This is a non-interventional study.
OtherThis is a non-interventional study.
NCT Number: NCT06812130
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.
Interested in participating?
Request Info28 day–16 year
All sexes
Observational
KK Women's and Children's Hospital, Singapore
The objectives of Helping to Optimize Patients' Experiences (HOPE) after Pediatric Critical Illness Cohort Study are:
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
[HOPE Cohort]
[SHACK-S Cohort]
Exclusion criteria
[HOPE Cohort]
[SHACK-S Cohort]
This is a non-interventional study.
Time frame: Baseline, Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge
Measures functional domains: Daily Activities, Mobility, Social/Cognitive and Responsibility
Time frame: Baseline, Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge
Measures 6 domains of functioning: Mental Status, Sensory, Communication, Motor Function, Feeding, Respiratory
Time frame: Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge
Measures of maximum voluntary muscle strength (Only for study participants aged 6 years old and above)
Time frame: Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge
Assessment of aerobic capacity and endurance (Only for study participants aged 6 years old and above)
Time frame: Baseline, 6-, 12- and 18-month post-PICU discharge
Measures developmental domains: Physical, Adaptive Behaviour, Social-Emotional, Cognitive and Communiation
Time frame: 6- and 18-month post-PICU discharge
Measures developmental domains: Cognitive and Language (Only for study participants aged below 3 years old)
Time frame: Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge
Measures cognitive health (Only for study participants aged 3 years old and above)
Time frame: Baseline, 6-, 12- and 18-month post-PICU discharge
Screening tool for behavioural and emotional problems (Only for study participants aged 2 years old and above)
Time frame: PICU discharge, 1-, 3-, and 6-month post-PICU discharge
Measures generic health-related quality of life in children
Time frame: 1-, 3-, and 6-month post-PICU discharge
Screening tool for behavioural and emotional problems
Time frame: 1-, 3-, and 6-month post-PICU discharge
Measures of social and emotional health and resilience, and screening for behavioural concerns (For siblings ages 4-5 years old)
Time frame: 1-, 3-, and 6-month post-PICU discharge
Measure of cogntive and behavioural coping in children and adolescents (For siblings ages 6-18 years old)
Time frame: 3- and 6-month post-PICU discharge
To understand experiences and support needs of siblings of critically ill children
Time frame: Baseline, Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge
Measure generic health-related quality of life in infants (Only for study participants aged below 2 years old)
Time frame: Baseline, Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge
Measure generic health-related quality of life in children (Only for study participants aged 2 - 16 years old)
Time frame: Baseline, Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge
Measures cognitive functioning in paediatric patients (Only for study participants aged 2 - 16 years old)
Time frame: 6-, 12- and 18-month post-PICU discharge
Brief screening for PTSD symptoms (Children)
Time frame: Baseline, Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge
Measures the impact of pediatric chronic health conditions on parents and the family
Time frame: PICU discharge, Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge
Brief screener for depression and anxiety (in parent)
Time frame: 6-, 12- and 18-month post-PICU discharge
Parent self-report measure of DSM-5 symptoms of PTSD
Contact information is provided by the study sponsor or research team.
KK Women's and Children's Hospital
Other Gov
Surviving the Pediatric Intensive Care Unit (PICU): Long-term Study to Understand and Improve Outcomes of PICU Survivors and Their Families
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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