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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038819
Receipt No. 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 2020/06/07

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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 052-744-2309
Email kidokoro@med.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 052-744-2309
Homepage URL
Email kidokoro@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

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 052-744-2309
Email 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 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 Enrolling by invitation
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
2025 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

Management information
Registered date
2019 Year 12 Month 07 Day
Last modified on
2020 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044258

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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