PreTerm NeonatePhase 3DEXPRENCT06878703
Efficacy of Dexmedetomidine Versus Midazolam Sedation on Extubation Time in Mechanically Ventilated Preterm Infants
A Phase 3 study testing Midazolam and Dexmedetomidine in people with PreTerm Neonate and Sedation for Invasive Mechanical Ventilation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Very preterm neonates (born before 32 weeks' gestation) often require invasive mechanical ventilation (IMV) to manage respiratory insufficiency. In France, around 8,250 infants are born annually at <32 weeks, with an estimated 5,000 needing IMV. Read more about this study
- Who is it for?
- Ages Up to 32 weeks
- Conditions the study is for
- PreTerm Neonate, Sedation for Invasive Mechanical Ventilation, Very Preterm Neonates With Sedation for Invasive Mechanical Ventilation
- What is being tested?
- Midazolam and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2025to 16 Oct 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient admitted in NICU (intubated or not yet),
- Gestational age at birth < 32 weeks of gestation (WG),
- Corrected gestational age <45 weeks postmenstrual age Written or electronic informed consent signed by both parents.
- Randomization Criteria :
- Indication for sedation in the context of invasive mechanical ventilation,
- Patient intubated or not yet,
Show all 15Show fewer
- Elective sedation (acceptable delay between the decision to sedate and the administration of the sedative agent),
- Presence or plan of a venous access,
- No medical contraindication related to the administration of dexmedetomidine or midazolam,
- No previous use of dexmedetomidine or midazolam within 48 hours, except for the sedation procedure for intubation,
- No concomitant use of curare agent,
- No clonidine treatment,
- No previous extubation within 7 days,
- No hemodynamic instability
- No palliative care,
Who cannot join
- Patient admitted in NICU (intubated or not yet),
- Gestational age at birth < 32 weeks of gestation (WG),
- Corrected gestational age <45 weeks postmenstrual age Written or electronic informed consent signed by both parents.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hospital Armand Trousseau, APHP Service : Department of Neonatology
Paris, 75012
Clément CHOLLAT, Doctor, +33 6 86 72 29 58, clement.chollat@aphp.fr
About this study
Official title: Efficacy of Dexmedetomidine Versus Midazolam Sedation on Extubation Time in Mechanically Ventilated Preterm Infants: a Randomized Controlled Multicenter Trial - DEXPRE
Very preterm neonates (born before 32 weeks' gestation) often require invasive mechanical ventilation (IMV) to manage respiratory insufficiency. In France, around 8,250 infants are born annually at <32 weeks, with an estimated 5,000 needing IMV. Although non-invasive support such as continuous positive airway pressure (CPAP) has become more common, a substantial proportion of these neonates still transition to IMV within the first few days of life. To reduce lung injury and the incidence of bronchopulmonary dysplasia (BPD), a key strategy in neonatal intensive care involves limiting the duration of IMV and promoting earlier extubation.
However, effective sedation and analgesia are essential for preterm infants subjected to intubation and mechanical ventilation. Traditionally, neonatologists combine a sedative (frequently midazolam) with an opioid (morphine, fentanyl, or sufentanil). Although these agents control pain and distress, they may cause respiratory depression, complicate weaning, and potentially contribute to adverse long-term outcomes. Midazolam, one of the few sedatives authorized for use in neonates, can improve comfort and sedation scores, but concerns persist about hypotension, altered cerebral perfusion, and a possible link to intraventricular hemorrhage (IVH). Moreover, combining benzodiazepines and opioids can prolong ventilation, increase the risk of complications, and impede timely extubation.
Read more
Rationale for Dexmedetomidine (DEX) Dexmedetomidine (DEX) is a highly selective α2-adrenergic agonist that offers sedative, anxiolytic, and analgesic properties with relatively minimal respiratory depression. Unlike certain other sedatives, DEX induces a state akin to natural sleep, allowing for easier arousal and potentially better respiratory drive. Animal studies suggest that DEX might be neuroprotective, reducing inflammation, oxidative stress, and apoptotic processes that can be detrimental to the developing brain. These features make DEX a promising alternative to the commonly used benzodiazepine-opioid regimens in very preterm neonates, who remain especially vulnerable to adverse drug effects.
Minimizing Invasive Mechanical Ventilation Reducing the time on IMV is crucial for preventing ventilator-induced lung injury and decreasing the likelihood of BPD. Early extubation is a central goal in this population, but sedation-related respiratory depression can thwart successful weaning and lead to reintubation. By preserving spontaneous breathing more effectively than midazolam or high-dose opioids, DEX may help neonates maintain adequate ventilation as they transition to non-invasive support. Furthermore, DEX's analgesic action could reduce the need for opioids, thereby mitigating withdrawal risks and other opioid-related complications such as feeding intolerance and extended hospital stays.
Objective of the DEXPRE Trial The objective of the DEXPRE trial is to compare the efficacy of dexmedetomidine-based sedation with that of midazolam-based sedation in very preterm neonates requiring IMV. Specifically, investigators aim to determine whether DEX can facilitate more rapid extubation and better overall respiratory outcomes compared to midazolam. By systematically evaluating sedation quality, respiratory stability, and potential side effects, the trial seeks to generate evidence that will guide future sedation protocols in neonatal intensive care units.
Read the detailed description
Hypothesis : the use of dexmedetomidine (DEX), 0.05 to 0.2 μg/kg/h, for very preterm neonates (<32 weeks' gestation, WG), requiring prolonged sedation throughout the period of invasive mechanical ventilation (IMV) (usually after intubation and until extubation), may improve weaning, and thus reduce extubation time in neonatal intensive care units.
Population of study participants : Very preterm neonate (gestational age at birth < 32 WG) with corrected gestational age <45 WG).
In the experimental group, neonates will receive dexmedetomidine via continuous intravenous infusion, starting with a 0.05 μg/kg loading dose over 30 minutes, followed by a maintenance dose ranging from 0.05 to 0.2 μg/kg per hour.
In the control group, neonates will receive midazolam via continuous intravenous infusion, starting with a 10 μg/kg loading dose over 30 minutes, followed by a maintenance dose ranging from 10 to 40 μg/kg per hour.
To achieve the randomization of 292 patients, an estimated enrollment of about 380 participants is anticipated, resulting in an allocation of 146 patients per study arm.
During the inclusion visit, after verifying the inclusion and exclusion criteria, an investigator will inform the parents of eligible neonates. If the neonate requires invasive mechanical ventilation and meets the randomization criteria, the investigator will proceed with the randomization.
According to the allocation arm, the nurse in charge of the patient will be able to prepare the experimental treatment using the kit provided by the hospital pharmacy.
The experimental treatment will start with a 30-minute loading dose, followed by a maintenance dose. The infusion rate will be adjusted according to medical prescriptions to achieve the desired sedation level, ranging from 0.1 mL/hr to 0.4 mL/hr. This treatment can be administered via any venous line, either peripheral or central.
Vital signs will be regularly recorded at 5, 10, 30, and 60 minutes, then at 2, 3, 6, and 12 hours after the start of treatment. Following this, recordings will be taken every 12 hours until the treatment ends.
Pain scores will be recorded 30 and 60 minutes after the initiation of treatment, and then every 3 hours, following standard practice.
On the day of extubation, routine data recording will include the timing and duration of experimental treatment and opioid interruptions, the extubation time, vital signs before and after treatment discontinuation, and any adverse events.
The final study visit will occur when the child reaches 2 years of corrected age +/- 2 months. At this visit, weight, height, head circumference, cerebral palsy status, age of walking acquisition, and the Ages \& Stages Questionnaire (ASQ) score will be recorded.
- Conditions
- PreTerm Neonate, Sedation for Invasive Mechanical Ventilation, Very Preterm Neonates With Sedation for Invasive Mechanical Ventilation
- Being tested
- Midazolam, Dexmedetomidine
- Keywords
- Mechanical ventilation, Sedative agent, Sedation-analgesia, Midazolam, Extubation, Very preterm neonate, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Continuous intravenous administration with a loading dose of 10 µg/kg over 30 min, followed by a maintenance dose (from 10 to 40 µg/kg/h)
DexmedetomidineDrug
Continuous intravenous administration with a loading dose of 0.05 μg/kg over 30 minutes followed by a maintenance dose (from 0.05 to 0.2 μg/kg/h)
| Study group | Role | What they receive |
|---|---|---|
| Midazolam | Active comparator | In the control group, neonates will receive midazolam intravenously, starting with a 10 μg/kg loading dose over 30 minutes, followed by a maintenance dose of 10-40 μg/kg/h. Receives: Drug: Midazolam |
| Dexmedetomidine | Experimental | In the experimental group, neonates will receive continuous intravenous administration of dexmedetomidine, with a loading dose of 0.05 μg/kg over 30 minutes followed by a continuous maintenance dose (from 0.05 to 0.2 μg/kg/hour). Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time, measured in minutes, is evaluated from the discontinuation of the experimental treatment (either dexmedetomidine-based or midazolam-based sedation) to extubation.
