# Clinical Effectiveness of the "PICU Up!" Multifaceted Early Mobility Intervention for Critically Ill Children:  A pragmatic, stepped-wedge trial

> **NIH NIH R01** · JOHNS HOPKINS UNIVERSITY · 2024 · $589,401

## Abstract

PROJECT 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. Our prior
studies revealed that <10% 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, we 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. We have demonstrated the safety and feasibility of this pragmatic, multifaceted strategy
in both single-site and multicenter pilot studies. Hence, the next phase of our research is to evaluate the
clinical effectiveness and delivery of the PICU Up! intervention across a range of PICU patients and health
systems.
We propose a pragmatic, stepped-wedge, cluster randomized controlled trial that will include 10 academic
and community hospitals in the United States (1,440 patients), with the following Aims: 1) Evaluate if the
PICU Up! intervention, delivered under real-world conditions, decreases mechanical ventilation duration
(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.

## Key facts

- **NIH application ID:** 10852829
- **Project number:** 5R01HD103811-04
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** SAPNA R KUDCHADKAR
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $589,401
- **Award type:** 5
- **Project period:** 2021-06-08 → 2026-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10852829

## Citation

> US National Institutes of Health, RePORTER application 10852829, Clinical Effectiveness of the "PICU Up!" Multifaceted Early Mobility Intervention for Critically Ill Children:  A pragmatic, stepped-wedge trial (5R01HD103811-04). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10852829. Licensed CC0.

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