Surviving the Pediatric Intensive Care Unit (PICU)

NCT06812130 | Recruiting

• 1 other identifier: ECOS Ref: 2024-3978
• Study Type: observational
• Target: 404
• Locations: 1 country
• Sites: 2

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.

Conditions

Post Intensive Care Syndrome (PICS)

Keywords

PICS-p; Prospective Observational Cohort Study; Post Intensive Care Syndrome in Paediatrics (PICS-p)

Outcome Measures

Primary Outcomes (13)

• [HOPE] Pediatric Evaluation of Disability Inventory (PEDI-CAT) [Physical health outcomes of PICU survivors]

  Measures functional domains: Daily Activities, Mobility, Social/Cognitive and Responsibility

  Baseline, Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge

• [HOPE] Functional Status Scale (FSS) [Physical health outcomes of PICU survivors]

  Measures 6 domains of functioning: Mental Status, Sensory, Communication, Motor Function, Feeding, Respiratory

  Baseline, Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge

• [HOPE] Hand-grip strength test [Physical health outcomes of PICU survivors]

  Measures of maximum voluntary muscle strength (Only for study participants aged 6 years old and above)

  Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge

• [HOPE] 6-minute walk test [Physical health outcomes of PICU survivors]

  Assessment of aerobic capacity and endurance (Only for study participants aged 6 years old and above)

  Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge

• [HOPE] Developmental Profile-4 (DP-4) [Cognitive outcomes of PICU survivors]

  Measures developmental domains: Physical, Adaptive Behaviour, Social-Emotional, Cognitive and Communiation

  Baseline, 6-, 12- and 18-month post-PICU discharge

• [HOPE] Bayley Scales of Infant and Toddler Development - 4th edition (Bayley-4) [Cognitive outcomes of PICU survivors]

  Measures developmental domains: Cognitive and Language (Only for study participants aged below 3 years old)

  6- and 18-month post-PICU discharge

• [HOPE] National Institute of Health Toolbox - Cognition Battery (NIHTB-CB) [Cognitive outcomes of PICU survivors]

  Measures cognitive health (Only for study participants aged 3 years old and above)

  Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge

• [HOPE] Strengths and Difficulty Questionnaire (SDQ) [Cognitive outcomes of PICU survivors]

  Screening tool for behavioural and emotional problems (Only for study participants aged 2 years old and above)

  Baseline, 6-, 12- and 18-month post-PICU discharge

• [SHACK-S] PedsQL 4.0 Short Form 15 (SF5) [Quality of Life in Siblings of Critically Ill Children]

  Measures generic health-related quality of life in children

  PICU discharge, 1-, 3-, and 6-month post-PICU discharge

• [SHACK-S] Strengths and Difficulties Questionnaire (SDQ) [Experiences and Support Needs of Siblings of Critically Ill Children]

  Screening tool for behavioural and emotional problems

  1-, 3-, and 6-month post-PICU discharge

• [SHACK-S] Devereux Early Childhood Assessment for Preschoolers, Second Edition (DECA-P2) [Experiences and Support Needs of Siblings of Critically Ill Children]

  Measures of social and emotional health and resilience, and screening for behavioural concerns (For siblings ages 4-5 years old)

  1-, 3-, and 6-month post-PICU discharge

• [SHACK-S] KidCOPE [Experiences and Support Needs of Siblings of Critically Ill Children]

  Measure of cogntive and behavioural coping in children and adolescents (For siblings ages 6-18 years old)

  1-, 3-, and 6-month post-PICU discharge

• [SHACK-S] Semi-structured interview [Experiences and Support Needs of Siblings of Critically Ill Children]

  To understand experiences and support needs of siblings of critically ill children

  3- and 6-month post-PICU discharge

Secondary Outcomes (7)

• [HOPE] PedsQL 1.0 Infant Scales [Overall Family Health]

  Baseline, Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge

• [HOPE] PedsQL 4.0 Short Form 15 (SF15) [Overall Family Health]

  Baseline, Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge

• [HOPE] PedsQL 3.0 Cognitive Functioning Scales [Overall Family Health]

  Baseline, Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge

• [HOPE] Young Child PTSD Screen / Child and Adolescent PTSD Screen [Overall Family Health]

  6-, 12- and 18-month post-PICU discharge

• [HOPE] PedsQL 2.0 Family Impact Module [Overall Family Health]

  Baseline, Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge

Study Arms (2)

HOPE Cohort (PICU Survivors)

Helping to Optimize Patients' Experiences (HOPE) after Pediatric Critical Illness Cohort Study \[Sample Size: 240 participants\]

Other: This is a non-interventional study.

SHACK-S Cohort (Siblings of PICU Survivors)

Singapore Health outcomes After Critical illness in Kids - Siblings (SHACK-S): Experiences and Health Outcomes of Siblings in the first 6 months after PICU discharge of a critically ill child. \[Sample Size (Quantitative): 164 participants; Sample Size (Qualitative): 20 participants\]

Other: This is a non-interventional study.

Interventions

This is a non-interventional study. OTHER

This is a non-interventional study.

HOPE Cohort (PICU Survivors); SHACK-S Cohort (Siblings of PICU Survivors)

Eligibility Criteria

• Age: 28 Days - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• \[HOPE Cohort\]
• Between 28 days - 16 years of age at PICU admission
• Have an expected PICU stay \> 48 hours\*
• \[SHACK-S Cohort\]
• Healthy children (aged 4 -16 years old) with critically ill sibling between 28 days - 16 years of age at PICU admission
• Has a critically ill sibling who has an expected PICU stay \> 48 hours
• Lives in the same household as the critically ill sibling and parents prior to admission

You may not qualify if:

• \[HOPE Cohort\]
• Do-Not-Resuscitate status
• Lack of informed consent
• Prior enrolment in this study
• \[SHACK-S Cohort\]
• Children of critically ill sibling with Do-Not-Resuscitate status
• Children with condition listed on paediatric Complex Chronic Conditions (CCC) system Version 3.0 or with neurocognitive/neurodevelopmental delays or disorders
• Previous admission to PICU
• Lack of informed consent
• 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.

Sponsors & Collaborators

• Singapore Clinical Research Institute: collaborator
• KK Women's and Children's Hospital: lead
• National University Hospital, Singapore: collaborator
• Duke-NUS Graduate Medical School: collaborator

Study Sites (2)

National University Singapore

Singapore, Singapore, 119074, Singapore

RECRUITING

KK Women's and Children's Hospital

Singapore, Singapore, 229899, Singapore

RECRUITING

MeSH Terms

Conditions

postintensive care syndrome

Study Officials

• A/Prof Lee Jan Hau, MBBS, MRCPCH, MCI

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Jia Yong Ong, BSc (Hons)

CONTACT

+65 62255554; eric.ong.j.y@kkh.com.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: February 6, 2025
• Study Start: February 11, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)