Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT06878703
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.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
32 Weeks
Study:
NCT06878703
Study Brief:
Protocol Section:
NCT06878703