ChildPICU Up!NCT04989790
Clinical Effectiveness of the "PICU Up!" Multifaceted Early Mobility Intervention for Critically Ill Children
A study testing PICU Up! in people with Child and Intensive Care Unit Acquired Weakness, run by Johns Hopkins University at 11 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Child, Intensive Care Unit Acquired Weakness, Critical Illness
- What is being tested?
- PICU Up!
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,470 participants
- Where
- 11 sitesUnited States
- Study dates
- 8 Aug 2022to 11 Aug 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Invasive mechanical ventilation via oral or nasal endotracheal tube ≥ 48 hours at 7 a.m. on PICU Day 3
Who cannot join
- Active or anticipated withdrawal of life support within 48 hours
- Open chest or open abdomen
- Current use of Extracorporeal Membrane Oxygenation (ECMO)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
UNC Children's: University of North Carolina
Chapel Hill, North Carolina, 27514
Janet Weis Children's Hospital: Geisinger Commonwealth School of Medicine
Danville, Pennsylvania, 17822
Texas Children's Hospital: Baylor College of Medicine
Houston, Texas, 77030
Children's Hospital at Dartmouth: Geisel School of Medicine
Lebanon, New Hampshire, 03756
Norton Children's Hospital: University of Louisville
Louisville, Kentucky, 40202
Valley Children's Hospital
Madera, California, 93636
Children's Hospital of Wisconsin: Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Hennepin Healthcare: University of Minnesota
Minneapolis, Minnesota, 55415
West Virginia University Medicine Children's: West Virginia University
Morgantown, West Virginia, 26506
Nemours Children's Hospital of the Nemours Foundation
Orlando, Florida, 32827
About this study
Official title: Clinical Effectiveness of the "PICU Up!" Multifaceted Early Mobility Intervention for Critically Ill Children: A Pragmatic, Stepped-wedge Trial
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.
- Conditions
- Child, Intensive Care Unit Acquired Weakness, Critical Illness, Hospital Acquired Pressure Ulcer
- Being tested
- PICU Up!
- Keywords
- physical rehabilitation, post-intensive care syndrome, pediatric intensive care unit, sleep, sedation, delirium, physical therapy, occupational therapy
- Medical subject headings
- Critical Illness, postintensive care syndrome, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICU Up!Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Baseline/Pre-implementation | No intervention | Usual PICU care |
| Intervention/Post-implementation | Active comparator | PICU Up! is a multifaceted, inter-professional pathway that is integrated into routine PICU practice to safely optimize early and progressive patient mobility. Receives: Other: PICU Up! |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through Day 21
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: At patient discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start8 Aug 2022
- Primary completion11 Aug 2025
- Study completion11 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for ChildStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Stepped-wedge cluster Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Sapna Kudchadkar, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989790
- Sponsor's protocol ID
- IRB00297110
- Other IDs
- R01HD103811
- Acronym
- PICU Up!
- Status last verified
- Sep 2026
- First submitted
- 26 Jul 2021
- Last updated
- 1 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Wieczorek B, Ascenzi J, Kim Y, Lenker H, Potter C, Shata NJ, Mitchell L, Haut C, Berkowitz I, Pidcock F, Hoch J, Malamed C, Kravitz T, Kudchadkar SR. PICU Up!: Impact of a Quality Improvement Intervention to Promote Early Mobilization in Critically Ill Children. Pediatr Crit Care Med. 2016 Dec;17(12):e559-e566. doi: 10.1097/PCC.0000000000000983.
PubMed 27759596Patel RV, Redivo J, Nelliot A, Eakin MN, Wieczorek B, Quinn J, Gurses AP, Balas MC, Needham DM, Kudchadkar SR. Early Mobilization in a PICU: A Qualitative Sustainability Analysis of PICU Up! Pediatr Crit Care Med. 2021 Apr 1;22(4):e233-e242. doi: 10.1097/PCC.0000000000002619.
PubMed 33315754Kudchadkar SR, Nelliot A, Awojoodu R, Vaidya D, Traube C, Walker T, Needham DM; Prevalence of Acute Rehabilitation for Kids in the PICU (PARK-PICU) Investigators and the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Physical Rehabilitation in Critically Ill Children: A Multicenter Point Prevalence Study in the United States. Crit Care Med. 2020 May;48(5):634-644. doi: 10.1097/CCM.0000000000004291.
PubMed 32168030Choong K, Canci F, Clark H, Hopkins RO, Kudchadkar SR, Lati J, Morrow B, Neu C, Wieczorek B, Zebuhr C. Practice Recommendations for Early Mobilization in Critically Ill Children. J Pediatr Intensive Care. 2018 Mar;7(1):14-26. doi: 10.1055/s-0037-1601424. Epub 2017 Apr 10.
