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Efficacy of Dexmedetomidine Versus Midazolam Sedation on Extubation Time in Mechanically Ventilated Preterm Infants

RecruitingPhase 3Ages any - 32 WeeksAllAssistance Publique - Hôpitaux de Paris
NCT06878703 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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). Al

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📋 Eligibility rules (as published)
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.
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What it tests

  • Midazolam
  • Dexmedetomidine
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Where

1 site
Hospital Armand Trousseau, APHP Service : Department of Neonatology
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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