Trial · NCT04684238
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Time of Adequately Maintained Sedation Depth up to 48 Hours (± 6 Hours) | Minimum of 12 hours up to 48 hours (± 6 hours). | Percentage of time of adequately maintained sedation within the COMFORT-B interval (light, moderate or deep sedation) prescribed at randomisation, monitored every 2 h for a minimum of 12 h (up to 48 h ± 6 h) |
| Secondary | Compare the Use of Opioids | From first blinded COMFORT-B assessment (at +2 h from start of study drug initiation) to end of the study treatment period | Dose of opioids from first blinded COMFORT-B assessment (at +2 h from start of study drug) to end of study treatment period. This was a key secondary efficacy endpoint. Dose of opioids was expressed as fentanyl IV equivalents. |
| Secondary | Compare the Use of Opioids | Last 4 hours of study treatment compared to first 4 hours of study treatment after first blinded COMFORT-B assessment (at +2 h from start of study drug initiation). | Dose of opioids during the last 4 h of study treatment, as compared to the first 4 h of study treatment after first blinded COMFORT-B assessment. This was a key secondary efficacy endpoint. Dose of opioids is expressed as fentanyl IV equivalents. |
| Secondary | Compare Time From End of Study Drug Administration to Extubation | From end of study drug administration to extubation or end of extubation attempt | Time from end of study drug administration to extubation if study drug was terminated for extubation |
| Secondary | Compare the Proportion of Time With Spontaneous Breathing | From initiation of study drug treatment to End of study treatment (up to 48h +/- 6h) | Proportion of observations with spontaneous breathing efforts during study treatment. This was a key secondary safety endpoint. |
| Secondary | Evaluate Haemodynamic Effect as Indicated by Need for Additional Inotropic/Vasopressor Agent | From start of study treatment to end of study treatment (up to 48h +/- 6h) | Need for additional inotropic/vasopressor agent defined by change in Vasoactive-Inotropic Score (VIS) during study treatment period compared to baseline. The VIS quantifies the amount of cardiovascular support required by infants postoperatively according to the below calculation: VIS = dopamine (µg/kg/min) + dobutamine (µg/kg/min) + 100 × epinephrine (µg/kg/min) + 100 × norepinephrine (µg/kg/min) + 10 × milrinone (µg/kg/min) + 10,000 × vasopressin (U/kg/min). An increased VIS score correlates to an increase in inotropic/vasopressor agents. |
| Secondary | Evaluate the Number of Patients With Withdrawal Symptom | From > 96 hours sedation (including pre-study sedation period) until the end of the 48-hour post study treatment monitoring or ICU discharge, whichever comes first. | Evaluate the frequency of withdrawal symptoms in isoflurane- vs midazolam-treated patients according to SOS-PD. |
| Secondary | Evaluate the Frequency of Delirium | Patients admitted to the ICU ≥48 hours (including period prior to study enrolment) until the end of the 48-hour post study treatment monitoring or ICU discharge, whichever comes first. | Evaluate the frequency of delirium in isoflurane- vs midazolam-treated patients |
| Secondary | Evaluate the Frequency of Neurological Symptoms or Psychomotor Dysfunction | During study treatment and up to 48 hours after discontinuation of isoflurane and midazolam | Evaluate the frequency of neurological symptoms or psychomotor dysfunction during and up to 48 hours after discontinuation of isoflurane and midazolam treatment, and the association with duration of treatment, and total exposure (MAC hours and midazolam doses) over time. |
| Secondary | Compare the 30 Days/Hospital Mortality | From start of study treatment up to 30 days | Compare the 30 days/hospital mortality in isoflurane- vs midazolam-treated patients |
| Secondary | Compare Ventilator-free Days | From start of study treatment up to 30 days | Ventilator-free days at 30 days from start of study treatment period. |
| Secondary | Compare the Time in ICU/Hospital | From start of study treatment up to 30 days | Compare the time in ICU at 30 days from start of study treatment period. This was a secondary safety endpoint. Patients that were withdrawn prior to day 30 were excluded from the analysis. Patients who died before day 30 were not considered withdrawals. For these patients, the days in ICU until day of death were considered ICU days. |
| Secondary | Compare ICU-free Days | From start of study treatment up to 30 days | Compare ICU-free days up to 30 days in isoflurane- vs midazolam-treated patients. |
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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