Surviving the Pediatric Intensive Care Unit (PICU)

KK Women's and Children's Hospital

Status: Enrolling

Conditions: Post Intensive Care Syndrome (PICS)

Treatments: Other: This is a non-interventional study.

Study type: Observational

Funder types: Other

Identifiers

NCT06812130

ECOS Ref: 2024-3978

Details and patient eligibility

About

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.

Full 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.

Enrollment: 404 estimated patients

Sex: All

Ages: 28 days to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

404 participants in 2 patient groups

HOPE Cohort (PICU Survivors)

Description:

Helping to Optimize Patients' Experiences (HOPE) after Pediatric Critical Illness Cohort Study \[Sample Size: 240 participants\]

Treatment:

Other: This is a non-interventional study.

SHACK-S Cohort (Siblings of PICU Survivors)

Description:

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. \[Sample Size (Quantitative): 164 participants; Sample Size (Qualitative): 20 participants\]

Treatment:

Other: This is a non-interventional study.