Surviving the Pediatric Intensive Care Unit (PICU)
ConditionPost Intensive Care Syndrome (PICS)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age28-16
SponsorKK Women's and Children's Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Do-Not-Resuscitate status
Lack of informed consent
Prior enrolment in this study
Children of critically ill sibling with Do-Not-Resuscitate status
Trial population
\[HOPE Cohort\] Paediatric patients, aged 28 days - 16 years of age, admitted to either PICU at KK Women's and Children's Hospital, Singapore or National University Hospital, Singapore. \[SHACK-S Cohort\] Siblings, aged 4 - 16 years old, of paediatric patients admitted to either PICU at KK Women's and Children's Hospital, Singapore or National University Hospital, Singapore.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
This is a non-interventional study.
Other interventionThis is a non-interventional study.
Treatment groups
404 Participants
are divided into 2 treatment groupsGroup A: HOPE Cohort (PICU Survivors)1 intervention
Group B: SHACK-S Cohort (Siblings of PICU Survivors)1 intervention
Trial outcomes
Primary outcomes
1
[HOPE] Pediatric Evaluation of Disability Inventory (PEDI-CAT) [Physical health outcomes of PICU survivors]
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 discharge2
[HOPE] Functional Status Scale (FSS) [Physical health outcomes of PICU survivors]
Measures 6 domains of functioning: Mental Status, Sensory, Communication, Motor Function, Feeding, Respiratory
Time frame
Baseline, Hospital Discharge (up to 18 months post-PICU discharge), 6-, 12- and 18-month post-PICU discharge3
[HOPE] Hand-grip strength test [Physical health outcomes of PICU survivors]
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 discharge4
[HOPE] 6-minute walk test [Physical health outcomes of PICU survivors]
Assessment of aerobic capacity and endurance (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 dischargeSecondary outcomes
1
[HOPE] PedsQL 1.0 Infant Scales [Overall Family Health]
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 discharge2
[HOPE] PedsQL 4.0 Short Form 15 (SF15) [Overall Family Health]
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 discharge3
[HOPE] PedsQL 3.0 Cognitive Functioning Scales [Overall Family Health]
Measures cognitive functioning in paediatric patients (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 discharge4
[HOPE] Young Child PTSD Screen / Child and Adolescent PTSD Screen [Overall Family Health]
Brief screening for PTSD symptoms (Children)
Time frame
6-, 12- and 18-month post-PICU dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
KK Women's and Children's Hospital
Lead sponsor
National University Hospital, Singapore
Collaborator
Duke-NUS Graduate Medical School
Collaborator
Singapore Clinical Research Institute
Collaborator
Source ClinicalTrials.gov