Post-Intensive Care Syndrome - Pediatrics (PICS-p): Longitudinal Cohort Study (NCT04967365) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Post-Intensive Care Syndrome - Pediatrics (PICS-p): Longitudinal Cohort Study
United States755 participantsStarted 2021-07-27
Plain-language 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.
Who can participate
Age range
1 Month – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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)
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is actively following patients but no longer enrolling new participants, is there any chance my child could still be included, or are there similar ongoing studies we should look into instead?
2This study is tracking health-related quality of life for both the child and the parent after a pediatric ICU stay — what does that actually mean in practice, and would we be reporting on my child's day-to-day functioning over time?
3Since this is a longitudinal cohort study with no assigned treatment, how might participating affect my child's care, and would it just involve surveys and follow-up visits rather than any medical interventions?
4Post-Intensive Care Syndrome in children can affect things like thinking, emotions, and physical recovery — based on what this study is measuring, what signs should we be watching for in my child after their ICU stay?
5Are there any clinical programs or interventions already available for children showing signs of PICS-p that we should be discussing now, rather than waiting to see if a study like this leads to future recommendations?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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)