Actively Recruiting
Efficacy of Dexmedetomidine Versus Midazolam Sedation on Extubation Time in Mechanically Ventilated Preterm Infants: a Randomized Controlled Multicenter Trial - DEXPRE
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-02-10
380
Participants Needed
1
Research Sites
93 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
D
DrData
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to compare two sedative treatments, dexmedetomidine and midazolam, for very preterm newborns born before 32 weeks who require invasive mechanical ventilation to support breathing. The study explores whether dexmedetomidine, which may have fewer side effects on breathing and brain health, can help these fragile infants be taken off the ventilator sooner compared to midazolam. The trial is designed to provide evidence on sedation quality and respiratory outcomes in neonatal intensive care units. Participants will be randomly assigned to one of two groups. One group receives dexmedetomidine through a continuous intravenous infusion, starting with a loading dose over 30 minutes followed by a maintenance dose adjusted by medical staff. The other group receives midazolam in a similar way, with a loading dose and maintenance infusion. Treatments will continue during the period of invasive mechanical ventilation until extubation. Vital signs and pain levels will be regularly monitored, and treatment doses adjusted to achieve the desired sedation level. During the study, data such as sedation quality, opioid use, timing and success of extubation, and any adverse events will be recorded. Follow-up includes a final visit when the child reaches about 2 years corrected age to assess growth, motor development, neurological status, and developmental milestones using a standardized questionnaire. The main measurement is the time from stopping sedation to extubation, with additional monitoring up to 24 months for health and survival outcomes.
CONDITIONS
Brief Title
Efficacy of Dexmedetomidine Versus Midazolam Sedation on Extubation Time in Mechanically Ventilated Preterm Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient admitted in NICU (intubated or not yet)
- Born before 32 weeks of gestation
- Corrected gestational age less than 45 weeks postmenstrual age
- Written or electronic informed consent signed by both parents
- Indication for sedation with invasive mechanical ventilation
- Elective sedation with acceptable delay before administration
- Presence or plan of venous access
- No medical contraindication to dexmedetomidine or midazolam
- No use of dexmedetomidine or midazolam within 48 hours except for intubation sedation
- No concomitant use of curare agent
- No clonidine treatment
- No previous extubation within 7 days
- No hemodynamic instability
- Not receiving palliative care
You will not qualify if you...
- Medical contraindication to dexmedetomidine or midazolam
- Previous use of dexmedetomidine or midazolam within 48 hours except for intubation sedation
- Concomitant use of curare agent
- Clonidine treatment
- Previous extubation within 7 days
- Hemodynamic instability
- Receiving palliative care
- Lack of written or electronic informed consent by both parents
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 16 days or until extubation
Participants receive continuous intravenous sedation with either dexmedetomidine or midazolam during invasive mechanical ventilation. The treatment starts with a 30-minute loading dose, followed by a maintenance dose adjusted to achieve the desired sedation level. Vital signs and pain scores are regularly recorded during treatment until extubation.
Vital signs recorded multiple times within the first 12 hours, then every 12 hours until treatment ends; pain scores recorded at 30 and 60 minutes after treatment initiation, then every 3 hours
Duration - Up to 2 years after birth (+/- 2 months)
Participants are followed until 2 years of corrected age to assess growth, neurological development, and overall health status.
1 final study visit at 2 years of corrected age
Trial Site Locations
Total: 1 location
1
Hospital Armand Trousseau, APHP Service : Department of Neonatology
Paris, France, 75012
Actively Recruiting
Research Team
C
Clément CHOLLAT, MD, PhD, Associate Professor
S
Stéphane MARRET, MD, PhD, Associate Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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