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Post Intensive Care Syndrome (PICS)NCT06812130

Surviving the Pediatric Intensive Care Unit (PICU)

An observational study of Post Intensive Care Syndrome (PICS), run by KK Women's and Children's Hospital at 2 sites in Singapore.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 28 days to 16 years
Conditions the study is for
Post Intensive Care Syndrome (PICS)
What is being tested?
This is a non-interventional study.
How many people
404 participants
Where
2 sitesSingapore
Study dates
11 Feb 2025to Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 28 days to 16 years
  • All sexes
  • No healthy volunteers
  • Child

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.

Who may be able to join

  • [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

Who cannot join

  • [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
Show all 11Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Eric Jia Yong Ong, BSc (Hons) contact

+65 62255554

eric.ong.j.y@kkh.com.sg

Singapore2 sites, 2 recruiting

  • National University Singapore

    Singapore, Singapore, 119074

    Dr Fan Lijia, MBBS, MMed, MRCPCH, li_jia_fan@nuhs.edu.sg

    Lijia Fan, MBBS, MMed, MRCPCH

    Recruiting

  • KK Women's and Children's Hospital

    Singapore, Singapore, 229899

    Eric Jia Yong Ong, BSc (Hons), eric.ong.j.y@kkh.com.sg

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

    Recruiting

Other trials in Singapore

About this study

Official title: 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.

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.

Being tested
This is a non-interventional study.
Keywords
PICS-p, Prospective Observational Cohort Study, Post Intensive Care Syndrome in Paediatrics (PICS-p)
Medical subject headings
postintensive care syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • This is a non-interventional study.Other

    This is a non-interventional study.

Study groups in NCT06812130
Study groupRoleWhat they receive
HOPE Cohort (PICU Survivors)Helping to Optimize Patients' Experiences (HOPE) after Pediatric Critical Illness Cohort Study [Sample Size: 240 participants]
Receives: 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]
Receives: Other: This is a non-interventional study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: 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)

    Measured: 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)

    Measured: 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

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: 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)

    Measured: 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

    Measured: 3- and 6-month post-PICU discharge

Secondary outcomes (7)

  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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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

    Measured: 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)

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2025
  2. Study start11 Feb 2025
  3. Primary completionJun 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
404 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06812130
Sponsor's protocol ID
ECOS Ref: 2024-3978
Status last verified
Apr 2026
First submitted
16 Jan 2025
Last updated
5 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Post Intensive Care Syndrome (PICS), run by KK Women's and Children's Hospital at 2 sites in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eric Jia Yong Ong, BSc (Hons) (+65 62255554, eric.ong.j.y@kkh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

[HOPE] Pediatric Evaluation of Disability Inventory (PEDI-CAT) [Physical health outcomes of PICU survivors] (time frame: Baseline, Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06812130.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

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