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RecruitingNCT06812130Updated May 5, 2026

Surviving the Pediatric Intensive Care Unit (PICU)

An observational study in Post Intensive Care Syndrome (PICS), sponsored by KK Women's and Children's Hospital. Recruiting at 2 sites in Singapore. Open to participants aged 28 Days to 16 Years. Per ClinicalTrials.gov, last updated 2026-05-05.

Sponsored by KK Women's and Children's Hospital · Observational

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
404
Ages
28 Days to 16 Years
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • Post Intensive Care Syndrome (PICS)

Keywords

  • PICS-p
  • Prospective Observational Cohort Study
  • Post Intensive Care Syndrome in Paediatrics (PICS-p)
03

In context

postintensive care syndrome

45 studies on the registry are indexed under postintensive care syndrome; 27 are open to participants now.

This study's planned enrollment of 404 is above the median of 300 across 21 observational studies indexed under postintensive care syndrome.

Browse postintensive care syndrome studies →

Lead sponsor

KK Women's and Children's Hospital is the lead sponsor of 136 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
28 Days to 16 Years
Sexes eligible
All
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
404 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherThis is a non-interventional study.

    This is a non-interventional study.

06

What researchers measure

Primary outcomes

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

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

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

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

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

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

  3. [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)

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

  4. [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)

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

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

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

    Time frame: Baseline, 6-, 12- and 18-month post-PICU discharge

  6. [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)

    Time frame: 6- and 18-month post-PICU discharge

  7. [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)

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

  8. [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)

    Time frame: Baseline, 6-, 12- and 18-month post-PICU discharge

  9. [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

    Time frame: PICU discharge, 1-, 3-, and 6-month post-PICU discharge

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

    Screening tool for behavioural and emotional problems

    Time frame: 1-, 3-, and 6-month post-PICU discharge

  11. [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)

    Time frame: 1-, 3-, and 6-month post-PICU discharge

  12. [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)

    Time frame: 1-, 3-, and 6-month post-PICU discharge

  13. [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

    Time frame: 3- and 6-month post-PICU discharge

Secondary outcomes

  1. [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)

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

  2. [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)

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

  3. [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)

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

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

    Brief screening for PTSD symptoms (Children)

    Time frame: 6-, 12- and 18-month post-PICU discharge

  5. [HOPE] PedsQL 2.0 Family Impact Module [Overall Family Health]

    Measures the impact of pediatric chronic health conditions on parents and the family

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

  6. [HOPE] Patient Health Questionnaire-4 (PHQ-4) [Overall Family Health]

    Brief screener for depression and anxiety (in parent)

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

  7. [HOPE] PTSD Checklist for DSM-5 [Overall Family Health]

    Parent self-report measure of DSM-5 symptoms of PTSD

    Time frame: 6-, 12- and 18-month post-PICU discharge

07

Study locations

2 of 2 sites recruiting
  • National University Singapore
    Singapore, Singapore 119074, Singapore
    • Dr Fan Lijia, MBBS, MMed, MRCPCH · Contact · li_jia_fan@nuhs.edu.sg
    • Lijia Fan, MBBS, MMed, MRCPCH · Principal investigator
    Recruiting
  • KK Women's and Children's Hospital
    Singapore, Singapore 229899, Singapore
    • Eric Jia Yong Ong, BSc (Hons) · Contact · eric.ong.j.y@kkh.com.sg
    • A/Prof Lee Jan Hau, MBBS, MRCPCH, MCI · Principal investigator
    • Pei Fen Poh, PhD · Principal 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 · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06812130
Lead sponsor
KK Women's and Children's Hospital
Collaborators
National University Hospital, Singapore, Duke-NUS Graduate Medical School, Singapore Clinical Research Institute
Responsible party
Jan Hau Lee (Associate Professor, KK Women's and Children's Hospital) — Principal investigator
First posted
Feb 6, 2025
Start date
Feb 11, 2025
Primary completion
Jun 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
May 5, 2026

Study contacts

Eric Jia Yong Ong, BSc (Hons)
Contact
eric.ong.j.y@kkh.com.sg
+65 62255554
A/Prof Lee Jan Hau, MBBS, MRCPCH, MCI
principal investigator · KK Women's and Children's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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