UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038819 |
|---|---|
| Receipt number | R000044258 |
| Scientific Title | Analysis of neonatal brain function using simultaneous EEG-fNIRS |
| Date of disclosure of the study information | 2019/12/09 |
| Last modified on | 2025/06/16 16:10:38 |
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Basic information
Public title
Analysis of neonatal brain function using simultaneous EEG-fNIRS
Acronym
neonatal EEG-fNIRS
Scientific Title
Analysis of neonatal brain function using simultaneous EEG-fNIRS
Scientific Title:Acronym
neonatal EEG-fNIRS
Region
| Japan |
Condition
Condition
neonates including premature babies
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate cortical hemodynamic changes corresponding to unique EEG findings in neonates with simultaneous EEG-fNIRS, and determine EEG-fNIRS specific findings related to poor neurological prognosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EEG-fNIRS specific findings of 28-44 weeks post-menstrual age.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Wearing NIRS equipment at the same time of clinical EEG. During NICU hospitalization, patients are recorded every 2-4 weeks. It takes 20-30 minutes for one recording.
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
| 28 | weeks-old | <= |
Age-upper limit
| 45 | weeks-old | > |
Gender
Male and Female
Key inclusion criteria
Neonates born under 44 weeks post-menstrual age.
Recording available between 28-44 weeks post-menstrual age.
General condition is good enough to wear EEG and NIRS.
With agreement of parents to attend to this study.
Key exclusion criteria
Bad general condition.
Without agreement of parents to attend to this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kidokoro |
Organization
Nagoya University Hospital
Division name
Pediatrics
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2294
kidokoro.hiroyuki.i6@f.mail.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kidokoro |
Organization
Nagoya University Hospital
Division name
Pediatrics
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2294
Homepage URL
kidokoro.hiroyuki.i6@f.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Hospital
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
Tel
052-744-2294
anna14@med.nagoya-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
名古屋大学医学部附属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://doi.org/10.1093/sleep/zsae225
Number of participants that the trial has enrolled
63
Results
The 8-channel average functional connectivity (FC) progressively increased between 31- and 41-weeks postmenstrual age, with steeper rise observing in active sleep compared to quiet sleep. Especially, connections involving the occipital region exhibited significantly higher FC in active sleep than in quiet sleep. Furthermore, a significant negative correlation was found between the 8-channel average FC at term-equivalent age and developmental quotient assessed at 10 months corrected age.
Results date posted
| 2024 | Year | 12 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None.
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Up to June 11, 2024, we have recorded 259 EEG-fNIRS in 105 patients. Since the number of records is considered sufficient for analysis, patient recruitment has ended. We have published the result of the study using some of the data and are currently processing data for further analysis.
Management information
Registered date
| 2019 | Year | 12 | Month | 07 | Day |
Last modified on
| 2025 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044258
