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

Long-term outcomes of acutely and critically ill children and their families in Japan - J-RANDCEL study: Long-teRm outcomes of Acutely aND critically ill Children and thEir famiLies in Japan

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000054677
Enrollment
800
Registered
2024-06-18
Start date
2024-05-17
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

None listed

Sponsors

Department of Emergency, Critical Care and Disaster Medicine Faculty of Medicine, Dentistry and Pharmaceutical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who stayed in the Intensive Care Unit: ICU for more than 48 hours (Intensive Care Unit is defined as a facility that applies either the Emergency Critical Care Admission Fee, Specific Intensive Care Unit Surcharge, or Pediatric Specific Intensive Care Management Surcharge)

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Six months after ICU discharge: Changes in Functional Status Score (FSS) of 3 or higher

Secondary

MeasureTime frame
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)

Countries

Japan

Contacts

Public ContactTakafumi Obara

Faculty of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University Department of Emergency, Critical Care and Disaster Medicine

tkfmobr16@okayama-u.ac.jp086-235-7426

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026