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

Overview

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.

Full Title of Study: “Post-Intensive Care Syndrome – Pediatrics (PICS-p): Longitudinal Cohort Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 30, 2025

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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Health related quality of life (HRQOL) – Patient
    • Time Frame: Two years
    • PedsQL™ 4.0 Generic Core or Infant Scales (self report)
  • Health related quality of life (HRQOL) – Parent
    • Time Frame: Two years
    • PedsQL™ 4.0 Generic Core or Infant Scales (parent report)

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 1 Month

Maximum Age: 16 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Pennsylvania
  • Collaborator
    • Seattle Children’s Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Martha AQ Curley, RN, PhD, Principal Investigator, University of Pennsylvania
    • R. Scott Watson, MD, Principal Investigator, Seattle Children’s Hospital
  • Overall Contact(s)
    • Martha AQ Curley, RN, PhD, 215-573-9449, curley@upenn.edu

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