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NCT Number: NCT03860168

PICU Up!: A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children

Recent decreases in Pediatric Intensive Care Unit (PICU) mortality rates have been offset by increased morbidity and length of stay for vulnerable young patients. Heavy sedation, bedrest, and delirium contribute to a PICU culture of immobility. While studies in adult ICU patients demonstrate the clinical benefits of early mobilization, fewer than 25% of critically ill children mobilize early in the children's PICU stay. The investigators have demonstrated the safety and feasibility of the 'PICU Up!' Mobility Program, which integrates sleep promotion, delirium prevention, sedation optimization as a bundle to increase mobilization. However, the generalizability and broader impact on patient- and family-centered outcomes is unknown. Therefore, there is an urgent need for trials that blend both clinical effectiveness and implementation research to create a PICU culture of mobility and improve the value of PICU care. The overall objective of the proposed research is to determine the impact of a transdisciplinary and multifaceted early mobility program on clinical outcomes and ICU-acquired morbidities in critically ill children. Additionally, the investigators will identify barriers and facilitators to high-performance bundle adoption.

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Key information

Conditions

Critical Illness Confusion Delirium Disease Attributes Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

0 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Participating Units:

  • Participating PICUs must be a separate physical space dedicated to the care of critically ill infants and children, with the ability to provide mechanical ventilation.
  • Not implemented a PICU mobility protocol and would commit to not implementing a mobility protocol until the randomized time of unit implementation.

Inclusion criteria

for Patients:

All patients admitted to the PICUs regardless of length of stay will receive the unit-based PICU Up! intervention, which includes criteria for no mobilization based on specific clinical factors (i.e. open chest, surgeon request).10 For inclusion in data analysis, patients will be eligible if

  • Admitted to the participating PICU ≥ 3 days.

Exclusion criteria

for Patients:

  • Patients with an active do-not-resuscitate (DNR) order will be excluded.

Treatment and study plan

PICU Up!

Other

The PICU Up! intervention is a multifaceted mobility program incorporating the ABCDEF bundle components into routine PICU care through multidisciplinary staff education and a structured pathway to determine a patient's daily mobility goal. PICU Up! was developed by a collaborative multidisciplinary team approach, and the central components include the consultation and involvement of physical therapy/occupational therapy (PT/OT) by PICU Day 3, sleep hygiene promotion and routine delirium screening for all PICU patients utilizing a validated tool.

Primary outcomes

  1. Duration of mechanical ventilation (days)

    Time frame: 28 days

    Defined as the number of days of mechanical ventilation through an endotracheal tube during the first 28 days of PICU admission.

Secondary outcomes

  1. PICU length of stay (days)

    Time frame: 28 days

  2. Hospital length of stay (days)

    Time frame: 28 days

  3. Proportion of patients receiving out-of-bed mobility before PICU Day 28

    Time frame: 28 days

  4. Number of patients discharged directly to home from the PICU

    Time frame: 28 days

  5. Number of patients discharged from the hospital to a place other than home

    Time frame: 28 days

    Number of patients discharged from the hospital to a place other than home (rehabilitation facility) if previous residence was home

  6. Incidence of venous thromboembolism

    Time frame: 28 days

  7. Incidence of pressure injury

    Time frame: 28 days

  8. Cumulative exposure to opioids (mg/kg) through PICU Day 28

    Time frame: 28 days

  9. Cumulative exposure to benzodiazepines (mg/kg) through PICU Day 28

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Donaghue Medical Research Foundation

Registry information

Official study title

PICU Up!:A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children

Acronym: PICU Up!

Important dates

Study start
2019
Primary completion
2021
Study completion
2026
First posted
Mar 1, 2019
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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