Status:
ACTIVE_NOT_RECRUITING
PICU Up!: A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Donaghue Medical Research Foundation
Conditions:
Critical Illness
Eligibility:
All Genders
Up to 24 years
Phase:
NA
Brief Summary
Recent decreases in Pediatric Intensive Care Unit (PICU) mortality rates have been offset by increased morbidity and length of stay for vulnerable young patients. Heavy sedation, bedrest, and delirium...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Participating Units:
- Participating PICUs must be a separate physical space dedicated to the care of critically ill infants and children, with the ability to provide mechanical ventilation.
- Not implemented a PICU mobility protocol and would commit to not implementing a mobility protocol until the randomized time of unit implementation.
- Inclusion Criteria for Patients:
- All patients admitted to the PICUs regardless of length of stay will receive the unit-based PICU Up! intervention, which includes criteria for no mobilization based on specific clinical factors (i.e. open chest, surgeon request).10 For inclusion in data analysis, patients will be eligible if
- Admitted to the participating PICU ≥ 3 days.
- Exclusion Criteria for Patients:
- Patients with an active do-not-resuscitate (DNR) order will be excluded.
Exclusion
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
2500 Patients enrolled
Trial Details
Trial ID
NCT03860168
Start Date
April 1 2019
End Date
May 31 2026
Last Update
December 22 2025
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287