Clinical trial NCT04967365: Post-Intensive Care Syndrome - Pediatrics (PICS-p): Longitudinal Cohort Study
Official title: Post-Intensive Care Syndrome - Pediatrics (PICS-p): Longitudinal Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Critical Illness
Post Intensive Care Unit Syndrome
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Seattle Children's Hospital
name: Boston Children's Hospital
First posted: 2021-07-19
Enrollment: 755
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patents surviving a pediatric intensive care unit hospitalization

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Health related quality of life (HRQOL) - Patient
timeFrame: Two years
measure: Health related quality of life (HRQOL) - Parent
timeFrame: Two years
Secondary outcomes:
measure: Fatigue - Patient
timeFrame: Two Years
measure: Fatigue - Parent
timeFrame: Two Years
measure: Sleep - Patient
timeFrame: Two Years
measure: Sleep - Parent
timeFrame: Two Years
measure: Cognitive Functioning - Patient
timeFrame: Two Years
measure: Cognitive Functioning - Parent
timeFrame: Two Years
measure: Pain - Patient
timeFrame: Two Years
measure: Post Traumatic Stress Disorder (PTSD)- Patient
timeFrame: Two Years
measure: Post Traumatic Stress Disorder (PTSD)- Parent
timeFrame: Two Years
measure: Strengths and Difficulties - Patient
timeFrame: Two Years
measure: Strengths and Difficulties - Sibling
timeFrame: Two Years
measure: Hope - Patient
timeFrame: Two Years
measure: Hope - Sibling
timeFrame: Two Years
measure: Growth and Development - Patient
timeFrame: Two Years
measure: Functional status - Patient
timeFrame: Two Years
measure: Family impact
timeFrame: Two years
measure: Growth - Parent
timeFrame: Two Years
measure: Depression - Parent
timeFrame: Two years
measure: HRQOL - Sibling
timeFrame: Two Years
measure: Caregiving - Sibling
timeFrame: Two Years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Children's Hospital
state: Alabama
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Los Angeles
country: United States
facility: Annopinder Bhalla MD
state: California
city: Palo Alto
country: United States
facility: Lucille Packard Children's Hospital Stanford
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Washington
country: United States
facility: Children's National Hospital
state: District of Columbia
city: Atlanta
country: United States
facility: Children's Hospital of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Ann & Robert H Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: Comer Children's Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Riley Children's Health at Indiana University
state: Indiana
city: Louisville
country: United States
facility: Norton Children's Hospital
state: Kentucky
city: Baltimore
country: United States
facility: Charlotte R Bloomberg Children's Center
state: Maryland
city: Detroit
country: United States
facility: CS Mott Children's Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Massonic Children's Hospital
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: St Louis Children's Hospital
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Chapel Hill
country: United States
facility: UNC Children's Hospital Chapel Hill
state: North Carolina
city: Winston-Salem
country: United States
facility: Brenner Children's Hospital
state: North Carolina
city: Cleveland
country: United States
facility: Rainbow Babies and Children's Hospital
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Portland
country: United States
facility: Doernbecher Children's Hospital
state: Oregon
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Memphis
country: United States
facility: LeBonheur Children's Hospital
state: Tennessee
city: Austin
country: United States
facility: Dell Children's Medical Center of Central Texas
state: Texas
city: Dallas
country: United States
facility: Children's Medical Center Dallas
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
city: Richmond
country: United States
facility: Children's Hospital of Richmond
state: Virginia
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: University of Pennsylvania
name: Martha AQ Curley, RN, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seattle Children's Hospital
name: R. Scott Watson, MD
role: PRINCIPAL_INVESTIGATOR
References: