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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Mar 10, 2025

Keywords

ClinConnect Summary

The DEXPRE trial is studying the effectiveness of two different medications, dexmedetomidine (DEX) and midazolam, used to sedate very preterm infants (those born before 32 weeks of pregnancy) who need help breathing through a machine called invasive mechanical ventilation (IMV). This trial aims to find out which medication helps these fragile infants get off the ventilator faster and have better breathing outcomes. DEX is thought to be a better option because it can provide sedation without causing as much trouble with breathing as midazolam, which is commonly used but has potential side effects.

To participate in this trial, infants must be admitted to the neonatal intensive care unit (NICU) with a gestational age of less than 32 weeks and a corrected age of less than 45 weeks. Parents will need to give their consent for their child to be part of the study. During the trial, participants will receive either DEX or midazolam for sedation, and researchers will monitor how well they respond to the sedation, how quickly they can be safely removed from the ventilator, and any side effects that may occur. This study is important as it could help improve the care and outcomes for very preterm infants who require intensive respiratory support.

Gender

ALL

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.