PubMed 31073462Traube C, Silver G, Reeder RW, Doyle H, Hegel E, Wolfe HA, Schneller C, Chung MG, Dervan LA, DiGennaro JL, Buttram SD, Kudchadkar SR, Madden K, Hartman ME, deAlmeida ML, Walson K, Ista E, Baarslag MA, Salonia R, Beca J, Long D, Kawai Y, Cheifetz IM, Gelvez J, Truemper EJ, Smith RL, Peters ME, O'Meara AM, Murphy S, Bokhary A, Greenwald BM, Bell MJ. Delirium in Critically Ill Children: An International Point Prevalence Study. Crit Care Med. 2017 Apr;45(4):584-590. doi: 10.1097/CCM.0000000000002250.
PubMed 28079605Walker TC, Kudchadkar SR. Early mobilization in the pediatric intensive care unit. Transl Pediatr. 2018 Oct;7(4):308-313. doi: 10.21037/tp.2018.09.02.
PubMed 30460183Hopkins RO, Choong K, Zebuhr CA, Kudchadkar SR. Transforming PICU Culture to Facilitate Early Rehabilitation. J Pediatr Intensive Care. 2015 Dec;4(4):204-211. doi: 10.1055/s-0035-1563547.
PubMed 27134761Ista E, Scholefield BR, Manning JC, Harth I, Gawronski O, Bartkowska-Sniatkowska A, Ramelet AS, Kudchadkar SR; EU PARK-PICU Collaborators. Mobilization practices in critically ill children: a European point prevalence study (EU PARK-PICU). Crit Care. 2020 Jun 24;24(1):368. doi: 10.1186/s13054-020-02988-2.
PubMed 32576273Wieczorek B, Burke C, Al-Harbi A, Kudchadkar SR. Early mobilization in the pediatric intensive care unit: a systematic review. J Pediatr Intensive Care. 2015;2015(4):129-170. doi: 10.1055/s-0035-1563386. Epub 2015 Sep 3.
PubMed 26380147Flaigle MC, Ascenzi J, Kudchadkar SR. Identifying Barriers to Delirium Screening and Prevention in the Pediatric ICU: Evaluation of PICU Staff Knowledge. J Pediatr Nurs. 2016 Jan-Feb;31(1):81-4. doi: 10.1016/j.pedn.2015.07.009. Epub 2015 Sep 9.
PubMed 26362671Kudchadkar SR, Aljohani O, Johns J, Leroux A, Alsafi E, Jastaniah E, Gottschalk A, Shata NJ, Al-Harbi A, Gergen D, Nadkarni A, Crainiceanu C. Day-Night Activity in Hospitalized Children after Major Surgery: An Analysis of 2271 Hospital Days. J Pediatr. 2019 Jun;209:190-197.e1. doi: 10.1016/j.jpeds.2019.01.054. Epub 2019 Mar 15.
PubMed 30885646Miura S, Wieczorek B, Lenker H, Kudchadkar SR. Normal Baseline Function Is Associated With Delayed Rehabilitation in Critically Ill Children. J Intensive Care Med. 2020 Apr;35(4):405-410. doi: 10.1177/0885066618754507. Epub 2018 Jan 22.
PubMed 29357778Choong K, Zorko DJ, Awojoodu R, Ducharme-Crevier L, Fontela PS, Lee LA, Guerguerian AM, Garcia Guerra G, Krmpotic K, McKelvie B, Menon K, Murthy S, Sehgal A, Weiss MJ, Kudchadkar SR. Prevalence of Acute Rehabilitation for Kids in the PICU: A Canadian Multicenter Point Prevalence Study. Pediatr Crit Care Med. 2021 Feb 1;22(2):181-193. doi: 10.1097/PCC.0000000000002601.
PubMed 33116069Kudchadkar SR, Yaster M, Punjabi NM. Sedation, sleep promotion, and delirium screening practices in the care of mechanically ventilated children: a wake-up call for the pediatric critical care community*. Crit Care Med. 2014 Jul;42(7):1592-600. doi: 10.1097/CCM.0000000000000326.
PubMed 24717461Ghafoor S, Fan K, Williams S, Brown A, Bowman S, Pettit KL, Gorantla S, Quillivan R, Schwartzberg S, Curry A, Parkhurst L, James M, Smith J, Canavera K, Elliott A, Frett M, Trone D, Butrum-Sullivan J, Barger C, Lorino M, Mazur J, Dodson M, Melancon M, Hall LA, Rains J, Avent Y, Burlison J, Wang F, Pan H, Lenk MA, Morrison RR, Kudchadkar SR. Beginning Restorative Activities Very Early: Implementation of an Early Mobility Initiative in a Pediatric Onco-Critical Care Unit. Front Oncol. 2021 Mar 8;11:645716. doi: 10.3389/fonc.2021.645716. eCollection 2021.
PubMed 33763377