Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 15 of 15

List	Outcome	Time frame	Description
Primary	Participant recruitment	2 years	Accrual and/or identification of challenges in accruing 60 mechanically ventilated participants (age 1 month to 18 years).
Secondary	Protocol adherence	28 days	The frequency (%) of randomized patients who remain within their designated trial arm and cross-overs. Cross overs may occur from i) drug allergy (rare \<0.1%), ii) clinical reason, iii) equipment issues, and iv) health team discomfort using a new intervention.
Secondary	Attrition	3 years	The frequency (%) of randomized patients who are lost to follow up prior to completion of all study outcome measures and the reasons for no follow-up will be documented. Expected loss to follow-up can occur due to i) inter-facility transfers, ii) patient/family withdrawal from the trial, iii) lack of interest in long-term follow-up.
Secondary	Safety/adverse event rate	From date of consent until the date of resolution or date of death from any cause, whichever came first, assessed up to 13 months	Adverse events that are assess as related (possibly, probably or definitely) to study intervention, standard of care, or study equipment will be reported. Adverse events that are assess as unrelated to study intervention, standard of care or study equipment will not be reported. Adverse events will be captured from the time of consent until the time of study completion.
Secondary	Healthcare team satisfaction	Study days 1, 2 & 3	All health team members (physicians, nurses and respiratory therapists) will be surveyed daily for up to 3 days in both study arms using a 5-point Likert scale satisfaction score. Free text comments will be allowed to better understand barriers and facilitators.
Other	Feasibility of collecting delirium scores	28 days	Proportion of participants who complete delirium (Cornell Assessment of Pediatric Delirium (CAPD)) and coma (Richmond Agitation Sedation Scale (RASS) or COMFORT Behavioural Scale (COMFORT-B)) assessments twice a day.
Other	Delirium-free Coma-free days	28 days	The number of full days participants do not experience coma or delirium as assessed by RASS or COMFORT-B for coma and CAPD for delirium.
Other	Anti-psychotic drug use	28 days	The administration of anti-psychotic drugs will be captured from baseline until day 28.
Other	Sedative drug use	28 days	The administration of sedative drugs will be captured from baseline until day 28.
Other	Blood collection to assess biological markers of delirium, inflammation and brain injury	Study days 1, 2 & 3	Participants over \>2 years old will be able to participate in an optional blood collection sub-study that will look at 60 markers of delirium, inflammation and brain injury.
Other	Feasibility of neurocognitive assessment	1-year post enrollment	Proportion of participants who complete 12 month neurocognitive assessment
Other	Neurocognitive scores	1-year post enrollment	Assessment of scores from age-appropriate neurocognitive tests completed at 12-months post enrollment
Other	In-hospital mortality	1 year	Participant survival status will be captured daily for 28 days and reported at hospital discharge
Other	Ventilator-free days	28 days	The use of a ventilator will be captured from baseline until day 28. The number of days a participant does not require a ventilator will be computed.
Other	ICU-free days	28 days	ICU discharge date will be captured and compared to admission date to determine number of days the participant was not in the ICU up to 28 days.

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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