RecruitingNot Applicable

Surviving the Pediatric Intensive Care Unit (PICU)

Singapore404 participantsStarted 2025-02-11

Plain-language 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.

Who can participate

Age range

28 Days – 16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Between 28 days - 16 years of age at PICU admission
. Have an expected PICU stay \> 48 hours\*
. 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

Exclusion criteria

. Do-Not-Resuscitate status

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This study seems to measure both the child who was in the PICU and their siblings — can you help me understand which parts of the study my family would be asked to participate in, and what that would actually look like for us day to day?
2The trial is tracking physical recovery using things like a hand-grip strength test and a 6-minute walk test — given where my child is right now in their recovery, do you think they'd be able to meaningfully participate in those kinds of assessments?
3Since this study doesn't have a treatment phase and seems focused on observing and measuring outcomes after a PICU stay, does that mean there's no experimental therapy involved, and would participating change anything about my child's actual medical care?
4The study is also measuring the emotional wellbeing and coping of siblings using questionnaires and interviews — is there any risk that participating in those conversations could be distressing for my other children, and how is that handled?
5Given that this trial is focused on understanding Post Intensive Care Syndrome in children, do you think the follow-up assessments they're doing would give us useful information about my child's recovery that we wouldn't otherwise get through standard care?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

[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

[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

[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

[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

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

Timeframe: 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]

Timeframe: 6- and 18-month post-PICU discharge

Trial details

NCT IDNCT06812130

SponsorKK Women's and Children's Hospital

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2027-06

Contact for this trial

Eric Jia Yong Ong, BSc (Hons)

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

View on ClinicalTrials.gov More Post Intensive Care Syndrome (PICS) trials