Trial · NCT06878703
Efficacy of Dexmedetomidine Versus Midazolam Sedation on Extubation Time in Mechanically Ventilated Preterm Infants
NCT06878703, Phase 3, Recruiting, Assistance Publique - Hôpitaux de Paris
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Dexmedetomidine Versus Midazolam Sedation on Extubation Time in Mechanically Ventilated Preterm Infants. Trials, record NCT06878703. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06878703
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Dexmedetomidine Versus Midazolam Sedation on Extubation Time in Mechanically Ventilated Preterm Infants
- NCT number
- NCT06878703
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 380 participants, estimated
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Conditions
- PreTerm Neonate, Sedation for Invasive Mechanical Ventilation, Very Preterm Neonates With Sedation for Invasive Mechanical Ventilation
- Interventions
- Midazolam, Dexmedetomidine
- First posted
- 2025-03-17
- Last updated
- 2026-02-10
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time, measured in minutes, is evaluated from the discontinuation of the experimental treatment (either dexmedetomidine-based or midazolam-based sedation) to extubation. | from the discontinuation of the experimental treatment to extubation (48 maximum) | to compare the efficacy of dexmedetomidine-based sedation versus midazolam-based sedation in very preterm neonates. |
| Secondary | Administration of Opioid Agents During Sedation with Dexmedetomidine or Midazolam in Neonatal Intensive Care. | from the start of treatment (dexmedetomidine or midazolam) until extubation (16 days maximum) | Administration of opioid agents during the period of interest, i.e., from the start of treatment (DEX or midazolam) until extubation (total cumulative dose and morphine equivalents in mg/kg, duration). opioids include morphine (1), fentanyl (0.010), remifentanil (0.15), sufentanil (0.003) and methadone (0.3). |
| Secondary | Quality of sedation | Before sedation, then every 30 min after sedation initiation, then every 3 hours after the initial 60 min, and up to 14 days | Time (in hours) between start of sedation and achievement of a normal Comfort B score (ie. between 11 and 17), |
| Secondary | Extubation failure 24 hours after extubation | In 24 hours after extubation | Intubation proportion at 24 hours after extubation. |
| Secondary | Withdrawal syndrome (Finnegan score >8). | 6 hours, within 7 days after extubation. | Proportion of patients with at least one value of the Finnegan score \> 8 from within 3 days after extubation. |
| Secondary | Hemodynamic and respiratory adverse effects between inclusion and 84 hours after treatment discontinuation, | From start of the sedation until 84 h after the sedative is stopped (maximum 18 days) | * Bradycardia defined by heart rate \< 80 bpm considered as clinically significant by the treating physician, despite optimization of hemodynamic management * Hemodynamic instability defined by a mean blood pressure below corrected GA, or a skin recoloration time \> 3 seconds despite optimization of haemodynamic management * Desaturation \<85% despite optimization of mechanical ventilation * Reintubation |
| Secondary | In hospital morbi mortality. | the period of hospitalization and within the limit of 24 months | Severe neonatal morbidity as : * late onset sepsis defined by a positive blood culture and antibiotic therapy more than 72 hours, * necrotizing enterocolitis according to Bell's definition61 * moderate (fraction of inspired oxygen (FiO2) \<30%) and severe (FiO2 ≥30%) bronchopulmonary dysplasia at 36 WG defined by need of IMV, nasal continuous positive airway pressure, or nasal cannula at 36 weeks postmenstrual age, according to Jobe's definition * retinopathy of prematurity is diagnosed at the fundus performed systematically before discharge, intraventricular hemorrhage diagnosed on routine transfontanelar ultrasound, according to Papile classification |
| Other | Exploratory outcome: Duration (in hours) of invasive mechanical ventilation from intubation to extubation | From intubation to extubation | To assess the impact of the treatment on Duration of mechanical ventilation |
| Other | Exploratory outcome: Length of stay in the NICU | Within the limit of 24 months | |
| Other | Exploratory outcome: : Short-term clinical outcomes | at 36 Week of Gestation | Survival without moderate and severe bronchopulmonary dysplasia at 36 WG, |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06878703
GET https://conductscience.org/api/trials/v1/NCT06878703/registered