to compare the efficacy of dexmedetomidine-based sedation versus midazolam-based sedation in very preterm neonates.
Measured: from the discontinuation of the experimental treatment to extubation (48 maximum)
Secondary outcomes (6)
Administration of Opioid Agents During Sedation with Dexmedetomidine or Midazolam in Neonatal Intensive Care.
Administration of opioid agents during the period of interest, i.e., from the start of treatment (DEX or midazolam) until extubation (total cumulative dose and morphine equivalents in mg/kg, duration). opioids include morphine (1), fentanyl (0.010), remifentanil (0.15), sufentanil (0.003) and methadone (0.3).
Measured: from the start of treatment (dexmedetomidine or midazolam) until extubation (16 days maximum)
Quality of sedation
Time (in hours) between start of sedation and achievement of a normal Comfort B score (ie. between 11 and 17),
Measured: Before sedation, then every 30 min after sedation initiation, then every 3 hours after the initial 60 min, and up to 14 days
Extubation failure 24 hours after extubation
Intubation proportion at 24 hours after extubation.
Measured: In 24 hours after extubation
Withdrawal syndrome (Finnegan score >8).
Proportion of patients with at least one value of the Finnegan score > 8 from within 3 days after extubation.
Measured: 6 hours, within 7 days after extubation.
Hemodynamic and respiratory adverse effects between inclusion and 84 hours after treatment discontinuation,
- Bradycardia defined by heart rate < 80 bpm considered as clinically significant by the treating physician, despite optimization of hemodynamic management
- Hemodynamic instability defined by a mean blood pressure below corrected GA, or a skin recoloration time > 3 seconds despite optimization of haemodynamic management
- Desaturation <85% despite optimization of mechanical ventilation
- Reintubation
Measured: From start of the sedation until 84 h after the sedative is stopped (maximum 18 days)
In hospital morbi mortality.
Severe neonatal morbidity as :
- late onset sepsis defined by a positive blood culture and antibiotic therapy more than 72 hours,
- necrotizing enterocolitis according to Bell's definition61
- moderate (fraction of inspired oxygen (FiO2) <30%) and severe (FiO2 ≥30%) bronchopulmonary dysplasia at 36 WG defined by need of IMV, nasal continuous positive airway pressure, or nasal cannula at 36 weeks postmenstrual age, according to Jobe's definition
- retinopathy of prematurity is diagnosed at the fundus performed systematically before discharge, intraventricular hemorrhage diagnosed on routine transfontanelar ultrasound, according to Papile classification
Measured: the period of hospitalization and within the limit of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start16 Oct 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion16 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreTerm NeonateStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- DrData
- Responsible party
- Sponsor
- Investigators
- Clément CHOLLAT, Doctor, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878703
- Sponsor's protocol ID
- APHP230813
- Acronym
- DEXPRE
- Status last verified
- Feb 2026
- First submitted
- 21 Feb 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dexmedetomidine Versus Midazolam Sedation on Extubation Time in Mechanically Ventilated Preterm Infants: a Randomized Controlled Multicenter Trial - DEXPRE
- ClinicalTrials.gov ID
- NCT06878703
- Acronym / sponsor ID
- DEXPRE / APHP230813
- Conditions
- PreTerm Neonate, Sedation for Invasive Mechanical Ventilation, Very Preterm Neonates With Sedation for Invasive Mechanical Ventilation
- Keywords
- Mechanical ventilation, Sedative agent, Sedation-analgesia, Midazolam, Extubation, Very preterm neonate, Dexmedetomidine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- DrData
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 16 Oct 2029 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Very preterm neonates (born before 32 weeks' gestation) often require invasive mechanical ventilation (IMV) to manage respiratory insufficiency. In France, around 8,250 infants are born annually at <32 weeks, with an estimated 5,000 needing IMV. Although non-invasive support such as continuous positive airway pressure (CPAP) has become more common, a substantial proportion of these neonates still transition to IMV within the first few days of life. To reduce lung injury and the incidence of bronchopulmonary dysplasia (BPD), a key strategy in neonatal intensive care involves limiting the duration of IMV and promoting earlier extubation.
