Post-Intensive Care Syndrome for Critical Illness

(PICS-p Trial)

Not currently recruiting at 32 trial locations
AM
MA
Overseen ByMartha AQ Curley, RN, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Pennsylvania
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how children recover from severe illnesses after staying in a Pediatric Intensive Care Unit (PICU). Researchers seek to learn more about the physical, mental, and cognitive challenges these children face post-recovery, a condition known as post-intensive care syndrome in children (PICS-p). The study will guide future treatments to improve the health of both the children and their families. Children who have had their first PICU stay for at least three days, received intensive care treatments like mechanical ventilation, and are expected to go home after discharge qualify as good candidates for the trial. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance recovery outcomes for children and their families.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to better understand Post-Intensive Care Syndrome in children, a condition that can affect young patients after they've been in intensive care. Unlike current approaches that mostly focus on treating symptoms as they arise, this study seeks to track the long-term effects on children by observing them over time. By doing so, the researchers hope to identify specific patterns and factors that contribute to the syndrome, potentially leading to more effective, targeted interventions in the future. This longitudinal approach is unique because it could pave the way for preventive strategies rather than just reactive treatments.

Who Is on the Research Team?

MA

Martha AQ Curley, RN, PhD

Principal Investigator

University of Pennsylvania

RS

R. Scott Watson, MD

Principal Investigator

Seattle Children's Hospital

Are You a Good Fit for This Trial?

Inclusion Criteria

Current admission is the child's first PICU (including pediatric subspecialty ICU) admission
Patient age ≥4 weeks and ≥44 weeks corrected gestational age and <16 years (has not yet reached 16th birthday) on PICU admission
PICU LOS of 3 days (covering at least 3 nights from midnight to 7am) in which the patient received intensive care therapies for organ dysfunction (for example, invasive mechanical ventilation, vasopressors/inotropes, acute renal replacement therapy, or other extracorporeal therapies).
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Data Collection

Baseline data is collected by local research staff from each PICU

1-2 weeks

Post-Discharge Follow-up

Participants' outcomes are followed centrally from the University of Pennsylvania and the Seattle Children's Research Institute

Two years

Outcome Assessment

Assessment of physical, cognitive, emotional, and social health outcomes over two years

Two years

What Are the Treatments Tested in This Trial?

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

Seattle Children's Hospital

Collaborator

Trials
319
Recruited
5,232,000+

Boston Children's Hospital

Collaborator

Trials
801
Recruited
5,584,000+
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