Trial · NCT07542990
Impact on Delirium of the Use of DEXmedetomidine as First-line Sedation in PEDIAtric Intensive Care
NCT07542990, Phase 3, Not yet recruiting, University Hospital, Tours
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Impact on Delirium of the Use of DEXmedetomidine as First-line Sedation in PEDIAtric Intensive Care. Trials, record NCT07542990. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07542990
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Impact on Delirium of the Use of DEXmedetomidine as First-line Sedation in PEDIAtric Intensive Care
- NCT number
- NCT07542990
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 266 participants, estimated
- Lead sponsor
- University Hospital, Tours
- Conditions
- Delirium in the Intensive Care Unit
- Interventions
- Dexmedetomidine, Midazolam
- First posted
- 2026-04-21
- Last updated
- 2026-09-28
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of children with at least one episode of delirium during the ICU stay. | From enrollment to the end of ICU stay, up to 90 days | Surveillance of delirium is part of the routine neurological monitoring in pediatric ICU. CAPD score is an 8-items scale. A score of 9 points or higher indicates the presence of delirium. We will evaluate the proportion of children with at least one CAPD score higher than 9. |
| Secondary | Sedation efficacy | From enrollment to the end of sedation, up to 90 days | Investigators will assess: * The percentage of sedation scores in the target sedation range evaluated with COMFORT B scale every 4 hours, in each group * Percentage of under-sedation, and adverse events (such as unplanned extubation with reintubation, accidental removal of a central line) * Percentage of over-sedation |
| Secondary | Duration of delirium | from enrollment to the end of ICU stay, up to 90 days | Investigators will assess the number of days with CAPD score higher than or equal to 9 |
| Secondary | Adverse events and serious adverse events | From enrollment to the end of ICU stay, up to 90 days | Investigators will record: * Hypotension and/or bradycardia needing an intervention, unplanned extubation * accidental removal of a central line |
| Secondary | Mechanical ventilation | From enrollment to extubation, for an average of 7 days | Investigators will report the mechanical ventilation time in hours |
| Secondary | Health economic end points | From enrollment to the end of hospital stay, up to 90 days | Investigators will assess the cumulative doses of IV sedative and analgesic drugs so we can compare: * Difference in the costs of sedative, analgesics and opioids consumed during the paediatric intensive care stay and valued from the hospital perspective; * Difference in the cost of inpatient stays and the cost of stays in intensive care units valued from the healthcare system perspective, over a three month time horizon. |
| Secondary | Severity of delirium | from enrollement to the end of hospital stay, up to 90 days | Investigators will assess the severity of delirium defined by the need for antipsychotic drugs |
| Secondary | Need for re-intubation | from enrollment, to the end of hospital stay, up to 90 days | Investigators will report the need for re-intubation post extubation |
| Secondary | Need for neurological investigations | from enrollement to the end of hospital stay, up to 90 days | Investigators will report the percentage of brain imaging and electroencephalogramm |
| Secondary | Length of stay | from enrollement to the end of hospital stay, up to 90 days | Investigators will report * Intensive care unit length of stay, in days * Hospital length of stay out of the intensive care unit, in days |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 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/NCT07542990
GET https://conductscience.org/api/trials/v1/NCT07542990/registered