Post-Intensive Care Syndrome - Pediatrics (PICS-p): Longitudinal Cohort Study
- Conditions
- Post Intensive Care Unit SyndromeCritical Illness
- Registration Number
- NCT04967365
- Lead Sponsor
- University of Pennsylvania
- Brief Summary
Pediatric Intensive Care Unit (PICU) survival has increased substantially over the past three decades. Currently, an understanding of PICU morbidity and recovery among PICU survivors and their families is limited. Post-intensive care syndrome (PICS) consists of new or worsening impairments in physical, cognitive, or mental health status that arise and may persist after critical illness. The characteristics of PICS in children (PICS-p) are unknown. The objective of this study is to learn about pediatric recovery from critical illness to guide future intervention research to optimize child and family health.
- Detailed Description
PICS-p is a prospective longitudinal cohort study of pediatric patients experiencing 3 or more days of intensive care therapies at one of approximately 30 U.S. PICUs to evaluate child and family outcomes over two years post-PICU discharge. We will compare outcomes of these PICU patients with a control group of patients who received an overnight PICU stay but did not receive intensive care therapies, as well as with published quality of life data from the general and chronically ill populations. Children and their families will be enrolled locally from each PICU, their baseline data will be collected by local research staff, and their post-discharge outcomes will be followed centrally from the University of Pennsylvania and the Seattle Children's Research Institute. Our specific aims are to determine the physical, cognitive, emotional, and social health outcomes and trajectory of recovery in a population of children post-critical illness; to determine the baseline health, presenting problem, and PICU factors associated with impaired physical, cognitive, emotional, and social outcomes among PICU survivors; and to determine the emotional and social health outcomes in parents and siblings of PICU survivors. Our primary goal is to explicate the impact of pediatric critical illness over a two-year period of time to guide future intervention research to optimize child and family outcomes. Our overall goal is to improve the health and well-being of PICU survivors and their families.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 755
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Health related quality of life (HRQOL) - Patient Two years PedsQL™ 4.0 Generic Core or Infant Scales (self report)
Health related quality of life (HRQOL) - Parent Two years PedsQL™ 4.0 Generic Core or Infant Scales (parent report)
- Secondary Outcome Measures
Name Time Method Fatigue - Parent Two Years PedsQL™ Multidimensional Fatigue Scale v3.0 (parent report)
Fatigue - Patient Two Years PedsQL™ Multidimensional Fatigue Scale v3.0 (self report)
Sleep - Patient Two Years PROMIS Pediatric Sleep Disturbance - Short Form 4a and Pediatric Sleep-Related Impairment - Short Form 4a (self report)
Cognitive Functioning - Parent Two Years PedsQL™ Cognitive Functioning Scale (parent report) and Pediatric Cerebral Performance Category (PCPC) (parent report)
Pain - Patient Two Years PedsQL™ Pediatric Pain Questionnaire and PROMIS Pediatric Pain Interference - Short Form 8a (self report)
Functional status - Patient Two Years Functional Status Scale (FSS) and Pediatric Overall Performance Category (POPC) (parent report)
Post Traumatic Stress Disorder (PTSD)- Parent Two Years Young Child PTSD Screen - Revised PICU (YCPS R - PICU) (parent report); PTSD Checklist for DSM-5 (PCL-5) (parent report)
Sleep - Parent Two Years PROMIS Sleep Disturbance - Short Form 4a and Sleep-Related Impairment - Short Form 4a (parent report)
Post Traumatic Stress Disorder (PTSD)- Patient Two Years Child PTSD Symptom Scale for DSM-5 (CPSS-V) (self report)
Cognitive Functioning - Patient Two Years PedsQL™ Cognitive Functioning Scale and Pediatric Cerebral Performance Category (PCPC)
Strengths and Difficulties - Patient Two Years Strengths and Difficulties Questionnaire (SDQ)
Hope - Patient Two Years Children's Hope Scale (CHS)
Family impact Two years PedsQL™ Family Impact Module v2.0 (parent report)
HRQOL - Sibling Two Years PedsQL Version 4.0 Generic Core Scales (sibling self report)
Strengths and Difficulties - Sibling Two Years Strengths and Difficulties Questionnaire (SDQ)
Hope - Sibling Two Years Children's Hope Scale (CHS)
Growth and Development - Patient Two Years Survey of Well-being of Young Children (SWYC) - Milestones only (parent report)
Growth - Parent Two Years Post-traumatic Growth Inventory - Short Form (PTGI-SF) (parent self report)
Depression - Parent Two years Patient Health Questionnaire-4 (PHQ-4) (parent self report)
Caregiving - Sibling Two Years Multidimensional Assessment of Caring Activities (MACA-YC18) (sibling self report)
Trial Locations
- Locations (30)
Lucille Packard Children's Hospital Stanford
🇺🇸Palo Alto, California, United States
Annopinder Bhalla MD
🇺🇸Los Angeles, California, United States
Children's National Hospital
🇺🇸Washington, District of Columbia, United States
Children's Hospital of Atlanta
🇺🇸Atlanta, Georgia, United States
Charlotte R Bloomberg Children's Center
🇺🇸Baltimore, Maryland, United States
St Louis Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
LeBonheur Children's Hospital
🇺🇸Memphis, Tennessee, United States
Children's Medical Center Dallas
🇺🇸Dallas, Texas, United States
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Alabama Children's Hospital
🇺🇸Birmingham, Alabama, United States
Doernbecher Children's Hospital
🇺🇸Portland, Oregon, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
Primary Children's Hospital
🇺🇸Salt Lake City, Utah, United States
Ann & Robert H Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Comer Children's Hospital
🇺🇸Chicago, Illinois, United States
CS Mott Children's Hospital
🇺🇸Detroit, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Riley Children's Health at Indiana University
🇺🇸Indianapolis, Indiana, United States
Massonic Children's Hospital
🇺🇸Minneapolis, Minnesota, United States
Rainbow Babies and Children's Hospital
🇺🇸Cleveland, Ohio, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Norton Children's Hospital
🇺🇸Louisville, Kentucky, United States
UNC Children's Hospital Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Brenner Children's Hospital
🇺🇸Winston-Salem, North Carolina, United States
Dell Children's Medical Center of Central Texas
🇺🇸Austin, Texas, United States
Children's Hospital of Richmond
🇺🇸Richmond, Virginia, United States