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Early Mobility Intervention for Critically Ill Children (PICU Up! Trial)

N/A
Waitlist Available
Led By Sapna R Kudchadkar, MD, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
No Placebo-Only Group

Summary

This trial will test the feasibility of a new program to help critically ill children recover more quickly by increasing their mobility while they are in the PICU.

Who is the study for?
This trial is for critically ill children in PICUs that haven't started a mobility program. It's open to all patients admitted, but only those staying 3 days or more are included in the data analysis. Children with an active do-not-resuscitate (DNR) order are excluded.
What is being tested?
'PICU Up!' is being tested; it's a program combining sleep promotion, delirium prevention, and sedation optimization to encourage early mobilization of young patients in the PICU to improve their recovery and reduce ICU-acquired issues.
What are the potential side effects?
Since 'PICU Up!' involves non-pharmaceutical interventions like movement and therapy activities rather than drugs, side effects aren't typical as with medication but may include fatigue or discomfort during physical activity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Duration of mechanical ventilation (days)
Secondary study objectives
Number of patients discharged from the hospital to a place other than home

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: PICU Up! pre- and post-implementationExperimental Treatment1 Intervention
Each unit will begin in the baseline, usual care phase and then be randomized to implement the PICU Up! program during a set time period, followed by the post-implementation phase.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,326 Previous Clinical Trials
14,872,229 Total Patients Enrolled
Donaghue Medical Research FoundationOTHER
23 Previous Clinical Trials
575,967 Total Patients Enrolled
Sapna R Kudchadkar, MD, PhDPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
72 Total Patients Enrolled

Media Library

PICU Up! Clinical Trial Eligibility Overview. Trial Name: NCT03860168 — N/A
Difficult Weaning Research Study Groups: PICU Up! pre- and post-implementation
Difficult Weaning Clinical Trial 2023: PICU Up! Highlights & Side Effects. Trial Name: NCT03860168 — N/A
PICU Up! 2023 Treatment Timeline for Medical Study. Trial Name: NCT03860168 — N/A
~380 spots leftby Nov 2025