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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 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.

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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.

Conditions Studied

Critical Illness

Interventions

  • OTHER PICU Up!

Study Locations (1)

Maryland

  • Johns Hopkins Hospital - Baltimore

Trial Details

FieldValue
Enrollment Target 2,500 participants
Start Date 2019-04-01
Est. Completion 2026-05-31
Phase NA

Sponsor

Johns Hopkins University

1,448 total trials

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What the Registry Record Tells You About NCT03860168

The ClinicalTrials.gov registry entry for NCT03860168 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 2,500 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,111-participant average among 91 other Critical Illness trials with a reported enrollment target (20% lower). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.