An interventional study of PICU Up! in Child, Intensive Care Unit Acquired Weakness and Critical Illness, sponsored by Johns Hopkins University. Completed at 11 sites in United States. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Health services research
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.
1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.
This study's enrollment of 1,470 is above the median of 90 across 926 interventional studies indexed under Critical Illness.
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Exclusion Criteria:
Usual PICU care
PICU Up! is a multifaceted, inter-professional pathway that is integrated into routine PICU practice to safely optimize early and progressive patient mobility.
Other: PICU Up!
PICU Up! incorporates the screening process for determining a patient's appropriate activity level into the daily rounding workflow for all PICU patients, with a tiered activity plan based on clinical parameters to individualize goals based on each child's unique needs. While the patient's PICU Up! level is based on objective criteria, the interprofessional team collectively determines the daily activity goal(s) through shared decision-making which is documented in the medical record on morning rounds. The intervention facilitates daily discussion of 1) analgesia; 2) extubation readiness testing; 3) sedation level and goal; 4) delirium screening and management; 5) mobility goal including physical and occupational therapy consultation by PICU Day 3; 6) sleep promotion; and 7) family engagement in mobility.
Days Alive and Ventilator-Free (AVF)
Number of days through Day 21 during which the participant is alive and free of invasive mechanical ventilation. A ventilator-free day is a calendar day during which the participant is alive and the endotracheal tube is absent for 24 continuous hours. For participants with a tracheostomy, unassisted breathing is considered ventilator-free; assisted ventilation is not.
Time frame: Through Day 21
Days Alive and Delirium- and Coma-Free (ADCF)
Number of days through Day 21 during which the participant is alive, without delirium, and coma-free for 24 continuous hours during a calendar day.
Time frame: Through Day 21
Days Alive and Coma-Free (ACF)
Number of days through Day 21 during which the participant was alive and coma-free for 24 continuous hours during a calendar day. Coma-free days are defined as days when all documented sedation scores are above the following thresholds: State Behavioral Scale (SBS) ≥ -1, Richmond Agitation-Sedation Scale (RASS) ≥ -3, or COMFORT-B ≥ 10, as applicable. Days following PICU discharge through Day 21 are considered alive and coma-free unless the participant is deceased.
Time frame: Through Day 21
Days Alive
Number of days through Day 21 during which the participant was alive for 24 continuous hours during a calendar day. Days following PICU discharge through Day 21 are considered days alive unless the participant is deceased. Participants withdrawn due to limitation of care orders or brain death evaluation are considered deceased on the day death is pronounced.
Time frame: Through Day 21
Number of Participants With Normal Pediatric Cerebral Performance Category (PCPC) at PICU Discharge or Day 21
The Pediatric Cerebral Performance Category (PCPC) is a 6-point scale of cerebral functional status: 1 = normal, 2 = mild disability, 3 = moderate disability, 4 = severe disability, 5 = coma or vegetative state, and 6 = death. This outcome reports the number of participants with normal cerebral performance, defined as a PCPC score of 1, at the earlier of PICU discharge or Day 21
Time frame: Earlier of PICU discharge or Day 21
Number of Participants With Normal Pediatric Overall Performance Category (POPC) at PICU Discharge or Day 21
The Pediatric Overall Performance Category (POPC) is a 6-point scale of overall functional status: 1 = normal/good overall performance, 2 = mild disability, 3 = moderate disability, 4 = severe disability, 5 = coma or vegetative state, and 6 = death. This outcome reports the number of participants with normal overall performance, defined as a POPC score of 1, at the earlier of PICU discharge or Day 21.
Time frame: Earlier of PICU discharge or Day 21
Functional Status Scale (FSS) Category at Patient Discharge
The Functional Status Scale (FSS) assesses six domains of pediatric function: mental status, sensory functioning, communication, motor functioning, feeding, and respiratory status. Each domain is scored from 1 (normal) to 5 (very severe dysfunction), producing a total score from 6 to 30, with lower scores indicating better functional status. Participants were categorized according to their FSS score at discharge.
