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

NCT04967365 | Active Not Recruiting

• 1 other identifier: 843844
• Study Type: observational
• Target: 755
• Locations: 1 country
• Sites: 30

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.

Conditions

Critical Illness; Post Intensive Care Unit Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (20)

• Fatigue - Patient

  Two Years

• Fatigue - Parent

  Two Years

• Sleep - Patient

  Two Years

• Sleep - Parent

  Two Years

• Cognitive Functioning - Patient

  Two Years

Study Arms (2)

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.

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Pediatric patents surviving a pediatric intensive care unit hospitalization

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seattle Children's Hospital: collaborator
• Boston Children's Hospital: collaborator
• University of Pennsylvania: lead

Study Sites (30)

Alabama Children's Hospital

Birmingham, Alabama, 35294, United States

Location

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Annopinder Bhalla MD

Los Angeles, California, 90027, United States

Location

Lucille Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

Location

Children's Hospital of Atlanta

Atlanta, Georgia, 30342, United States

Location

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Comer Children's Hospital

Chicago, Illinois, 60637, United States

Location

Riley Children's Health at Indiana University

Indianapolis, Indiana, 46202, United States

Location

Norton Children's Hospital

Louisville, Kentucky, 40202, United States

Location

Charlotte R Bloomberg Children's Center

Baltimore, Maryland, 21287, United States

Location

CS Mott Children's Hospital

Detroit, Michigan, 48201, United States

Location

Massonic Children's Hospital

Minneapolis, Minnesota, 55454, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

St Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

UNC Children's Hospital Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Brenner Children's Hospital

Winston-Salem, North Carolina, 27157, United States

Location

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Doernbecher Children's Hospital

Portland, Oregon, 97239, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

LeBonheur Children's Hospital

Memphis, Tennessee, 38103, United States

Location

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723, United States

Location

Children's Medical Center Dallas

Dallas, Texas, 75390, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Location

Children's Hospital of Richmond

Richmond, Virginia, 23298, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98101, United States

Location

Related Publications (1)

• 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.

  PMID: 38401903 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Martha AQ Curley, RN, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• R. Scott Watson, MD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 19, 2021
• Study Start: July 27, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (30)