UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044336 |
|---|---|
| Receipt number | R000050640 |
| Scientific Title | The research on the effect of pregnancy complications on brain function and structure in term neonates |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2024/05/30 22:38:38 |
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Basic information
Public title
The research on the effect of pregnancy complications on brain function and structure in term neonates
Acronym
Effect of pregnancy complications on brain in term neonates
Scientific Title
The research on the effect of pregnancy complications on brain function and structure in term neonates
Scientific Title:Acronym
Effect of pregnancy complications on brain in term neonates
Region
| Japan |
Condition
Condition
pregnancy complications
Classification by specialty
| Obstetrics and Gynecology | Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the brain structural and functional alterations in the term infants born to mothers with pregnancy complications.
Basic objectives2
Others
Basic objectives -Others
To investigate the brain structural and functional alterations in the term infants born to mothers with pregnancy complications using MR imaging and EEG-NIRS.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The brain structural and functional alterations in the term infants born to mothers with pregnancy complications.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
MR imaging acquisition (1 time during hospitalization)
Interventions/Control_2
EEG-NIRS test (1 time during hospitalization)
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 | days-old | <= |
Age-upper limit
| 4 | weeks-old | >= |
Gender
Male and Female
Key inclusion criteria
Term neonates who are born at Nagoya University hospital.
Key exclusion criteria
Neonates, considered unsuitable for participation in this study by the investigators
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Ushida |
Organization
Nagoya University hospital
Division name
Division of Reproduction and Perinatology, Center for Maternal-Neonatal Care
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2261
u-taka23@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Takafumi |
| Middle name | |
| Last name | Ushida |
Organization
Nagoya University hospital
Division name
Division of Reproduction and Perinatology, Center for Maternal-Neonatal Care
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2261
Homepage URL
u-taka23@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
MEXT
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, Japan
Tel
052-744-2973
ethics@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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 01 | 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
| 2021 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 26 | Day |
Last modified on
| 2024 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050640