Time frame: At patient discharge
This was a pragmatic, stepped-wedge cluster randomized trial conducted in 10 pediatric intensive care units (PICUs) in the United States. All sites began in the baseline/control period and transitioned to implementation of the PICU Up! intervention according to a randomly determined stepped-wedge sequence, with two PICUs transitioning at each of five sequential steps. Participant data were collected during the usual care and post-implementation periods for patients meeting eligibility criteria.
| Milestone | Step 1: 10m Usual Care, 3m Implementation, 17m Post-intervention (Hospitals A & B) | Step 2: 12m Usual Care, 3m Implementation, 15m Post-intervention (Hospitals C & D) | Step 3: 14m Usual Care, 3m Implementation, 13m Post-intervention (Hospitals E & F) | Step 4: 16m Usual Care, 3m Implementation, 11m Post-intervention (Hospitals G & H) | Step 5: 18m Usual Care, 3m Implementation, 9m Post-intervention (Hospitals I & J) |
|---|---|---|---|---|---|
| Started | 377 | 351 | 275 | 363 | 104 |
| Completed | 377 | 351 | 275 | 363 | 104 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
Number of days through Day 21 during which the participant is alive and free of invasive mechanical ventilation. A ventilator-free day is a calendar day during which the participant is alive and the endotracheal tube is absent for 24 continuous hours. For participants with a tracheostomy, unassisted breathing is considered ventilator-free; assisted ventilation is not.
| Days | Baseline/Pre-implementation | Intervention/Post-implementation |
|---|---|---|
| Days Alive and Ventilator-Free (AVF) | 10.5 ± 5.5 | 10.7 ± 5.6 |
Number of days through Day 21 during which the participant is alive, without delirium, and coma-free for 24 continuous hours during a calendar day.
| Days | Baseline/Pre-implementation | Intervention/Post-implementation |
|---|---|---|
| Days Alive and Delirium- and Coma-Free (ADCF) | 10.9 ± 6.1 | 10.7 ± 6.2 |
Number of days through Day 21 during which the participant was alive and coma-free for 24 continuous hours during a calendar day. Coma-free days are defined as days when all documented sedation scores are above the following thresholds: State Behavioral Scale (SBS) ≥ -1, Richmond Agitation-Sedation Scale (RASS) ≥ -3, or COMFORT-B ≥ 10, as applicable. Days following PICU discharge through Day 21 are considered alive and coma-free unless the participant is deceased.
| Days | Baseline/Pre-implementation | Intervention/Post-implementation |
|---|---|---|
| Days Alive and Coma-Free (ACF) | 16.4 ± 5.2 | 16.5 ± 5.2 |
Number of days through Day 21 during which the participant was alive for 24 continuous hours during a calendar day. Days following PICU discharge through Day 21 are considered days alive unless the participant is deceased. Participants withdrawn due to limitation of care orders or brain death evaluation are considered deceased on the day death is pronounced.
| Days | Baseline/Pre-implementation | Intervention/Post-implementation |
|---|---|---|
| Days Alive | 20.7 ± 1.8 | 20.6 ± 2.3 |
The Pediatric Cerebral Performance Category (PCPC) is a 6-point scale of cerebral functional status: 1 = normal, 2 = mild disability, 3 = moderate disability, 4 = severe disability, 5 = coma or vegetative state, and 6 = death. This outcome reports the number of participants with normal cerebral performance, defined as a PCPC score of 1, at the earlier of PICU discharge or Day 21
| Participants | Baseline/Pre-implementation | Intervention/Post-implementation |
|---|---|---|
| Number of Participants With Normal Pediatric Cerebral Performance Category (PCPC) at PICU Discharge or Day 21 | 371 | 383 |
The Pediatric Overall Performance Category (POPC) is a 6-point scale of overall functional status: 1 = normal/good overall performance, 2 = mild disability, 3 = moderate disability, 4 = severe disability, 5 = coma or vegetative state, and 6 = death. This outcome reports the number of participants with normal overall performance, defined as a POPC score of 1, at the earlier of PICU discharge or Day 21.
| Participants | Baseline/Pre-implementation | Intervention/Post-implementation |
|---|---|---|
| Number of Participants With Normal Pediatric Overall Performance Category (POPC) at PICU Discharge or Day 21 | 302 | 313 |
The Functional Status Scale (FSS) assesses six domains of pediatric function: mental status, sensory functioning, communication, motor functioning, feeding, and respiratory status. Each domain is scored from 1 (normal) to 5 (very severe dysfunction), producing a total score from 6 to 30, with lower scores indicating better functional status. Participants were categorized according to their FSS score at discharge.
