Surviving the Pediatric Intensive Care Unit (PICU)

Surviving the Pediatric Intensive Care Unit (PICU): Long-term Study to Understand and Improve Outcomes of PICU Survivors and Their Families

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.

Study Overview

• Status: Recruiting
• Conditions: Post Intensive Care Syndrome (PICS)
• Intervention / Treatment: Other: This is a non-interventional study.

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.

• Study Type: Observational
• Enrollment (Estimated): 404

Contacts and Locations

• Study Contact: Name: Eric Jia Yong Ong, BSc (Hons); Phone Number: +65 62255554; Email: eric.ong.j.y@kkh.com.sg

Study Locations

• Singapore
  • Singapore
    • Singapore, Singapore, Singapore, 229899
      • Recruiting
      • KK Women's and Children's Hospital
      • Contact: Eric Jia Yong Ong, BSc (Hons); Email: eric.ong.j.y@kkh.com.sg
      • Principal Investigator: A/Prof Lee Jan Hau, MBBS, MRCPCH, MCI
      • Principal Investigator: Pei Fen Poh, PhD
      • Sub-Investigator: Christelle Xian-Ting Tan, MBBS, MRCPCH,MMed, FAMS, PGDip
      • Sub-Investigator: Joel Kian Boon Lim, MBBS, MRCPCH, MMed (Paeds)
      • Sub-Investigator: Judith Ju-Ming Wong, MBBCh BAO, MRCPCH, MCI
      • Sub-Investigator: Rehena Sultana, MSc
      • Sub-Investigator: Liying Yang, MSc
      • Sub-Investigator: Phey Hong Yang, M.Ed., DPsych (Clinical)
      • Sub-Investigator: Eric Jia Yong Ong, BSc (Hons)
      • Sub-Investigator: Wen Yi Wan
      • Sub-Investigator: Kathy Chiew Suan Liaw
      • Sub-Investigator: Shi Hua Chan, MBBS, MRCPCH, MMed (Paeds)
      • Sub-Investigator: Chloe Ann Cheang, MBBS
    • Singapore, Singapore, Singapore, 119074
      • Recruiting
      • National University Singapore
      • Contact: Dr Fan Lijia, MBBS, MMed, MRCPCH; Email: li_jia_fan@nuhs.edu.sg
      • Principal Investigator: Lijia Fan, MBBS, MMed, MRCPCH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.; 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.; This is a non-interventional study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
[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] 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
[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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
[HOPE] PedsQL 1.0 Infant Scales [Overall Family Health]	Measure generic health-related quality of life in infants (Only for study participants aged below 2 years old)	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]	Measure generic health-related quality of life in children (Only for study participants aged 2 - 16 years old)	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]	Measures cognitive functioning in paediatric patients (Only for study participants aged 2 - 16 years old)	Baseline, Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge
[HOPE] PedsQL 2.0 Family Impact Module [Overall Family Health]	Measures the impact of pediatric chronic health conditions on parents and the family	Baseline, Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge
[HOPE] Patient Health Questionnaire-4 (PHQ-4) [Overall Family Health]	Brief screener for depression and anxiety (in parent)	PICU discharge, Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge
[HOPE] PTSD Checklist for DSM-5 [Overall Family Health]	Parent self-report measure of DSM-5 symptoms of PTSD	6-, 12- and 18-month post-PICU discharge
[HOPE] Young Child PTSD Screen / Child and Adolescent PTSD Screen [Overall Family Health]	Brief screening for PTSD symptoms (Children)	6-, 12- and 18-month post-PICU discharge

Collaborators and Investigators

• Sponsor: KK Women's and Children's Hospital
• Collaborators: National University Hospital, Singapore; Duke-NUS Graduate Medical School; Singapore Clinical Research Institute
• Investigators: Principal Investigator: A/Prof Lee Jan Hau, MBBS, MRCPCH, MCI, KK Women's and Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 16, 2025
• First Submitted That Met QC Criteria: February 2, 2025
• First Posted (Actual): February 6, 2025

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: PICS-p; Prospective Observational Cohort Study; Post Intensive Care Syndrome in Paediatrics (PICS-p)
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; postintensive care syndrome
• Other Study ID Numbers: ECOS Ref: 2024-3978

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No