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Efficacy of dexmedetomidine versus midazolam sedation on extubation time in mechanically ventilated preterm infants: a randomized controlled multicenter trial (DEXPRE)
EU CTIS ID: 2023-508785-16-00
What this study is testing
To compare the efficacy of dexmedetomidine-based sedation versus midazolam-based sedation in very preterm neonates.
- 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
- Patient admitted in NICU
- Randomization criteria 2 : elective sedation (acceptable delay between the decision to sedate and the administration of the sedative agent),
- Randomization criteria 3 : presence or plan of a venous access,
- Randomization criteria 4 : no medical contraindication related to the administration of dexmedetomidine or midazolam,
- Holder(s) of parental authority must sign the written or electronic informed consent
- Holder(s) of parental authority must sign the written or electronic informed consent
You likely can't join if
- Polymalformative syndrome
- Palliative care,
- Inclusion in another clinical trial on medicinal products, clinical investigation protocol concerning a medical device or interventional protocol not concerning a health product.
- Clonidine treatment
- Parents who don't understand French
See the full eligibility criteria
- Patient admitted in NICU
- Randomization criteria 2 : elective sedation (acceptable delay between the decision to sedate and the administration of the sedative agent),
- Randomization criteria 3 : presence or plan of a venous access,
- Randomization criteria 4 : no medical contraindication related to the administration of dexmedetomidine or midazolam,
- Holder(s) of parental authority must sign the written or electronic informed consent
- Holder(s) of parental authority must sign the written or electronic informed consent
- Randomization criteria 5 : no concomitant use of curare agent
- randomization criteria 6 : no previous extubation within 7 days
- Randomization criteria 7 : no Clonidine treatment
- randomisation criteria 7 : no hemodynamic instability
- randomisation criteria 8 : no palliative care
- Gestational age at birth < 32 weeks of gestation (WG),
- Corrected gestational age <45 weeks of gestation (WG)
- Randomization criteria 1 : indication for sedation in the context of invasive mechanical ventilation
- Polymalformative syndrome
- Palliative care,
- Inclusion in another clinical trial on medicinal products, clinical investigation protocol concerning a medical device or interventional protocol not concerning a health product.
- Clonidine treatment
- Parents who don't understand French
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.