Restore Resilience in Critically Ill Children (NCT04695392) | Clinical Trial Compass
CompletedNot Applicable
Restore Resilience in Critically Ill Children
United States56 participantsStarted 2017-09-05
Plain-language summary
The study design will allow investigators to describe usual care in each PICU and identify the facilitating and restraining factors impacting the implementation of R2 at each PICU. The purpose of this pilot study is to improve the care, environment, daily routine and sleep patterns of children in the PICU. The goal of this study is to learn what can be improved to support a critically ill child's healing and circadian rhythms.
Who can participate
Age range6 Months – 17 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* PICU admission at one of the study sites in which elements of R2 are typically but sporadically implemented
* Transferred to the PICU from another hospital unit/ward with ≤4 nights in the hospital (≤2 nights in PICU)
* Between the ages 6 months and 18 years at the time of enrollment (has not had their 18th birthday)
* Intubated and mechanically ventilated for acute airway or parenchymal disease within last 48 hours
* Expected to be intubated for more than 12 hours past enrollment
* Parent/Guardian providing consent, provides primary care for subject
Exclusion Criteria:
* A baseline cognitive dysfunction, measured by the Pediatric Cerebral Performance Category (PCPC ≥4)
* A history of an uncontrolled seizure disorder (seizure within past 3 months), cerebral hypertension, neuromuscular respiratory failure, ventilator dependence (excluding BiPAP or CPAP at night)
* A history of inability to tolerate bolus enteral feeds (full J-Tube fed patients)
* The presence of any of the following within 24 hours of admission:
* Modal pain scores greater than 4
* Persistent hypotension/hypertension unresponsive to standard therapies
* Use of High Frequency Oscillatory Ventilation or Extracorporeal Membrane Oxygenation
* Administered melatonin within the past week
* Has an active do-not-resuscitate plan
What they're measuring
1
DARE (Daytime Activity Ratio Estimate), Post Extubation
Timeframe: From immediately after endotracheal extubation to PICU discharge, assessed for up to 28 days