Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2025-12-24 @ 3:21 PM
NCT ID:
NCT04695392
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
17 Years
Study:
NCT04695392
Study Brief:
Protocol Section:
NCT04695392