This is a non-interventional study.: This is a non-interventional study.
Study summary
Improvement in pediatric intensive care unit (PICU) supportive care has led to improvement in clinical outcomes and decreased mortality in pediatric critical illness. However, PICU survivors are at risk of long-term health sequalae. Given the increased recognition of physical, cognitive, and psychological sequelae in PICU survivors, the concept of post-intensive care syndrome-pediatrics (PICS-p) has been proposed. Besides the PICU patient/survivor, the PICS-p framework also highlights the impacts of a child's critical illness has on the family. The impact of a PICU admission extends beyond the patient and parents, potentially affecting healthy siblings who are navigating their own developmental challenges. Healthy siblings may face emotional distress, increased responsibilities, and disruptions in their daily routines, all of which can contribute to long-term negative outcomes if unaddressed. Thus, this study consists of two cohorts to understand the long-term physical, cognitive, and psychological outcomes in PICU survivors and their families, and the short-term impacts on siblings of critically ill children.
Eligibility
Sex
ALL
Min age
28 Days
Max age
16 Years
Healthy volunteers
No
Inclusion Criteria:
\[HOPE Cohort\]
1. Between 28 days - 16 years of age at PICU admission
2. Have an expected PICU stay \> 48 hours\*
\[SHACK-S Cohort\]
1. Healthy children (aged 4 -16 years old) with critically ill sibling between 28 days - 16 years of age at PICU admission
2. Has a critically ill sibling who has an expected PICU stay \> 48 hours
3. Lives in the same household as the critically ill sibling and parents prior to admission
Exclusion Criteria:
\[HOPE Cohort\]
1. Do-Not-Resuscitate status
2. Lack of informed consent
3. Prior enrolment in this study
\[SHACK-S Cohort\]
1. Children of critically ill sibling with Do-Not-Resuscitate status
2. Children with condition listed on paediatric Complex Chronic Conditions (CCC) system Version 3.0 or with neurocognitive/neurodevelopmental delays or disorders
3. Previous admission to PICU
4. Lack of informed consent
5. Prior enrolment in this study
* Note: For participating study sites without a dedicated PICU (e.g., sites where patients are managed in a combined ward under High Dependency (HD) or ICU status), PICU stay will be defined as the duration during which the patient is assigned an ICU status. The determination of ICU status will be made at the discretion of the respective site's study team and Site-PI.
Primary outcome measure(s)
[HOPE] Pediatric Evaluation of Disability Inventory (PEDI-CAT) [Physical health outcomes of PICU survivors] — Baseline, Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge Measures functional domains: Daily Activities, Mobility, Social/Cognitive and Responsibility
[HOPE] Functional Status Scale (FSS) [Physical health outcomes of PICU survivors] — Baseline, Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge Measures 6 domains of functioning: Mental Status, Sensory, Communication, Motor Function, Feeding, Respiratory
[HOPE] Hand-grip strength test [Physical health outcomes of PICU survivors] — Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge Measures of maximum voluntary muscle strength (Only for study participants aged 6 years old and above)
[HOPE] 6-minute walk test [Physical health outcomes of PICU survivors] — Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge Assessment of aerobic capacity and endurance (Only for study participants aged 6 years old and above)
[HOPE] Developmental Profile-4 (DP-4) [Cognitive outcomes of PICU survivors] — Baseline, 6-, 12- and 18-month post-PICU discharge Measures developmental domains: Physical, Adaptive Behaviour, Social-Emotional, Cognitive and Communiation
[HOPE] Bayley Scales of Infant and Toddler Development - 4th edition (Bayley-4) [Cognitive outcomes of PICU survivors] — 6- and 18-month post-PICU discharge Measures developmental domains: Cognitive and Language (Only for study participants aged below 3 years old)
[HOPE] National Institute of Health Toolbox - Cognition Battery (NIHTB-CB) [Cognitive outcomes of PICU survivors] — Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge Measures cognitive health (Only for study participants aged 3 years old and above)
[HOPE] Strengths and Difficulty Questionnaire (SDQ) [Cognitive outcomes of PICU survivors] — Baseline, 6-, 12- and 18-month post-PICU discharge Screening tool for behavioural and emotional problems (Only for study participants aged 2 years old and above)
[SHACK-S] PedsQL 4.0 Short Form 15 (SF5) [Quality of Life in Siblings of Critically Ill Children] — PICU discharge, 1-, 3-, and 6-month post-PICU discharge Measures generic health-related quality of life in children
[SHACK-S] Strengths and Difficulties Questionnaire (SDQ) [Experiences and Support Needs of Siblings of Critically Ill Children] — 1-, 3-, and 6-month post-PICU discharge Screening tool for behavioural and emotional problems
[SHACK-S] Devereux Early Childhood Assessment for Preschoolers, Second Edition (DECA-P2) [Experiences and Support Needs of Siblings of Critically Ill Children] — 1-, 3-, and 6-month post-PICU discharge Measures of social and emotional health and resilience, and screening for behavioural concerns (For siblings ages 4-5 years old)
[SHACK-S] KidCOPE [Experiences and Support Needs of Siblings of Critically Ill Children] — 1-, 3-, and 6-month post-PICU discharge Measure of cogntive and behavioural coping in children and adolescents (For siblings ages 6-18 years old)
[SHACK-S] Semi-structured interview [Experiences and Support Needs of Siblings of Critically Ill Children] — 3- and 6-month post-PICU discharge To understand experiences and support needs of siblings of critically ill children
Trial sites (2)
Facility
City
Region
Status
National University Singapore
Singapore
Singapore
Recruiting
KK Women's and Children's Hospital
Singapore
Singapore
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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