Dexmedetomidine for Preterm infant requiring sedation during invasive mechanical ventilation (very preterm neonate, gestational age at birth <32 weeks; corrected gestational age <45 weeks)

Inclusion criteria

• {"criterion_text":"- Patient admitted in NICU\n- Randomization criteria 2 : elective sedation (acceptable delay between the decision to sedate and the administration of the sedative agent),\n- Randomization criteria 3 : presence or plan of a venous access,\n- Randomization criteria 4 : no medical contraindication related to the administration of dexmedetomidine or midazolam,\n- Holder(s) of parental authority must sign the written or electronic informed consent\n- Holder(s) of parental authority must sign the written or electronic informed consent\n- Randomization criteria 5 : no concomitant use of curare agent\n- randomization criteria 6 : no previous extubation within 7 days\n- Randomization criteria 7 : no Clonidine treatment\n- randomisation criteria 7 : no hemodynamic instability\n- randomisation criteria 8 : no palliative care\n- Gestational age at birth < 32 weeks of gestation (WG),\n- Corrected gestational age <45 weeks of gestation (WG)\n- Randomization criteria 1 : indication for sedation in the context of invasive mechanical ventilation"}

Exclusion criteria

• {"criterion_text":"- Polymalformative syndrome\n- Palliative care,\n- Inclusion in another clinical trial on medicinal products, clinical investigation protocol concerning a medical device or interventional protocol not concerning a health product.\n- Clonidine treatment\n- Parents who don't understand French"}

Primary endpoints

• {"endpoint_text":"- Time-to-extubation after discontinuation of dexmedetomidine-based sedation versus discontinuation of midazolam-based sedation in very preterm neonates.","definition_or_measurement_approach":"Time from discontinuation of the sedative (dexmedetomidine or midazolam) to extubation; time-to-event (time-to-extubation) comparison between arms."}

Secondary endpoints

• {"endpoint_text":"- Administration of opioid agents during the period of interest, i.e., from the start of treatment (DEX or midazolam) until extubation","definition_or_measurement_approach":"Binary/proportion or count of opioid agents administered between treatment start and extubation; measured from treatment start to extubation."}
• {"endpoint_text":"- Time (in hours) between start of sedation and achievement of a normal Comfort B score (ie. between 11 and 17).","definition_or_measurement_approach":"Time in hours from sedation start to first recorded Comfort B score between 11 and 17."}
• {"endpoint_text":"- Intubation rate at 24 hours after extubation.","definition_or_measurement_approach":"Proportion of patients requiring intubation within 24 hours post-extubation."}
• {"endpoint_text":"- Proportion of patients with at least one value of the Finnegan score > 8 from within 3 days after extubation.","definition_or_measurement_approach":"Proportion of patients with any Finnegan score >8 within 3 days following extubation."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Occurrence of predefined hemodynamic/respiratory adverse events (bradycardia, hemodynamic instability, desaturation <85% despite optimization, reintubation) from sedation start until 84 hours after sedative stop."}
• {"endpoint_text":"- In-hospital mortality","definition_or_measurement_approach":"Death occurring during the index hospitalization."}
• {"endpoint_text":"- Severe neonatal morbidity","definition_or_measurement_approach":"Proportion or incidence of predefined severe neonatal morbidity events (as defined in protocol); specific definition not provided in the available source."}

France

Earliest CTIS Part Ii Submission Date

12-08-2024

Latest Decision Or Authorization Date

02-12-2025

Processing Time Days

477

Number Of Sites

12

Number Of Participants

380

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France