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

Critical Illness Clinical Trial

— PICS-p  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04967365
• Other study ID #: 843844
• Status: Recruiting
• Start date: July 27, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: September 2023
• Source: University of Pennsylvania
• Contact: Martha AQ Curley, RN, PhD
• Phone: 215-573-9449
• Email: curley[@]upenn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Post Intensive Care Unit Syndrome
• Syndrome

Locations

Country	Name	City	State
United States	Children's Hospital of Atlanta	Atlanta	Georgia
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Dell Children's Medical Center of Central Texas	Austin	Texas
United States	Charlotte R Bloomberg Children's Center	Baltimore	Maryland
United States	Alabama Children's Hospital	Birmingham	Alabama
United States	UNC Children's Hospital Chapel Hill	Chapel Hill	North Carolina
United States	Ann & Robert H Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Comer Children's Hospital	Chicago	Illinois
United States	Rainbow Babies and Children's Hospital	Cleveland	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Children's Medical Center Dallas	Dallas	Texas
United States	CS Mott Children's Hospital	Detroit	Michigan
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	Texas Children's Hospital	Houston	Texas
United States	Riley Children's Health at Indiana University	Indianapolis	Indiana
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Annopinder Bhalla MD	Los Angeles	California
United States	Norton Children's Hospital	Louisville	Kentucky
United States	LeBonheur Children's Hospital	Memphis	Tennessee
United States	Massonic Children's Hospital	Minneapolis	Minnesota
United States	Lucille Packard Children's Hospital Stanford	Palo Alto	California
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Doernbecher Children's Hospital	Portland	Oregon
United States	Children's Hospital of Richmond	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	St Louis Children's Hospital	Saint Louis	Missouri
United States	Primary Children's Hospital	Salt Lake City	Utah
United States	Seattle Children's Hospital	Seattle	Washington
United States	Children's National Hospital	Washington	District of Columbia
United States	Brenner Children's Hospital	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	Boston Children's Hospital, Seattle Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

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