Trial · NCT07542990
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| 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 |
| Secondary | Mortality | from enrollement, to the end of follow-up, up to 90 days | Investigators will assess: hospital mortality |
| Secondary | Withdrawal | from enrollement to the end of ICU stay, up to 90 days | Investigators will assess the incidence of iatrogenic withdrawal syndrome, measured with WAT-score (defined by WAT \> 4) |
| Secondary | Associated sedation | from enrollement, to the end of sedation, up to 90 days | Investigators will assess the daily cumulative weight-adjusted dose of IV sedative agents (benzodiazepine, ketamine, propofol) and opioids required in each group. |
| Secondary | Duration of sedation | from enrollment, to the end of sedation, up to 90 days | Invesitgators will assess the number of days exposed to sedatives and opioids |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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