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Efficacy of dexmedetomidine versus midazolam sedation on extubation time in mechanically ventilated preterm infants: a randomized controlled multicenter trial (DEXPRE)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508785-16-00
Acronym
APHP230813
Enrollment
380
Registered
2024-08-23
Start date
2025-10-17
Completion date
Unknown
Last updated
2025-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Very preterm neonate (gestational age at birth < 32 WG) with corrected gestational age <45 WG) with indication for sedation in the context of invasive mechanical ventilation

Brief summary

Time-to-extubation after discontinuation of dexmedetomidine-based sedation versus discontinuation of midazolam-based sedation in very preterm neonates.

Detailed description

Administration of opioid agents during the period of interest, i.e., from the start of treatment (DEX or midazolam) until extubation, Time (in hours) between start of sedation and achievement of a normal Comfort B score (ie. between 11 and 17)., Intubation rate at 24 hours after extubation., Proportion of patients with at least one value of the Finnegan score > 8 from within 3 days after extubation., Hemodynamic and respiratory adverse event from start of the sedation until 84 h after the sedative is stopped defined as: bradycardia, hemodynamic instability, desaturation <85% despite optimization of mechanical ventilation, reintubation, In-hospital mortality, Severe neonatal morbidity

Interventions

DRUGMIDAZOLAM
DRUGsolution à diluer pour perfusion

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Time-to-extubation after discontinuation of dexmedetomidine-based sedation versus discontinuation of midazolam-based sedation in very preterm neonates.

Secondary

MeasureTime frame
Administration of opioid agents during the period of interest, i.e., from the start of treatment (DEX or midazolam) until extubation, Time (in hours) between start of sedation and achievement of a normal Comfort B score (ie. between 11 and 17)., Intubation rate at 24 hours after extubation., Proportion of patients with at least one value of the Finnegan score > 8 from within 3 days after extubation., Hemodynamic and respiratory adverse event from start of the sedation until 84 h after the sedative is stopped defined as: bradycardia, hemodynamic instability, desaturation <85% despite optimization of mechanical ventilation, reintubation, In-hospital mortality, Severe neonatal morbidity

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026