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NCT03860168 · ClinicalTrials.gov registry record · NA
PICU Up!: A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children
A NA study of Critical Illness, sponsored by Johns Hopkins University.
- Active
- Registry status
- NA
- Development phase
- 2,500
- Enrollment target
- 1
- Study location
NCT03860168: Active NA study of Critical Illness, sponsored by Johns Hopkins University.
NCT03860168 is a NA study of Critical Illness that is active but no longer recruiting, run by Johns Hopkins University. The registered enrollment target is 2,500 participants, below the 3,111-participant average among 91 other Critical Illness trials with a reported enrollment target (20% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03860168, a NA study of Critical Illness, is active but no longer recruiting, sponsored by Johns Hopkins University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 2,500 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Defined as the number of days of mechanical ventilation through an endotracheal tube during the first 28 days of PICU admission.
Conditions Studied
Interventions
- OTHER PICU Up!
Study Locations (1)
Maryland
- Johns Hopkins Hospital - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,500 participants |
| Start Date | 2019-04-01 |
| Est. Completion | 2026-05-31 |
| Phase | NA |
What the registry record for NCT03860168 still lists
NCT03860168 is an interventional study that assigns participants to a tested intervention. Its 2,500 participants enrollment target places it among the larger protocols in the corpus, below the 3,111-participant average among 91 other Critical Illness trials with a reported enrollment target (20% lower).
The record links to 1 condition, with Critical Illness appearing as the primary indexed condition, and to 1 intervention - of which PICU Up! is the first listed.
NCT03860168 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03860168 about?
NCT03860168 is a clinical study titled "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 cli...
What is the current status of trial NCT03860168?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 2,500 participants. The study started on 2019-04-01. Estimated completion is 2026-05-31.
What conditions does trial NCT03860168 study?
This clinical trial studies the following conditions: Critical Illness.
What interventions are being tested in trial NCT03860168?
The interventions under investigation include: PICU Up! (OTHER).
Who is sponsoring clinical trial NCT03860168?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03860168 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03860168's enrollment target sits among peer trials
2,500 10th of 91 higher than 82 of 91 other Critical Illness trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Critical Illness trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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