A Study on the Current State of Emergency Critical Care for Critically Ill Children and Their Long-term Outcomes

UMIN ID: UMIN000054677

Registered date:18/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients aged 1 month to under 16 years at ICU admission. Patients who stayed in the intensive care unit (ICU) for more than 48 hours.
• Date of first enrollment: 2024/05/17
• Target sample size: 800
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Six months after ICU discharge: Changes in Functional Status Score (FSS) of 3 or higher
• Secondary Outcome: 1) ICU discharge Survival rate, Functional Status Score (FSS), Pediatric Cerebral Performance Category Scale (PCPC), Duration of mechanical ventilation, Length of ICU stay or hospital stay, Total hospitalization costs, Rate of discharge to home, Provision of medical care at home 2) 3 and 6 months after ICU discharge Children: Survival rate, Functional Status Score(FSS), Pediatric Cerebral Performance Category Scale(PCPC), Pediatric Symptom Checklist(J-PSL 17), rate of return to home or school, Provision of medical care at home, Incidence of re-admission or emergency department visits Family Members or Caregivers: Background information (relationship with the child, age, occupation, family situation, etc), Post-traumatic Stress Disorder Checklist Specific(PCL-S), Measure of Processes of Care (MPOC-20)

Key inclusion & exclusion criteria

• Age minimum: 1months-old
• Age maximum: 16years-old
• Gender: Male and Female
• Exclude criteria: 01) Previously included patients in this study 02) Patients with underlying conditions or receiving medical care before ICU admission (PCPC of 2 or higher, or FSS of 7 or higher) 03) Patients who died during ICU admission 04) Patients transferred to the other medical institution for treatment or management purposes after ICU admission 05) Patients transferred to the ICU after more than 14 days of ward admission management 06) Patients transferred from a previous hospital after more than 14 days of ICU management and then transferred 07) Patients scheduled for admission for diagnostic tests or monitoring 08) Patients scheduled for admission for perioperative management of planned surgeries 09) Patients for whom consent for research cooperation could not be obtained from a proxy 10) Patients whose proxies do not have electronic devices capable of responding to online surveys 11) Other patients deemed ineligible for participation in this study by the research personnel

Related Information

• Primary Sponsor: Department of Emergency, Critical Care and Disaster Medicine Faculty of Medicine, Dentistry and Pharmaceutical Sciences
• Source(s) of Monetary Support: Japan Foundation for pediatric research Kobayashi Aoitori Foundation