Understanding long-term effects of pediatric intensive care on patients and their siblings

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

This study looks at the long-term health and quality of life for children who have survived a stay in the pediatric intensive care unit and their healthy siblings to see how critical illness affects them and their families.

Quick facts

• Study type: Observational
• Enrollment: 404 (estimated)
• Ages: 28 Days to 16 Years
• Sex: All
• Sponsor: KK Women's and Children's Hospital (other gov)
• Locations: 2 sites (Singapore, Singapore and 1 other locations)
• Trial ID: NCT06812130 on ClinicalTrials.gov

What this trial studies

This observational study aims to characterize the long-term physical and cognitive health outcomes of children who survive a stay in the pediatric intensive care unit (PICU). It includes two cohorts: one focusing on PICU survivors and the other on their healthy siblings, assessing their quality of life and support needs after the critically ill child's discharge. The study will investigate risk factors associated with poor health outcomes in PICU survivors and explore the broader impact of critical illness on family dynamics. By emphasizing patient-reported outcomes, the research seeks to identify challenges and solutions for improving survivorship experiences.

Who should consider this trial

Good fit: Ideal candidates include children aged 28 days to 16 years who are expected to stay in the PICU for more than 48 hours.

Not a fit: Patients with Do-Not-Resuscitate status or those with complex chronic conditions or neurodevelopmental delays may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved support and interventions for pediatric PICU survivors and their families, enhancing their long-term health and quality of life.

How similar studies have performed: While the concept of post-intensive care syndrome in pediatrics is gaining recognition, this specific approach to studying both survivors and their siblings is relatively novel and has not been extensively tested.

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.

Where this trial is running

Singapore, Singapore and 1 other locations

• National University Singapore — Singapore, Singapore, Singapore (RECRUITING)
• KK Women's and Children's Hospital — Singapore, Singapore, Singapore (RECRUITING)

Study contacts

• Principal investigator: A/Prof Lee Jan Hau, MBBS, MRCPCH, MCI — KK Women's and Children's Hospital
• Study coordinator: Eric Jia Yong Ong, BSc (Hons)

Conditions: Post Intensive Care Syndrome, PICS-p, Prospective Observational Cohort Study, Post Intensive Care Syndrome in Paediatrics