Clinical trial NCT06812130: Surviving the Pediatric Intensive Care Unit (PICU)
Official title: Surviving the Pediatric Intensive Care Unit (PICU): Long-term Study to Understand and Improve Outcomes of PICU Survivors and Their Families
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post Intensive Care Syndrome (PICS)
Keywords: PICS-p
Prospective Observational Cohort Study
Post Intensive Care Syndrome in Paediatrics (PICS-p)
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
Collaborators: name: National University Hospital, Singapore
name: Duke-NUS Graduate Medical School
First posted: 2025-02-06
Enrollment: 404
Sex: ALL
Minimum age (years): 28
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: \[HOPE Cohort\] Paediatric patients, aged 28 days - 16 years of age, admitted to either PICU at KK Women's and Children's Hospital, Singapore or National University Hospital, Singapore.

\[SHACK-S Cohort\] Siblings, aged 4 - 16 years old, of paediatric patients admitted to either PICU at KK Women's and Children's Hospital, Singapore or National University Hospital, Singapore.

Brief 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.

Detailed description: The objectives of Helping to Optimize Patients' Experiences (HOPE) after Pediatric Critical Illness Cohort Study are:

1. \[Primary\] To characterize physical and cognitive health outcomes of PICU survivors.
2. \[Primary\] To investigate subgroups of critically ill children who have poor medium-term physical and cognitive health outcomes.
3. \[Primary\] To elucidate risk factors for poor physical and cognitive health outcomes in PICU survivors.
4. \[Exploratory\] To investigate the impact of physical and cognitive health of PICU survivors on overall family health.

The objectives of Singapore Health outcomes After Critical illness in Kids - Siblings (SHACK-S): Health Outcomes and Experiences of Healthy Siblings in the first 6 months after PICU discharge are:

1. \[Primary\] To describe and compare quality-of-life in healthy siblings at 1, 3 and 6 months after PICU discharge.
2. \[Primary\] To explore the experiences and support needs of healthy siblings 6 months after PICU discharge of a critically ill child.
3. \[Secondary\] To examine the experiences of recovery trajectory of healthy siblings.

Thus, HOPE cohort will provide information and insight regarding which groups of PICU patients and associated PICU therapies are associated with the highest risk for poor survivorship. The conduct of this study will also allow us to identify the challenges and find appropriate solutions in performing a cohort study with an emphasis on patient-reported outcomes (e.g., functional status, cognition and quality of life). Concurrently, the SHACK-S cohort will provide insights to understand the impacts of PICU admission on siblings and their recovery.

Eligibility criteria: 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

Primary outcomes:
measure: [HOPE] Pediatric Evaluation of Disability Inventory (PEDI-CAT) [Physical health outcomes of PICU survivors]
timeFrame: Baseline, Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge
measure: [HOPE] Functional Status Scale (FSS) [Physical health outcomes of PICU survivors]
timeFrame: Baseline, Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge
measure: [HOPE] Hand-grip strength test [Physical health outcomes of PICU survivors]
timeFrame: Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge
measure: [HOPE] 6-minute walk test [Physical health outcomes of PICU survivors]
timeFrame: Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge
measure: [HOPE] Developmental Profile-4 (DP-4) [Cognitive outcomes of PICU survivors]
timeFrame: Baseline, 6-, 12- and 18-month post-PICU discharge
measure: [HOPE] Bayley Scales of Infant and Toddler Development - 4th edition (Bayley-4) [Cognitive outcomes of PICU survivors]
timeFrame: 6- and 18-month post-PICU discharge
measure: [HOPE] National Institute of Health Toolbox - Cognition Battery (NIHTB-CB) [Cognitive outcomes of PICU survivors]
timeFrame: Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge
measure: [HOPE] Strengths and Difficulty Questionnaire (SDQ) [Cognitive outcomes of PICU survivors]
timeFrame: Baseline, 6-, 12- and 18-month post-PICU discharge
measure: [SHACK-S] PedsQL 4.0 Short Form 15 (SF5) [Quality of Life in Siblings of Critically Ill Children]
timeFrame: PICU discharge, 1-, 3-, and 6-month post-PICU discharge
measure: [SHACK-S] Strengths and Difficulties Questionnaire (SDQ) [Experiences and Support Needs of Siblings of Critically Ill Children]
timeFrame: 1-, 3-, and 6-month post-PICU discharge
measure: [SHACK-S] Devereux Early Childhood Assessment for Preschoolers, Second Edition (DECA-P2) [Experiences and Support Needs of Siblings of Critically Ill Children]
timeFrame: 1-, 3-, and 6-month post-PICU discharge
measure: [SHACK-S] KidCOPE [Experiences and Support Needs of Siblings of Critically Ill Children]
timeFrame: 1-, 3-, and 6-month post-PICU discharge
measure: [SHACK-S] Semi-structured interview [Experiences and Support Needs of Siblings of Critically Ill Children]
timeFrame: 3- and 6-month post-PICU discharge
Secondary outcomes:
measure: [HOPE] PedsQL 1.0 Infant Scales [Overall Family Health]
timeFrame: Baseline, Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge
measure: [HOPE] PedsQL 4.0 Short Form 15 (SF15) [Overall Family Health]
timeFrame: Baseline, Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge
measure: [HOPE] PedsQL 3.0 Cognitive Functioning Scales [Overall Family Health]
timeFrame: Baseline, Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge
measure: [HOPE] PedsQL 2.0 Family Impact Module [Overall Family Health]
timeFrame: Baseline, Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge
measure: [HOPE] Patient Health Questionnaire-4 (PHQ-4) [Overall Family Health]
timeFrame: PICU discharge, Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge
measure: [HOPE] PTSD Checklist for DSM-5 [Overall Family Health]
timeFrame: 6-, 12- and 18-month post-PICU discharge
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Singapore
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: A/Prof Lee Jan Hau, MBBS, MRCPCH, MCI
role: PRINCIPAL_INVESTIGATOR
References: