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

Sponsor
University of Pennsylvania (Other)
Overall Status
Recruiting
CT.gov ID
NCT04967365
Collaborator
Seattle Children's Hospital (Other), Boston Children's Hospital (Other)
750
Enrollment
31
Locations
47.1
Anticipated Duration (Months)
24.2
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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
    Anticipated Enrollment :
    750 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Post-Intensive Care Syndrome - Pediatrics (PICS-p): Longitudinal Cohort Study
    Actual Study Start Date :
    Jul 27, 2021
    Anticipated Primary Completion Date :
    Jun 30, 2025
    Anticipated Study Completion Date :
    Jun 30, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Health related quality of life (HRQOL) - Patient [Two years]

      PedsQL™ 4.0 Generic Core or Infant Scales (self report)

    2. Health related quality of life (HRQOL) - Parent [Two years]

      PedsQL™ 4.0 Generic Core or Infant Scales (parent report)

    Secondary Outcome Measures

    1. Fatigue - Patient [Two Years]

      PedsQL™ Multidimensional Fatigue Scale v3.0 (self report)

    2. Fatigue - Parent [Two Years]

      PedsQL™ Multidimensional Fatigue Scale v3.0 (parent report)

    3. Sleep - Patient [Two Years]

      PROMIS Pediatric Sleep Disturbance - Short Form 4a and Pediatric Sleep-Related Impairment - Short Form 4a (self report)

    4. Sleep - Parent [Two Years]

      PROMIS Sleep Disturbance - Short Form 4a and Sleep-Related Impairment - Short Form 4a (parent report)

    5. Cognitive Functioning - Patient [Two Years]

      PedsQL™ Cognitive Functioning Scale and Pediatric Cerebral Performance Category (PCPC)

    6. Cognitive Functioning - Parent [Two Years]

      PedsQL™ Cognitive Functioning Scale (parent report) and Pediatric Cerebral Performance Category (PCPC) (parent report)

    7. Pain - Patient [Two Years]

      PedsQL™ Pediatric Pain Questionnaire and PROMIS Pediatric Pain Interference - Short Form 8a (self report)

    8. Post Traumatic Stress Disorder (PTSD)- Patient [Two Years]

      Child PTSD Symptom Scale for DSM-5 (CPSS-V) (self report)

    9. Post Traumatic Stress Disorder (PTSD)- Parent [Two Years]

      Young Child PTSD Screen - Revised PICU (YCPS R - PICU) (parent report); PTSD Checklist for DSM-5 (PCL-5) (parent report)

    10. Strengths and Difficulties - Patient [Two Years]

      Strengths and Difficulties Questionnaire (SDQ)

    11. Strengths and Difficulties - Sibling [Two Years]

      Strengths and Difficulties Questionnaire (SDQ)

    12. Hope - Patient [Two Years]

      Children's Hope Scale (CHS)

    13. Hope - Sibling [Two Years]

      Children's Hope Scale (CHS)

    14. Growth and Development - Patient [Two Years]

      Survey of Well-being of Young Children (SWYC) - Milestones only (parent report)

    15. Functional status - Patient [Two Years]

      Functional Status Scale (FSS) and Pediatric Overall Performance Category (POPC) (parent report)

    16. Family impact [Two years]

      PedsQL™ Family Impact Module v2.0 (parent report)

    17. Growth - Parent [Two Years]

      Post-traumatic Growth Inventory - Short Form (PTGI-SF) (parent self report)

    18. Depression - Parent [Two years]

      Patient Health Questionnaire-4 (PHQ-4) (parent self report)

    19. HRQOL - Sibling [Two Years]

      PedsQL Version 4.0 Generic Core Scales (sibling self report)

    20. Caregiving - Sibling [Two Years]

      Multidimensional Assessment of Caring Activities (MACA-YC18) (sibling self report)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 16 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alabama Children's Hospital Birmingham Alabama United States 35294
    2 Arkansas Children's Hospital Little Rock Arkansas United States 72202
    3 Annopinder Bhalla MD Los Angeles California United States 90027
    4 Lucille Packard Children's Hospital Stanford Palo Alto California United States 94304
    5 Children's Hospital Colorado Aurora Colorado United States 80045
    6 Connecticut Children's Medical Center Hartford Connecticut United States 06106
    7 Children's National Hospital Washington District of Columbia United States 20010
    8 Children's Hospital of Atlanta Atlanta Georgia United States 30342
    9 Ann & Robert H Lurie Children's Hospital of Chicago Chicago Illinois United States 60611
    10 Comer Children's Hospital Chicago Illinois United States 60637
    11 Riley Children's Health at Indiana University Indianapolis Indiana United States 46202
    12 Norton Children's Hospital Louisville Kentucky United States 40202
    13 Charlotte R Bloomberg Children's Center Baltimore Maryland United States 21287
    14 CS Mott Children's Hospital Detroit Michigan United States 48201
    15 Massonic Children's Hospital Minneapolis Minnesota United States 55454
    16 Mayo Clinic Rochester Minnesota United States 55905
    17 St Louis Children's Hospital Saint Louis Missouri United States 63110
    18 Dartmouth-Hitchcock Medical Center Lebanon New Hampshire United States 03756
    19 UNC Children's Hospital Chapel Hill Chapel Hill North Carolina United States 27599
    20 Brenner Children's Hospital Winston-Salem North Carolina United States 27157
    21 Rainbow Babies and Children's Hospital Cleveland Ohio United States 44106
    22 Nationwide Children's Hospital Columbus Ohio United States 43205
    23 Doernbecher Children's Hospital Portland Oregon United States 97239
    24 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
    25 LeBonheur Children's Hospital Memphis Tennessee United States 38103
    26 Dell Children's Medical Center of Central Texas Austin Texas United States 78723
    27 Children's Medical Center Dallas Dallas Texas United States 75390
    28 Texas Children's Hospital Houston Texas United States 77030
    29 Primary Children's Hospital Salt Lake City Utah United States 84113
    30 Children's Hospital of Richmond Richmond Virginia United States 23298
    31 Seattle Children's Hospital Seattle Washington United States 98101

    Sponsors and Collaborators

    • University of Pennsylvania
    • Seattle Children's Hospital
    • Boston Children's Hospital

    Investigators

    • Principal Investigator: Martha AQ Curley, RN, PhD, University of Pennsylvania
    • Principal Investigator: R. Scott Watson, MD, Seattle Children's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT04967365
    Other Study ID Numbers:
    • 843844
    First Posted:
    Jul 19, 2021
    Last Update Posted:
    Aug 9, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Syndrome
    Critical Illness

    Study Results

    No Results Posted as of Aug 9, 2021