Who can participate
Age range
10 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Above mentioned age limits (0 -10 weeks) apply to postnatal age. Inclusion criteria apply to gestational age at birth and postmenstrual age (in weeks).
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 su…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose of Opioids used
Timeframe: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last