Studying the Impact of the PICU Up Early Mobility Program on Recovery of Critically Ill Children on Mechanical Ventilation
Led by Johns Hopkins University · Updated on 2026-03-18
1440
Participants Needed
11
Research Sites
59 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of the PICU Up intervention, a multifaceted early mobility program, for critically ill children in pediatric intensive care units PICUs. The study aims to see if this approach can reduce the duration of mechanical ventilation and improve delirium and functional outcomes compared to usual care. The trial focuses on children at risk of functional decline, particularly those on mechanical ventilation, addressing challenges such as sedation, delirium, and immobility that affect recovery.
The PICU Up intervention integrates goal-directed sedation, delirium prevention, sleep promotion, and family engagement into daily care. It uses a tiered activity plan tailored to each childs needs, with the care team setting daily mobility goals during rounds. The intervention includes analgesia management, extubation readiness testing, sedation and delirium monitoring, early physical and occupational therapy consultation by PICU Day 3, sleep support, and family involvement. The study compares usual PICU care with this structured intervention across multiple hospitals.
Participants will be critically ill children requiring invasive mechanical ventilation for at least 48 hours by PICU Day 3. Researchers will assess mechanical ventilation duration, delirium days, and functional status changes using standardized pediatric scales through Day 21. The study also includes a process evaluation to understand factors affecting intervention delivery. Participants care, safety, and outcomes will be closely monitored throughout the trial, which is expected to continue until 2026.
CONDITIONS
Brief Title
Clinical Effectiveness of the "PICU Up!" Multifaceted Early Mobility Intervention for Critically Ill Children
Research Team
S
Sapna R Kudchadkar, MD, PhD
C
Colleen Mennie, RN
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
How This Trial Compares With Other Options
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
PICU Up! Early Mobility
Usual Care Before PICU Up!
What it is
A multifaceted early mobility intervention (PICU Up!) that individualizes activity plans and integrates mobility goals into daily multidisciplinary rounds for all PICU patients.
Routine clinical management for critically ill children in the PICU, without a structured formal mobility protocol integrated into daily rounds.
Role in the study
Served as the intervention period after the introduction of the PICU Up! early mobility program within the PICU.
Served as the baseline comparison period, representing the usual care before any specialized early mobility processes were instituted.
Primary use or purpose
Designed to increase early mobility and decrease mechanical ventilation duration, delirium, and ICU-acquired weakness through integrated mobility planning and daily team rounds.
Provided standard monitoring, ventilation, sedation, and critical care using prevailing practice, not focused on early mobility.
How it is given or performed
A daily multidisciplinary team meeting established each patient's individualized mobility level, documented mobility goals in rounds, encouraged early PT/OT consultation, addressed sedation, delirium, and included family participation in mobility.
Care decisions were made according to each unit's standard protocols, without a structured early-mobility checklist or daily multidisciplinary mobility goal-setting.
Evidence status
Early mobility programs like PICU Up! have shown feasibility and increased mobilization in critically ill children. Broader adoption may improve duration of mechanical ventilation, reduce ICU-acquired weakness, and address pediatric delirium risk, but evidence for patient-centered outcomes continues to evolve.
Usual care varies by institution and has historically not routinely included consistent early mobility efforts in the PICU. Prior studies show limited adoption of formal mobility protocols in pediatric critical care.
Important limitations
Implementation may require significant workflow change, training, and support from multidisciplinary teams. Further study is needed to establish impact on key outcomes like mechanical ventilation duration and long-term function.
May miss opportunities to promote functional recovery and reduce delirium because standard care often lacks focused early mobility planning for children in the PICU.
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 0 - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
Invasive mechanical ventilation via oral or nasal endotracheal tube for at least 48 hours at 7 a.m. on PICU Day 3
You will not qualify if you...
Active or anticipated withdrawal of life support within 48 hours
Open chest or open abdomen
Current use of Extracorporeal Membrane Oxygenation (ECMO)
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Through Day 21
Participants receive usual PICU care or the PICU Up! early mobility intervention integrated into routine PICU practice to promote safe, early, and progressive mobility tailored to each child's needs.
Daily rounds during PICU stay
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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Published Research Related To This Trial
Impact of a multifaceted early mobility intervention for critically ill children - the PICU Up! trial: study protocol for a multicenter stepped-wedge cluster randomized controlled trial.
Razvan Azamfirei, Colleen Mennie, Victor D Dinglas...