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Clinical Effectiveness of the "PICU Up!" Multifaceted Early Mobility Intervention for Critically Ill Children

Study acronym: PICU Up!
StatusCompleted
PhaseNot applicable
Started2022-08-08
View on ClinicalTrials.gov ↗

Amendment history

2026-10-02
critical
Trial completed
Primary endpoint(s) modified1 entry, revised
WasDuration of Mechanical Ventilation
NowDays Alive and Ventilator-Free (AVF)
Study completion confirmed: August 2025 (last estimated September 2026)
Results posted: 2026-10-01
2026-08-10
minor
Study Status v13
Re-verified, no change to tracked fields
2026-03-16
minor
Study Status v12
Completion date2026-03-31→2026-09-30
2025-08-15
minor
Study Status v11
Primary completion dateestimated 2025-08-31→confirmed 2025-08-11
2025-04-10
minor
Study Identification, Study Status v10
Primary completion date2025-04-30→2025-08-31
Show 9 earlier versions
2024-12-10
minor
Study Status v9
Primary completion date2024-12-31→2025-04-30
2024-04-11
minor
Study Status v8
Primary completion date2024-12→2024-12-31
Completion date2026-03→2026-03-31
2023-09-12
minor
Study Status v7
Re-verified, no change to tracked fields
2022-09-09
minor
Study Status, Contacts/Locations v6
Study sitescontacts updated at 1 of 11 sites
2022-08-12
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v5
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-08→confirmed 2022-08-08
Study sitesdetails revised at 11 of 11 sites
2022-07-06
minor
Study Status v4
Start date2022-07→2022-08
2022-06-27
minor
Study Status v3
Start date2022-06→2022-07
2021-08-16
minor
Study Status, Arms and Interventions, Outcome Measures v2
Re-verified, no change to tracked fields
2021-08-13
minor
Study Status, Outcome Measures, Contacts/Locations v1
Secondary endpointsdetails revised at 2 of 3 entries
Study sitescontacts updated at 10 of 11 sites
2021-07-26
minor
Original filing
While mortality in U.S. pediatric intensive care units (PICUs) is improving, surviving children frequently develop persistent physical, cognitive, and psychological impairments. Over half of critically ill children experience potentially preventable PICU-acquired morbidities, with mechanically ventilated children being at greatest risk. In critically ill adults, randomized trials have shown that progressive mobility, started early (within 3 days of initiating mechanical ventilation), decreases muscle weakness and the duration of mechanical ventilation. However, similar randomized studies have not been conducted in the PICU. The investigator's prior studies revealed that less than 10 percent of critically ill children at the highest risk of functional decline are evaluated by a physical or occupational therapist within 3 days of PICU admission. Given the interplay of sedation, delirium, sleep, and immobility in the PICU, single-component interventions, such as sedation protocolization, have not consistently shown benefit for decreasing mechanical ventilation duration. Thus, the investigators developed the first pediatric-specific, interprofessional intervention (PICU Up!) to integrate goal-directed sedation, delirium prevention, sleep promotion, and family engagement into daily PICU care in order to facilitate early and progressive mobility. The investigators have demonstrated the safety and feasibility of this pragmatic, multifaceted strategy in both single-site and multicenter pilot studies. Hence, the next phase of the investigators research is to evaluate the clinical effectiveness and delivery of the PICU Up! intervention across a range of PICU patients and health systems. The investigators propose a pragmatic, stepped-wedge, cluster randomized controlled trial that will include 10 academic and community hospitals in the United States, with the following Aims: 1) Evaluate if the PICU Up! intervention, delivered under real-world conditions, decreases mechanical ventilation duration, measured as days alive and ventilator-free (AVF) through Day 21 (primary outcome) and improves delirium and functional status compared to usual care in critically ill children; and 2) Conduct a multi-stakeholder, mixed-methods process evaluation to identify key contextual factors associated with delivery of PICU Up!. If proven effective, the PICU Up! intervention has potential to profoundly change medical care in the PICU and substantially impact public health by improving outcomes for the growing number of pediatric survivors of critical illness.
Trial Details
NCT Number NCT04989790
Lead Sponsor Johns Hopkins University
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions Child, Intensive Care Unit Acquired Weakness, Critical Illness, Hospital Acquired Pressure Ulcer
Enrollment 1,470 participants
Start Date 2022-08-08
Primary Completion 2025-08-11 (estimated)
Study Completion 2025-08-11 (estimated)
Updated on ClinicalTrials.gov 2026-10-01