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 2023/12/11 12:14:14

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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

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

052-744-2294

Homepage URL


Email

kidokoro@med.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

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

Up to Dec 11, 2023, we have recorded 253 EEG-fNIRS in 102 patients. Because available data is limited due to machine problems and artefacts, we continue recordings.


Management information

Registered date

2019 Year 12 Month 07 Day

Last modified on

2023 Year 12 Month 11 Day



Link to view the page

Value
https://center6.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