Post-Intensive Care Syndrome - Pediatrics (PICS-p): Longitudinal Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pennsylvania
- Enrollment
- 755
- Locations
- 30
- Primary Endpoint
- Health related quality of life (HRQOL) - Patient
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 1 Month to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Case 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
- •At least one parent/legal guardian (≥18 years of age or considered emancipated) living with the potential subject
- •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).
- •Anticipated patient discharge to home (directly or indirectly after a stay in another facility)
Exclusion Criteria
- •Patient history of neonatal intensive care unit hospitalization
- •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)
- •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.
Arms & Interventions
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.
Outcomes
Primary Outcomes
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 Outcomes
- Fatigue - Parent(Two Years)
- Fatigue - Patient(Two Years)
- Sleep - Patient(Two Years)
- Cognitive Functioning - Parent(Two Years)
- Pain - Patient(Two Years)
- Functional status - Patient(Two Years)
- Post Traumatic Stress Disorder (PTSD)- Parent(Two Years)
- Sleep - Parent(Two Years)
- Post Traumatic Stress Disorder (PTSD)- Patient(Two Years)
- Cognitive Functioning - Patient(Two Years)
- Strengths and Difficulties - Patient(Two Years)
- Hope - Patient(Two Years)
- Family impact(Two years)
- HRQOL - Sibling(Two Years)
- Strengths and Difficulties - Sibling(Two Years)
- Hope - Sibling(Two Years)
- Growth and Development - Patient(Two Years)
- Growth - Parent(Two Years)
- Depression - Parent(Two years)
- Caregiving - Sibling(Two Years)