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出境医 / 临床实验 / 重症监护后综合征 - 儿科 (PICS-p)：纵向队列研究 (PICS-p)
重症监护后综合征 - 儿科 (PICS-p)：纵向队列研究 (PICS-p)
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 |
|---|
| Critical Illness Post Intensive Care Unit Syndrome |
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 |
| Estimated 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 : | July 27, 2021 |
| Estimated Primary Completion Date : | June 30, 2025 |
| Estimated Study Completion Date : | June 30, 2025 |
Arms and Interventions
| Group/Cohort |
|---|
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Case patients
500 patients who experience greater than or equal to 3 nights in a pediatric ICU with intensive care instrumentation.
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Control patients
250 patients who experience an overnight stay in a pediatric ICU without intensive care instrumentation.
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Outcome Measures
Primary Outcome Measures :
- Health related quality of life (HRQOL) - Patient [ Time Frame: Two years ]PedsQL™ 4.0 Generic Core or Infant Scales (self report)
- Health related quality of life (HRQOL) - Parent [ Time Frame: Two years ]PedsQL™ 4.0 Generic Core or Infant Scales (parent report)
Secondary Outcome Measures :
- Fatigue - Patient [ Time Frame: Two Years ]PedsQL™ Multidimensional Fatigue Scale v3.0 (self report)
- Fatigue - Parent [ Time Frame: Two Years ]PedsQL™ Multidimensional Fatigue Scale v3.0 (parent report)
- Sleep - Patient [ Time Frame: Two Years ]PROMIS Pediatric Sleep Disturbance - Short Form 4a and Pediatric Sleep-Related Impairment - Short Form 4a (self report)
- Sleep - Parent [ Time Frame: Two Years ]PROMIS Sleep Disturbance - Short Form 4a and Sleep-Related Impairment - Short Form 4a (parent report)
- Cognitive Functioning - Patient [ Time Frame: Two Years ]PedsQL™ Cognitive Functioning Scale and Pediatric Cerebral Performance Category (PCPC)
- Cognitive Functioning - Parent [ Time Frame: Two Years ]PedsQL™ Cognitive Functioning Scale (parent report) and Pediatric Cerebral Performance Category (PCPC) (parent report)
- Pain - Patient [ Time Frame: Two Years ]PedsQL™ Pediatric Pain Questionnaire and PROMIS Pediatric Pain Interference - Short Form 8a (self report)
- Post Traumatic Stress Disorder (PTSD)- Patient [ Time Frame: Two Years ]Child PTSD Symptom Scale for DSM-5 (CPSS-V) (self report)
- Post Traumatic Stress Disorder (PTSD)- Parent [ Time Frame: Two Years ]Young Child PTSD Screen - Revised PICU (YCPS R - PICU) (parent report); PTSD Checklist for DSM-5 (PCL-5) (parent report)
- Strengths and Difficulties - Patient [ Time Frame: Two Years ]Strengths and Difficulties Questionnaire (SDQ)
- Strengths and Difficulties - Sibling [ Time Frame: Two Years ]Strengths and Difficulties Questionnaire (SDQ)
- Hope - Patient [ Time Frame: Two Years ]Children's Hope Scale (CHS)
- Hope - Sibling [ Time Frame: Two Years ]Children's Hope Scale (CHS)
- Growth and Development - Patient [ Time Frame: Two Years ]Survey of Well-being of Young Children (SWYC) - Milestones only (parent report)
- Functional status - Patient [ Time Frame: Two Years ]Functional Status Scale (FSS) and Pediatric Overall Performance Category (POPC) (parent report)
- Family impact [ Time Frame: Two years ]PedsQL™ Family Impact Module v2.0 (parent report)
- Growth - Parent [ Time Frame: Two Years ]Post-traumatic Growth Inventory - Short Form (PTGI-SF) (parent self report)
- Depression - Parent [ Time Frame: Two years ]Patient Health Questionnaire-4 (PHQ-4) (parent self report)
- HRQOL - Sibling [ Time Frame: Two Years ]PedsQL Version 4.0 Generic Core Scales (sibling self report)
- Caregiving - Sibling [ Time Frame: Two Years ]Multidimensional Assessment of Caring Activities (MACA-YC18) (sibling self report)
Eligibility Criteria
| Ages Eligible for Study: | 1 Month to 16 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Pediatric patents surviving a pediatric intensive care unit hospitalization
Criteria
Case 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)
Case Exclusion criteria:
- 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.
Contacts and Locations
Contacts
| Contact: Martha AQ Curley, RN, PhD | 215-573-9449 | curley@upenn.edu | |
| Contact: Amy M Cassidy | 215-898-4151 | acassidy@upenn.edu |
Locations
Show 31 study locations
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 |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | June 28, 2021 | ||||||||
| First Posted Date | July 19, 2021 | ||||||||
| Last Update Posted Date | August 9, 2021 | ||||||||
| Actual Study Start Date | July 27, 2021 | ||||||||
| Estimated Primary Completion Date | June 30, 2025 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Post-Intensive Care Syndrome - Pediatrics (PICS-p): Longitudinal Cohort Study | ||||||||
| Official Title | Post-Intensive Care Syndrome - Pediatrics (PICS-p): Longitudinal Cohort Study | ||||||||
| 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. | ||||||||
| 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 Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Pediatric patents surviving a pediatric intensive care unit hospitalization | ||||||||
| Condition |
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| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
750 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | June 30, 2025 | ||||||||
| Estimated Primary Completion Date | June 30, 2025 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Case Inclusion criteria:
Case Exclusion criteria:
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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| Sex/Gender |
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| Ages | 1 Month to 16 Years (Child) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04967365 | ||||||||
| Other Study ID Numbers | 843844 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | University of Pennsylvania | ||||||||
| Study Sponsor | University of Pennsylvania | ||||||||
| Collaborators |
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| Investigators |
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| PRS Account | University of Pennsylvania | ||||||||
| Verification Date | August 2021 | ||||||||