NCT06878703 Efficacy of Dexmedetomidine Versus Midazolam Sedation on Extubation Time in Mechanically Ventilated Preterm Infants
| NCT ID | NCT06878703 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | PreTerm Neonate |
| Study Type | INTERVENTIONAL |
| Enrollment | 380 participants |
| Start Date | 2025-10-16 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 380 participants in total. It began in 2025-10-16 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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, * 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, Exclusion Criteria: * 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.
Contact & Investigator
Clément CHOLLAT, Doctor
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT06878703 clinical trial?
This trial is open to participants of all sexes, up to 32 Weeks, studying PreTerm Neonate. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06878703 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 380 participants.
Is NCT06878703 currently recruiting?
Yes, NCT06878703 is actively recruiting participants. Contact the research team at clement.chollat@aphp.fr for enrollment information.
Where is the NCT06878703 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06878703 clinical trial?
NCT06878703 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Clément CHOLLAT, Doctor at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 380 participants.