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
Conditions
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
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time-to-extubation after discontinuation of dexmedetomidine-based sedation versus discontinuation of midazolam-based sedation in very preterm neonates. | — |
Secondary
| Measure | Time 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