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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030236
Receipt No. R000034377
Scientific Title temporal observation of fine retinal structure in children
Date of disclosure of the study information 2017/12/04
Last modified on 2017/12/03

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Basic information
Public title temporal observation of fine retinal structure in children
Acronym temporal observation of fine retinal structure in children
Scientific Title temporal observation of fine retinal structure in children
Scientific Title:Acronym temporal observation of fine retinal structure in children
Region
Japan

Condition
Condition prematurity
Classification by specialty
Ophthalmology Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 observation of retinal maturation process with OCT to clarify the formation of the macula
Basic objectives2 Others
Basic objectives -Others We will measure vessel density, vessel diameter, and area of foveal avascular zone using OCT angiography.
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes vessel density
vessel diameter
area of foveal avascular zone
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Retinal angiography by OCT after fundus examination is performed until the fundus examination is unnecessary at about once a week during NICU hospitalization.
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

Not applicable
Age-upper limit
0 years-old >=
Gender Male and Female
Key inclusion criteria All infants who need for fundus examination is necessary during NICU hospitalization
Key exclusion criteria Infants judged inappropriate by a neonatologist
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norie Nonobe
Organization Nagoya University Hospital
Division name Maternity & Perinatal Care Center
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL 052-744-2275
Email nonobe@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Norie Nonobe
Organization Nagoya University Hospital
Division name Maternity & Perinatal Care Center
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL 052-744-2275
Homepage URL
Email nonobe@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 04 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 Preinitiation
Date of protocol fixation
2017 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 03 Day
Last modified on
2017 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034377

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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