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NCT04989790 · ClinicalTrials.gov registry record · NA
Clinical Effectiveness of the "PICU Up!" Multifaceted Early Mobility Intervention for Critically Ill Children
A NA study of Critical Illness and Child, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- NA
- Development phase
- 1,440
- Enrollment target
- 11
- Study locations
NCT04989790 is a NA study of Critical Illness and Child that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 1,440 participants, below the 3,123-participant average among 91 other Critical Illness trials with a reported enrollment target (54% lower). The trial reports 11 study locations across 11 states.
The verdict
NCT04989790, a NA study of Critical Illness and Child, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- NA
- Development phase
- 1,440 participants
- Enrollment target
- 11
- Study locations
Study Summary
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 v
Conditions Studied
Interventions
- OTHER PICU Up!
Study Locations (11)
California
- Valley Children's Hospital - Madera
Florida
- Nemours Children's Hospital of the Nemours Foundation - Orlando
Kentucky
- Norton Children's Hospital: University of Louisville - Louisville
Maryland
- Johns Hopkins Hospital - Baltimore
Minnesota
- Hennepin Healthcare: University of Minnesota - Minneapolis
New Hampshire
- Children's Hospital at Dartmouth: Geisel School of Medicine - Lebanon
North Carolina
- UNC Children's: University of North Carolina - Chapel Hill
Pennsylvania
- Janet Weis Children's Hospital: Geisinger Commonwealth School of Medicine - Danville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,440 participants |
| Start Date | 2022-08-08 |
| Est. Completion | 2026-09-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04989790
The ClinicalTrials.gov registry entry for NCT04989790 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 1,440 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,123-participant average among 91 other Critical Illness trials with a reported enrollment target (54% lower). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Critical Illness appearing as the primary indexed condition, and to 1 intervention - of which PICU Up! is the first listed.
NCT04989790 reports 11 study locations spanning 11 distinct geographic areas - top geographies include California, Florida, Kentucky.
Frequently Asked Questions
What is clinical trial NCT04989790 about?
NCT04989790 is a clinical study titled "Clinical Effectiveness of the "PICU Up!" Multifaceted Early Mobility Intervention for Critically Ill Children". 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 venti...
What is the current status of trial NCT04989790?
This trial is currently recruiting. It is a NA study. The enrollment target is 1,440 participants. The study started on 2022-08-08. Estimated completion is 2026-09-30.
What conditions does trial NCT04989790 study?
This clinical trial studies the following conditions: Critical Illness, Child, Intensive Care Unit Acquired Weakness, Hospital Acquired Pressure Ulcer.
What interventions are being tested in trial NCT04989790?
The interventions under investigation include: PICU Up! (OTHER).
Who is sponsoring clinical trial NCT04989790?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04989790 being conducted?
This trial has 11 study locations across California, Florida, Kentucky, Maryland, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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