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New study tracks Kids' recovery after intensive care

NCT ID NCT04967365

Knowledge-focused Sponsor: University of Pennsylvania Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 07, 2026 · Updated 3 times

Summary

This study follows 755 children who were in the pediatric intensive care unit (PICU) to learn how they recover physically, mentally, and emotionally. Researchers will track quality of life, fatigue, and sleep over time. The goal is to understand what helps children and families heal, so better support can be designed in the future.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could reveal what helps children recover best after a critical illness, pointing toward better support programs.
What could go wrong
This is an observational study, not a treatment trial. It cannot prove what works, only describe patterns. Results may not apply to all children.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

755 people

The number who actually took part.

Started

Jul 2021

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Pediatric patents surviving a pediatric intensive care unit hospitalization

Ages

1 month to 16 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Critical Illness

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Critical illness Post intensive care unit syndrome

Contacts and locations

Locations

  • Alabama Children's Hospital

    Birmingham, Alabama, 35294, United States

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

    Chicago, Illinois, 60611, United States

  • Annopinder Bhalla MD

    Los Angeles, California, 90027, United States

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202, United States

  • Brenner Children's Hospital

    Winston-Salem, North Carolina, 27157, United States

  • CS Mott Children's Hospital

    Detroit, Michigan, 48201, United States

  • Charlotte R Bloomberg Children's Center

    Baltimore, Maryland, 21287, United States

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Atlanta

    Atlanta, Georgia, 30342, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Hospital of Richmond

    Richmond, Virginia, 23298, United States

  • Children's Medical Center Dallas

    Dallas, Texas, 75390, United States

  • Children's National Hospital

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

  • Comer Children's Hospital

    Chicago, Illinois, 60637, United States

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • Dell Children's Medical Center of Central Texas

    Austin, Texas, 78723, United States

  • Doernbecher Children's Hospital

    Portland, Oregon, 97239, United States

  • LeBonheur Children's Hospital

    Memphis, Tennessee, 38103, United States

  • Lucille Packard Children's Hospital Stanford

    Palo Alto, California, 94304, United States

  • Massonic Children's Hospital

    Minneapolis, Minnesota, 55454, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Norton Children's Hospital

    Louisville, Kentucky, 40202, United States

  • Primary Children's Hospital

    Salt Lake City, Utah, 84113, United States

  • Rainbow Babies and Children's Hospital

    Cleveland, Ohio, 44106, United States

  • Riley Children's Health at Indiana University

    Indianapolis, Indiana, 46202, United States

  • Seattle Children's Hospital

    Seattle, Washington, 98101, United States

  • St Louis Children's Hospital

    St Louis, Missouri, 63110, United States

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

  • UNC Children's Hospital Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

More trials for these conditions

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