Early mobility intervention for critically ill children in the PICU
Clinical Effectiveness of the "PICU Up!" Multifaceted Early Mobility Intervention for Critically Ill Children: A Pragmatic, Stepped-wedge Trial
This study is testing if getting critically ill children who are on ventilators moving early can help them recover better and avoid complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1440 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 11 sites (Madera, California and 10 other locations) |
| Trial ID | NCT04989790 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the 'PICU Up!' intervention, which focuses on early mobility for critically ill children who are mechanically ventilated. The study aims to address the high rates of PICU-acquired morbidities by implementing a multifaceted approach to rehabilitation within three days of mechanical ventilation initiation. By comparing outcomes in children receiving this intervention against standard care, the trial seeks to determine if early mobility can reduce muscle weakness and improve overall recovery. The study is conducted across multiple pediatric hospitals to gather diverse data on its effectiveness.
Who should consider this trial
Good fit: Ideal candidates are critically ill children requiring invasive mechanical ventilation for at least 48 hours.
Not a fit: Patients who are actively withdrawing life support or have open chest or abdomen conditions may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly improve recovery outcomes and quality of life for critically ill children in the PICU.
How similar studies have performed: Previous studies in adult populations have shown that early mobility can lead to significant improvements, suggesting potential success in pediatric applications, although this specific approach has not been extensively tested in children.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Invasive mechanical ventilation via oral or nasal endotracheal tube ≥ 48 hours at 7 a.m. on PICU Day 3 Exclusion Criteria: * Active or anticipated withdrawal of life support within 48 hours * Open chest or open abdomen * Current use of Extracorporeal Membrane Oxygenation (ECMO)
Where this trial is running
Madera, California and 10 other locations
- Valley Children's Hospital — Madera, California, United States (Recruiting)
- Nemours Children's Hospital of the Nemours Foundation — Orlando, Florida, United States (Recruiting)
- Norton Children's Hospital: University of Louisville — Louisville, Kentucky, United States (Recruiting)
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Active_not_recruiting)
- Hennepin Healthcare: University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
- Children's Hospital at Dartmouth: Geisel School of Medicine — Lebanon, New Hampshire, United States (Recruiting)
- UNC Children's: University of North Carolina — Chapel Hill, North Carolina, United States (Recruiting)
- Janet Weis Children's Hospital: Geisinger Commonwealth School of Medicine — Danville, Pennsylvania, United States (Recruiting)
- Texas Children's Hospital: Baylor College of Medicine — Houston, Texas, United States (Recruiting)
- West Virginia University Medicine Children's: West Virginia University — Morgantown, West Virginia, United States (Recruiting)
- Children's Hospital of Wisconsin: Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Sapna Kudchadkar, MD, PhD — Johns Hopkins University
- Study coordinator: Sapna R Kudchadkar, MD, PhD
- Email: sapna@jhmi.edu
- Phone: 410-955-6412
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.