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Compares treatment options for PreTerm Neonate
Official title Efficacy of Dexmedetomidine Versus Midazolam Sedation on Extubation Time in Mechanically Ventilated Preterm Infants
ClinicalTrials.gov ID: NCT06878703
What this study is testing
What is Midazolam?
Midazolam is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for preterm neonate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Very preterm neonates (born before 32 weeks' gestation) often require invasive mechanical ventilation (IMV) to manage respiratory insufficiency. In France, around 8,250 infants are born annually at \<32 weeks, with an estimated 5,000 needing IMV.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 32
You may be able to join if
- 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,
You likely can't join if
- 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.
See the full eligibility 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,
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 32 weeks. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.