Status:
COMPLETED
Restore Resilience in Critically Ill Children
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Johns Hopkins University
Children's Hospital of Philadelphia
Conditions:
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
6-17 years
Phase:
NA
Brief 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...
Detailed Description
Hospitals should do the sick no harm. That noted, modern day pediatric intensive care units (PICUs) are not healing milieus. Immediately upon admission to the PICU, the child's daily routine and sleep...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04695392
Start Date
September 5 2017
End Date
December 31 2021
Last Update
April 30 2024
Active Locations (2)
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1
Johns Hopkins University - Charlotte Bloomberg Children's Center
Baltimore, Maryland, United States, 21287
2
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104