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Double blind, multicenter, randomized, controlled trial of dexmedetomidine vs placebo in premature neonates receiving invasive ventilation
EU CTIS ID: 2023-509247-27-00
What this study is testing
To assess the effect of continuous intravenous infusion of dexmedetomidine vs placebo on the cumulative opioids’ doses (including continuous infusion and boluses) in ventilated premature neonates with an expected or effective duration of ventilation of at least 24h.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join 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 > 24h at inclusion
- Under mechanical ventilation since less than 72h at inclusion
- With parental consents
- Affiliated to or benefiting from a social security system
You likely can't join if
- Previous inclusion in this trial
- Hypersensitivity to the active substance or to any of the excipients contained in the medicine
- 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
See the full eligibility 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 > 24h at inclusion
- Under mechanical ventilation since less than 72h at inclusion
- With parental consents
- Affiliated to or benefiting from a social security system
- Previous inclusion in this trial
- Hypersensitivity to the active substance or to any of the excipients contained in the medicine
- 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 > 2x normal upper limit
- Known contra-indications to dexmedetomidine: hypersensitivity, atrioventricular block, acute cerebrovascular event
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.