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Critical IllnessPICS-pNCT04967365

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

An observational study of Critical Illness and Post Intensive Care Unit Syndrome, run by University of Pennsylvania at 30 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 1 month to 16 years
How many people
755 participants
Where
30 sitesUnited States
Study dates
27 Jul 2021to 30 Jun 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 month to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Pediatric patents surviving a pediatric intensive care unit hospitalization

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.

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

United States30 sites

  • Children's Hospital of Atlanta

    Atlanta, Georgia, 30342

  • Children's Hospital Colorado

    Aurora, Colorado, 80045

  • Dell Children's Medical Center of Central Texas

    Austin, Texas, 78723

  • Charlotte R Bloomberg Children's Center

    Baltimore, Maryland, 21287

  • Alabama Children's Hospital

    Birmingham, Alabama, 35294

  • UNC Children's Hospital Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Ann & Robert H Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611

  • Comer Children's Hospital

    Chicago, Illinois, 60637

  • Rainbow Babies and Children's Hospital

    Cleveland, Ohio, 44106

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

  • Children's Medical Center Dallas

    Dallas, Texas, 75390

  • CS Mott Children's Hospital

    Detroit, Michigan, 48201

  • Texas Children's Hospital

    Houston, Texas, 77030

  • Riley Children's Health at Indiana University

    Indianapolis, Indiana, 46202

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202

  • Annopinder Bhalla MD

    Los Angeles, California, 90027

  • Norton Children's Hospital

    Louisville, Kentucky, 40202

  • LeBonheur Children's Hospital

    Memphis, Tennessee, 38103

  • Massonic Children's Hospital

    Minneapolis, Minnesota, 55454

  • Lucille Packard Children's Hospital Stanford

    Palo Alto, California, 94304

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Doernbecher Children's Hospital

    Portland, Oregon, 97239

  • Children's Hospital of Richmond

    Richmond, Virginia, 23298

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Primary Children's Hospital

    Salt Lake City, Utah, 84113

  • Seattle Children's Hospital

    Seattle, Washington, 98101

  • St Louis Children's Hospital

    St Louis, Missouri, 63110

  • Children's National Hospital

    Washington D.C., District of Columbia, 20010

  • Brenner Children's Hospital

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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.

Read the 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.

Medical subject headings
Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04967365
Study groupRoleWhat they receive
Case patients500 patients who experience greater than or equal to 3 nights in a pediatric ICU with intensive care instrumentation.
Control patients250 patients who experience an overnight stay in a pediatric ICU without intensive care instrumentation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Health related quality of life (HRQOL) - Patient

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

    Measured: Two years

  2. Health related quality of life (HRQOL) - Parent

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

    Measured: Two years

Secondary outcomes (20)

  1. Fatigue - Patient

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

    Measured: Two Years

  2. Fatigue - Parent

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

    Measured: Two Years

  3. Sleep - Patient

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

    Measured: Two Years

  4. Sleep - Parent

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

    Measured: Two Years

  5. Cognitive Functioning - Patient

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

    Measured: Two Years

  6. Cognitive Functioning - Parent

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

    Measured: Two Years

  7. Pain - Patient

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

    Measured: Two Years

  8. Post Traumatic Stress Disorder (PTSD)- Patient

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

    Measured: Two Years

  9. 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)

    Measured: Two Years

  10. Strengths and Difficulties - Patient

    Strengths and Difficulties Questionnaire (SDQ)

    Measured: Two Years

  11. Strengths and Difficulties - Sibling

    Strengths and Difficulties Questionnaire (SDQ)

    Measured: Two Years

  12. Hope - Patient

    Children's Hope Scale (CHS)

    Measured: Two Years

  13. Hope - Sibling

    Children's Hope Scale (CHS)

    Measured: Two Years

  14. Growth and Development - Patient

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

    Measured: Two Years

  15. Functional status - Patient

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

    Measured: Two Years

  16. Family impact

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

    Measured: Two years

  17. Growth - Parent

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

    Measured: Two Years

  18. Depression - Parent

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

    Measured: Two years

  19. HRQOL - Sibling

    PedsQL Version 4.0 Generic Core Scales (sibling self report)

    Measured: Two Years

  20. Caregiving - Sibling

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

    Measured: Two Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2021
  2. Study start27 Jul 2021
  3. Primary completion31 Jan 2026
  4. Study completion30 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
755 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04967365
Sponsor's protocol ID
843844
Acronym
PICS-p
Status last verified
Aug 2026
First submitted
28 Jun 2021
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38401903

Questions about this trial

What is this clinical trial studying?

An observational study of Critical Illness and Post Intensive Care Unit Syndrome, run by University of Pennsylvania at 30 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health related quality of life (HRQOL) - Patient (time frame: Two years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04967365, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.

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