NCT06812130 Surviving the Pediatric Intensive Care Unit (PICU)
| NCT ID | NCT06812130 |
| Status | Recruiting |
| Phase | — |
| Sponsor | KK Women's and Children's Hospital |
| Condition | Post Intensive Care Syndrome (PICS) |
| Study Type | OBSERVATIONAL |
| Enrollment | 404 participants |
| Start Date | 2025-02-11 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 404 participants in total. It began in 2025-02-11 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
A/Prof Lee Jan Hau, MBBS, MRCPCH, MCI
PRINCIPAL INVESTIGATOR
KK Women's and Children's Hospital
Frequently Asked Questions
Who can join the NCT06812130 clinical trial?
This trial is open to participants of all sexes, aged 28 Days or older, up to 16 Years, studying Post Intensive Care Syndrome (PICS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06812130 currently recruiting?
Yes, NCT06812130 is actively recruiting participants. Contact the research team at eric.ong.j.y@kkh.com.sg for enrollment information.
Where is the NCT06812130 trial being conducted?
This trial is being conducted at Singapore, Singapore, Singapore, Singapore.
Who is sponsoring the NCT06812130 clinical trial?
NCT06812130 is sponsored by KK Women's and Children's Hospital. The principal investigator is A/Prof Lee Jan Hau, MBBS, MRCPCH, MCI at KK Women's and Children's Hospital. The trial plans to enroll 404 participants.