UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053869 |
|---|---|
| Receipt number | R000061489 |
| Scientific Title | Baby Cooling Japan Registry-2 |
| Date of disclosure of the study information | 2024/03/14 |
| Last modified on | 2024/03/14 19:50:35 |
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Basic information
Public title
Baby Cooling Japan Registry-2
Acronym
BCJ-2
Scientific Title
Baby Cooling Japan Registry-2
Scientific Title:Acronym
BCJ-2
Region
| Japan |
Condition
Condition
Hypoxic Ischemic Encephalopathy of Newborn
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe the long-term motor, cognitive, and language development outcomes, as well as neurodevelopmental disorders, in all severity levels of HIE patients, including beyond school age.
Basic objectives2
Others
Basic objectives -Others
To determine whether there is a higher incidence of motor, cognitive, and language development delays, as well as neurodevelopmental disorders, in newborns with mild HIE compared to the general population.
To identify clinical factors and early predictive indicators associated with the health and developmental issues of newborns with HIE.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary composite outcome of death or mild/ moderate/severe NDI will be assessed at 24 months of age. Impairment is defined as any of the following: cerebral palsy with Gross Motor Function Classification System (GMFCS) level1-5, or the development assessed with the 24 month Ages and Stages Questionnaire (ASQ) Japan below threshold defined as a score lower than 2 standard deviations from the mean on any of the five domains, epilepsy, or hearing loss.
Key secondary outcomes
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
| 36 | weeks-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Infants must meet all 3 inclusion criteria
Neonates born at over 36 weeks, birth weight over1800g
1) Perinatal Acidosis based on at least one of the following:
pH less than 7.00 in any cord or first infant gas (arterial, venous, or capillary) within 60 min OR base deficit more than16 in any cord or first infant gas (arterial, venous or capillary) within 60 min
If pH is between 7.01 and 7.15, OR base deficit is between 10 and 15.9 mmol/l, OR blood gas is not available, an acute perinatal event
Apgar score at 10 min less or equal to 5
Continued need for resuscitation at 10 min (chest compressions, bag mask ventilation, or positive pressure ventilation)
2) Mild to severe Encephalopathy on neonatal neurologic exam within 6 hours after birth: defined as presence of at least 2 signs of mild, moderate, or severe encephalopathy.
Key exclusion criteria
Congenital or chromosomal anomaly associated with abnormal neurodevelopment or death
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Shibasaki |
Organization
Kanagawa Children's Medical Center
Division name
Department of Neonatology
Zip code
232-0064
Address
2-138-4 Mutsukawa, Minami-ku, Yokohama, Kanagawa 232-8555, Japan
TEL
0457112351
jshibasaki5352@gmail.com
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Shibasaki |
Organization
Kanagawa Children's Medical Center
Division name
Department of Neonatology
Zip code
232-0064
Address
2-138-4 Mutsukawa, Minami-ku, Yokohama, Kanagawa 232-8555, Japan
TEL
0457112351
Homepage URL
https://babycooling.jp/
jshibasaki5352@gmail.com
Sponsor or person
Institute
Kanagawa Children's Medical Center
Institute
Department
Personal name
Jun Shibasaki
Funding Source
Organization
KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University Graduate School of Medical Sciences
Address
1 Kawasumi, Mizuho, Nagoya, Aichi, 467-8602 Japan
Tel
052-853-8077
irb_jimu@med.nagoya-cu.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 | 03 | Month | 14 | Day |
Related information
URL releasing protocol
https://babycooling.jp/
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 | 17 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2039 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Obsevational study
Management information
Registered date
| 2024 | Year | 03 | Month | 14 | Day |
Last modified on
| 2024 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061489
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