| Participants | Baseline/Pre-implementation | Intervention/Post-implementation |
|---|---|---|
| Normal/Good (Score 6-7) | 160 | 147 |
| Mild/Moderate Dysfunction (Score 8-15) | 433 | 433 |
| Severe/Very Severe Dysfunction (Score 16-30) | 141 | 112 |
Collected over From PICU admission through PICU discharge or Day 21, whichever occurred first.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Usual PICU Care | 18/752 (2.4%) | — | — |
| PICU Up! Post-Implementation | 23/718 (3.2%) | 2/718 (0.3%) | 39/718 (5.4%) |
| Event | Usual PICU Care | PICU Up! Post-Implementation |
|---|---|---|
| Accidental endotracheal tube dislodgement with hypoxic cardiac arrestInjury, poisoning and procedural complications | — | 1/718 |
| Accidental endotracheal tube dislodgementInjury, poisoning and procedural complications | — | 1/718 |
| Event | Usual PICU Care | PICU Up! Post-Implementation |
|---|---|---|
| ReintubationInjury, poisoning and procedural complications | — | 39/718 |
| Age, Customized(Participants) | Baseline/Pre-implementation | Intervention/Post-implementation | Total |
|---|---|---|---|
| 0-2 years | 426 | 373 | 799 |
| 3-6 years | 100 | 106 | 206 |
| 7-12 years | 94 | 105 | 199 |
| 13-18 years | 111 | 115 | 226 |
| >18 years | 21 | 19 | 40 |
| Sex: Female, Male(Participants) | Baseline/Pre-implementation | Intervention/Post-implementation | Total |
|---|---|---|---|
| Female | 327 | 301 | 628 |
| Male | 425 | 417 | 842 |
| Race (NIH/OMB)(Participants) | Baseline/Pre-implementation | Intervention/Post-implementation | Total |
|---|---|---|---|
| American Indian or Alaska Native | 6 | 5 | 11 |
| Asian | 29 | 22 | 51 |
| Native Hawaiian or Other Pacific Islander | 0 | 3 | 3 |
| Black or African American | 134 | 141 | 275 |
| White | 477 | 462 | 939 |
| More than one race | 14 | 13 | 27 |
| Unknown or Not Reported | 92 | 72 | 164 |
| Baseline Pediatric Cerebral Performance Category, Normal(Participants) | Baseline/Pre-implementation | Intervention/Post-implementation | Total |
|---|---|---|---|
| Count of participants | 505 | 523 | 1028 |
| Baseline Pediatric Overall Performance Category, Normal(Participants) | Baseline/Pre-implementation | Intervention/Post-implementation | Total |
|---|---|---|---|
| Count of participants | 476 | 485 | 961 |
| Baseline Functional Status Scale, Normal(Participants) | Baseline/Pre-implementation | Intervention/Post-implementation | Total |
|---|---|---|---|
| Count of participants | 512 | 496 | 1008 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — Data generated in this grant will be presented in a timely fashion at national and international meetings and in publications. All final peer-reviewed manuscripts that arise from this proposal will be submitted to the digital archive PubMed Central. The investigators plan to share data from this research with other researchers who have interests in improving outcomes in critically ill children through early and progressive mobility interventions. Written proposals for data sharing requests will be accepted and reviewed by an independent review committee to ensure the proposal is scientifically and methodologically sound and not duplicative with other analyses. If approved, data sharing would occur after establishing a data use agreement with institutional signing authorities of each institution. Medical record and outcomes data will then be made available in the form of deidentified datasets with no identifiers in keeping with NIH Data Sharing Policy and Implementation Guidance.
Ran from Aug 2022 to primary completion in Aug 2025, 36 months.
Results were first posted in Oct 2026, 1 year 1 month after primary completion. A results delay was requested in Aug 2026.
Of 399 non-industry interventional studies with no phase under Critical Illness, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's 36 months is above that.
Counting every sponsor, half of 403 studies reached it within 21 months; a quarter within 12 and three quarters within 40.
Critical Illness covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
Completion moved once since we started tracking on Sep 25, 2026: Sep 2026 → Aug 2025, on Oct 1, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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