Status:
NOT_YET_RECRUITING
Efficacy of Dexmedetomidine Versus Midazolam Sedation on Extubation Time in Mechanically Ventilated Preterm Infants
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Dr DATA
Conditions:
PreTerm Neonate
Sedation for Invasive Mechanical Ventilation
Eligibility:
All Genders
Up to 32 years
Phase:
PHASE3
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 \<...
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 ven...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2029
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT06878703
Start Date
September 15 2025
End Date
December 15 2029
Last Update
August 14 2025
Active Locations (1)
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1
Hospital Armand Trousseau, APHP Service : Department of Neonatology
Paris, France, 75012