However, effective sedation and analgesia are essential for preterm infants subjected to intubation and mechanical ventilation. Traditionally, neonatologists combine a sedative (frequently midazolam) with an opioid (morphine, fentanyl, or sufentanil). Although these agents control pain and distress, they may cause respiratory depression, complicate weaning, and potentially contribute to adverse long-term outcomes. Midazolam, one of the few sedatives authorized for use in neonates, can improve comfort and sedation scores, but concerns persist about hypotension, altered cerebral perfusion, and a possible link to intraventricular hemorrhage (IVH). Moreover, combining benzodiazepines and opioids can prolong ventilation, increase the risk of complications, and impede timely extubation.
Rationale for Dexmedetomidine (DEX) Dexmedetomidine (DEX) is a highly selective α2-adrenergic agonist that offers sedative, anxiolytic, and analgesic properties with relatively minimal respiratory depression. Unlike certain other sedatives, DEX induces a state akin to natural sleep, allowing for easier arousal and potentially better respiratory drive. Animal studies suggest that DEX might be neuroprotective, reducing inflammation, oxidative stress, and apoptotic processes that can be detrimental to the developing brain. These features make DEX a promising alternative to the commonly used benzodiazepine-opioid regimens in very preterm neonates, who remain especially vulnerable to adverse drug effects.
Minimizing Invasive Mechanical Ventilation Reducing the time on IMV is crucial for preventing ventilator-induced lung injury and decreasing the likelihood of BPD. Early extubation is a central goal in this population, but sedation-related respiratory depression can thwart successful weaning and lead to reintubation. By preserving spontaneous breathing more effectively than midazolam or high-dose opioids, DEX may help neonates maintain adequate ventilation as they transition to non-invasive support. Furthermore, DEX's analgesic action could reduce the need for opioids, thereby mitigating withdrawal risks and other opioid-related complications such as feeding intolerance and extended hospital stays.
Objective of the DEXPRE Trial The objective of the DEXPRE trial is to compare the efficacy of dexmedetomidine-based sedation with that of midazolam-based sedation in very preterm neonates requiring IMV. Specifically, investigators aim to determine whether DEX can facilitate more rapid extubation and better overall respiratory outcomes compared to midazolam. By systematically evaluating sedation quality, respiratory stability, and potential side effects, the trial seeks to generate evidence that will guide future sedation protocols in neonatal intensive care units.
Detailed description
Hypothesis : the use of dexmedetomidine (DEX), 0.05 to 0.2 μg/kg/h, for very preterm neonates (<32 weeks' gestation, WG), requiring prolonged sedation throughout the period of invasive mechanical ventilation (IMV) (usually after intubation and until extubation), may improve weaning, and thus reduce extubation time in neonatal intensive care units.
Population of study participants : Very preterm neonate (gestational age at birth < 32 WG) with corrected gestational age <45 WG).
In the experimental group, neonates will receive dexmedetomidine via continuous intravenous infusion, starting with a 0.05 μg/kg loading dose over 30 minutes, followed by a maintenance dose ranging from 0.05 to 0.2 μg/kg per hour.
In the control group, neonates will receive midazolam via continuous intravenous infusion, starting with a 10 μg/kg loading dose over 30 minutes, followed by a maintenance dose ranging from 10 to 40 μg/kg per hour.
To achieve the randomization of 292 patients, an estimated enrollment of about 380 participants is anticipated, resulting in an allocation of 146 patients per study arm.
During the inclusion visit, after verifying the inclusion and exclusion criteria, an investigator will inform the parents of eligible neonates. If the neonate requires invasive mechanical ventilation and meets the randomization criteria, the investigator will proceed with the randomization.
According to the allocation arm, the nurse in charge of the patient will be able to prepare the experimental treatment using the kit provided by the hospital pharmacy.
