UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054677 |
|---|---|
| Receipt number | R000062483 |
| Scientific Title | Long-term outcomes of acutely and critically ill children and their families in Japan |
| Date of disclosure of the study information | 2024/06/18 |
| Last modified on | 2024/06/18 10:23:46 |
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Basic information
Public title
A Study on the Current State of Emergency Critical Care for Critically Ill Children and Their Long-term Outcomes
Acronym
J-RANDCEL study: Long-teRm outcomes of Acutely aND critically ill Children and thEir famiLies in Japan
Scientific Title
Long-term outcomes of acutely and critically ill children and their families in Japan
Scientific Title:Acronym
J-RANDCEL study: Long-teRm outcomes of Acutely aND critically ill Children and thEir famiLies in Japan
Region
| Japan |
Condition
Condition
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.
Classification by specialty
| Pediatrics | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the current state of emergency and intensive care for critically ill children in Japan, including the subsequent conditions of patients and their families.
Basic objectives2
Others
Basic objectives -Others
Long-term outcomes of acutely and critically ill children and their famiLies
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Six months after ICU discharge: Changes in Functional Status Score (FSS) of 3 or higher
Key secondary outcomes
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)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 1 | months-old | <= |
Age-upper limit
| 16 | years-old | > |
Gender
Male and Female
Key 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)
Key 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
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Obara |
Organization
Faculty of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University
Division name
Department of Emergency, Critical Care and Disaster Medicine
Zip code
7008558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL
0862357426
tkfmobr16@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Takafumi |
| Middle name | |
| Last name | Obara |
Organization
Faculty of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University
Division name
Department of Emergency, Critical Care and Disaster Medicine
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-235-7426
Homepage URL
tkfmobr16@okayama-u.ac.jp
Sponsor or person
Institute
Department of Emergency, Critical Care and Disaster Medicine Faculty of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Japan Foundation for pediatric research
Kobayashi Aoitori Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1 Shikatacho, Kitaku, Okayama
Tel
086-235-6938
tkfmobr16@okayama-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a multi-center collaborative research led by Japanese Association for Acute Medicine (a prospective observational study)
Management information
Registered date
| 2024 | Year | 06 | Month | 17 | Day |
Last modified on
| 2024 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062483
