2023-508785-16-00
Not yet recruiting
Phase 3
Efficacy of dexmedetomidine versus midazolam sedation on extubation time in mechanically ventilated preterm infants: a randomized controlled multicenter trial (DEXPRE)
Assistance Publique Hopitaux De Paris9 sites in 1 country380 target enrollmentStarted: August 23, 2024Last updated:
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 380
- Locations
- 9
- Primary Endpoint
- Time-to-extubation after discontinuation of dexmedetomidine-based sedation versus discontinuation of midazolam-based sedation in very preterm neonates.
Overview
Brief Summary
To compare the efficacy of dexmedetomidine-based sedation versus midazolam-based sedation in very preterm neonates.
Eligibility Criteria
- Ages
- 0 years to 17 years (0-17 Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patient admitted in NICU
- •Randomization criteria 2 : elective sedation (acceptable delay between the decision to sedate and the administration of the sedative agent),
- •Randomization criteria 3 : presence or plan of a venous access,
- •Randomization criteria 4 : no medical contraindication related to the administration of dexmedetomidine or midazolam,
- •Holder(s) of parental authority must sign the written or electronic informed consent
- •Holder(s) of parental authority must sign the written or electronic informed consent
- •Randomization criteria 5 : no concomitant use of curare agent
- •randomization criteria 6 : no previous extubation within 7 days
- •Randomization criteria 7 : no Clonidine treatment
- •randomisation criteria 7 : no hemodynamic instability
Exclusion Criteria
- •Polymalformative syndrome
- •Palliative care,
- •Inclusion in another clinical trial on medicinal products, clinical investigation protocol concerning a medical device or interventional protocol not concerning a health product.
- •Clonidine treatment
- •Parents who don't understand French
Outcomes
Primary Outcomes
Time-to-extubation after discontinuation of dexmedetomidine-based sedation versus discontinuation of midazolam-based sedation in very preterm neonates.
Time-to-extubation after discontinuation of dexmedetomidine-based sedation versus discontinuation of midazolam-based sedation in very preterm neonates.
Secondary Outcomes
- 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
Investigators
Dr Clément CHOLLAT
Scientific
Assistance Publique Hopitaux De Paris
Study Sites (9)
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