The experimental treatment will start with a 30-minute loading dose, followed by a maintenance dose. The infusion rate will be adjusted according to medical prescriptions to achieve the desired sedation level, ranging from 0.1 mL/hr to 0.4 mL/hr. This treatment can be administered via any venous line, either peripheral or central.
Vital signs will be regularly recorded at 5, 10, 30, and 60 minutes, then at 2, 3, 6, and 12 hours after the start of treatment. Following this, recordings will be taken every 12 hours until the treatment ends.
Pain scores will be recorded 30 and 60 minutes after the initiation of treatment, and then every 3 hours, following standard practice.
On the day of extubation, routine data recording will include the timing and duration of experimental treatment and opioid interruptions, the extubation time, vital signs before and after treatment discontinuation, and any adverse events.
The final study visit will occur when the child reaches 2 years of corrected age +/- 2 months. At this visit, weight, height, head circumference, cerebral palsy status, age of walking acquisition, and the Ages \& Stages Questionnaire (ASQ) score will be recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midazolam | Active comparator | Drug: MidazolamIn the control group, neonates will receive midazolam intravenously, starting with a 10 μg/kg loading dose over 30 minutes, followed by a maintenance dose of 10-40 μg/kg/h. |
| Dexmedetomidine | Experimental | Drug: DexmedetomidineIn the experimental group, neonates will receive continuous intravenous administration of dexmedetomidine, with a loading dose of 0.05 μg/kg over 30 minutes followed by a continuous maintenance dose (from 0.05 to 0.2 μg/kg/hour). |
Who may qualify
- Ages
- Up to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- Patient admitted in NICU (intubated or not yet),
- Gestational age at birth < 32 weeks of gestation (WG),
- Corrected gestational age <45 weeks postmenstrual age Written or electronic informed consent signed by both parents.
- Indication for sedation in the context of invasive mechanical ventilation,
- Patient intubated or not yet,
Key exclusion criteria (3 listed)
- Patient admitted in NICU (intubated or not yet),
- Gestational age at birth < 32 weeks of gestation (WG),
- Corrected gestational age <45 weeks postmenstrual age Written or electronic informed consent signed by both parents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidazolamContinuous intravenous administration with a loading dose of 10 µg/kg over 30 min, followed by a maintenance dose (from 10 to 40 µg/kg/h) | Drug | Midazolam |
| DexmedetomidineContinuous intravenous administration with a loading dose of 0.05 μg/kg over 30 minutes followed by a maintenance dose (from 0.05 to 0.2 μg/kg/h) | Drug | Dexmedetomidine |
Primary outcome
Time, measured in minutes, is evaluated from the discontinuation of the experimental treatment (either dexmedetomidine-based or midazolam-based sedation) to extubation.
Time frame: from the discontinuation of the experimental treatment to extubation (48 maximum)
to compare the efficacy of dexmedetomidine-based sedation versus midazolam-based sedation in very preterm neonates.
6 secondary outcomes
Administration of Opioid Agents During Sedation with Dexmedetomidine or Midazolam in Neonatal Intensive Care.
Time frame: from the start of treatment (dexmedetomidine or midazolam) until extubation (16 days maximum)
Quality of sedation
Time frame: Before sedation, then every 30 min after sedation initiation, then every 3 hours after the initial 60 min, and up to 14 days
Extubation failure 24 hours after extubation
Time frame: In 24 hours after extubation
Withdrawal syndrome (Finnegan score >8).
Time frame: 6 hours, within 7 days after extubation.
Hemodynamic and respiratory adverse effects between inclusion and 84 hours after treatment discontinuation,
Time frame: From start of the sedation until 84 h after the sedative is stopped (maximum 18 days)
In hospital morbi mortality.
Time frame: the period of hospitalization and within the limit of 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clément CHOLLAT, Doctor principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Midazolam and Dexmedetomidine in people with PreTerm Neonate and Sedation for Invasive Mechanical Ventilation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clément CHOLLAT, MD, PhD, Associate Professor (+33 6 86 72 29 58, clement.chollat@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time, measured in minutes, is evaluated from the discontinuation of the experimental treatment (either dexmedetomidine-based or midazolam-based sedation) to extubation. (time frame: from the discontinuation of the experimental treatment to extubation (48 maximum)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.