Post-Intensive Care Syndrome - Pediatrics (PICS-p): Longitudinal Cohort Study (PICS-p)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Critical Illness; Post Intensive Care Unit Syndrome

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.

• Study Type: Observational
• Enrollment (Actual): 755

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Alabama Children's Hospital
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Hospital
  • California
    • Los Angeles, California, United States, 90027
      • Annopinder Bhalla MD
    • Palo Alto, California, United States, 94304
      • Lucille Packard Children's Hospital Stanford
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Children's National Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Children's Hospital of Atlanta
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H Lurie Children's Hospital of Chicago
    • Chicago, Illinois, United States, 60637
      • Comer Children's Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Children's Health at Indiana University
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Norton Children's Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Charlotte R Bloomberg Children's Center
  • Michigan
    • Detroit, Michigan, United States, 48201
      • CS Mott Children's Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • Massonic Children's Hospital
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • St Louis, Missouri, United States, 63110
      • St Louis Children's Hospital
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Children's Hospital Chapel Hill
    • Winston-Salem, North Carolina, United States, 27157
      • Brenner Children's Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Rainbow Babies and Children's Hospital
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital
  • Oregon
    • Portland, Oregon, United States, 97239
      • Doernbecher Children's Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • LeBonheur Children's Hospital
  • Texas
    • Austin, Texas, United States, 78723
      • Dell Children's Medical Center of Central Texas
    • Dallas, Texas, United States, 75390
      • Children's Medical Center Dallas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • Primary Children's Hospital
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Children's Hospital of Richmond
  • Washington
    • Seattle, Washington, United States, 98101
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 16 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Pediatric patents surviving a pediatric intensive care unit hospitalization

Description

Case Inclusion criteria:

1. Current admission is the child's first PICU (including pediatric subspecialty ICU) admission
2. Patient age ≥4 weeks and ≥44 weeks corrected gestational age and <16 years (has not yet reached 16th birthday) on PICU admission
3. At least one parent/legal guardian (≥18 years of age or considered emancipated) living with the potential subject
4. 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).
5. Anticipated patient discharge to home (directly or indirectly after a stay in another facility)

Case Exclusion criteria:

1. Patient history of neonatal intensive care unit hospitalization
2. Life expectancy not anticipated to be more than one year (e.g., active do not resuscitate [DNR] plan or actively managed by the palliative care team for end-of-life symptom management)
3. Patient in foster care or ward of the state

Control subjects: As above but will be PICU patients who received an overnight PICU stay (<36 hours covering one midnight to 7am time period) that did not include intensive care therapies. Post-operative children who were intubated/extubated in the operating room/PACU (or intubated in the operating room and extubated in the PICU on arrival and prior to parent presence at the bedside) can be enrolled as control subjects. Control subjects will be frequency matched to cases on age group, sex, and medical complexity, that is, complex chronic disease (C-CD), noncomplex chronic disease (NC-CD), and without CD on a 2:1 case:control ratio.

Family Subjects: At least one eligible parent/legal guardian must be willing to participate. In addition, up to two cognitively capable siblings (PCPC of 1 or 2) aged 8 to <16 years, who live with the patient, and who have not been ICU hospitalized will be invited to participate. If more than two siblings are eligible, the two siblings with the next birthday (regardless of birth year) will be invited to participate.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Case patients; 500 patients who experience greater than or equal to 3 nights in a pediatric ICU with intensive care instrumentation.
Control patients; 250 patients who experience an overnight stay in a pediatric ICU without intensive care instrumentation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health related quality of life (HRQOL) - Patient	PedsQL™ 4.0 Generic Core or Infant Scales (self report)	Two years
Health related quality of life (HRQOL) - Parent	PedsQL™ 4.0 Generic Core or Infant Scales (parent report)	Two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue - Patient	PedsQL™ Multidimensional Fatigue Scale v3.0 (self report)	Two Years
Fatigue - Parent	PedsQL™ Multidimensional Fatigue Scale v3.0 (parent report)	Two Years
Sleep - Patient	PROMIS Pediatric Sleep Disturbance - Short Form 4a and Pediatric Sleep-Related Impairment - Short Form 4a (self report)	Two Years
Sleep - Parent	PROMIS Sleep Disturbance - Short Form 4a and Sleep-Related Impairment - Short Form 4a (parent report)	Two Years
Cognitive Functioning - Patient	PedsQL™ Cognitive Functioning Scale and Pediatric Cerebral Performance Category (PCPC)	Two Years
Cognitive Functioning - Parent	PedsQL™ Cognitive Functioning Scale (parent report) and Pediatric Cerebral Performance Category (PCPC) (parent report)	Two Years
Pain - Patient	PedsQL™ Pediatric Pain Questionnaire and PROMIS Pediatric Pain Interference - Short Form 8a (self report)	Two Years
Post Traumatic Stress Disorder (PTSD)- Patient	Child PTSD Symptom Scale for DSM-5 (CPSS-V) (self report)	Two Years
Post Traumatic Stress Disorder (PTSD)- Parent	Young Child PTSD Screen - Revised PICU (YCPS R - PICU) (parent report); PTSD Checklist for DSM-5 (PCL-5) (parent report)	Two Years
Strengths and Difficulties - Patient	Strengths and Difficulties Questionnaire (SDQ)	Two Years
Strengths and Difficulties - Sibling	Strengths and Difficulties Questionnaire (SDQ)	Two Years
Hope - Patient	Children's Hope Scale (CHS)	Two Years
Hope - Sibling	Children's Hope Scale (CHS)	Two Years
Growth and Development - Patient	Survey of Well-being of Young Children (SWYC) - Milestones only (parent report)	Two Years
Functional status - Patient	Functional Status Scale (FSS) and Pediatric Overall Performance Category (POPC) (parent report)	Two Years
Family impact	PedsQL™ Family Impact Module v2.0 (parent report)	Two years
Growth - Parent	Post-traumatic Growth Inventory - Short Form (PTGI-SF) (parent self report)	Two Years
Depression - Parent	Patient Health Questionnaire-4 (PHQ-4) (parent self report)	Two years
HRQOL - Sibling	PedsQL Version 4.0 Generic Core Scales (sibling self report)	Two Years
Caregiving - Sibling	Multidimensional Assessment of Caring Activities (MACA-YC18) (sibling self report)	Two Years

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Boston Children's Hospital; Seattle Children's Hospital
• Investigators: Principal Investigator: R. Scott Watson, MD, Seattle Children's Hospital; Principal Investigator: Martha AQ Curley, RN, PhD, University of Pennsylvania

Publications and helpful links

General Publications

• Curley MAQ, Watson RS, Killien EY, Kalvas LB, Perry-Eaddy MA, Cassidy AM, Miller EB, Talukder M, Manning JC, Pinto NP, Rennick JE, Colville G, Asaro LA, Wypij D. Design and rationale of the Post-Intensive Care Syndrome - paediatrics (PICS-p) Longitudinal Cohort Study. BMJ Open. 2024 Feb 24;14(2):e084445. doi: 10.1136/bmjopen-2024-084445.

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: June 28, 2021
• First Submitted That Met QC Criteria: July 8, 2021
• First Posted (Actual): July 19, 2021

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Critical Illness
• Other Study ID Numbers: 843844

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No