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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023841
Receipt No. R000027358
Scientific Title Analysis of the perinatal biochemichal and physiological factors associated with long-term neurodevelopmental outcomes in monochorionic twins
Date of disclosure of the study information 2016/09/01
Last modified on 2019/09/04

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Basic information
Public title Analysis of the perinatal biochemichal and physiological factors associated with long-term neurodevelopmental outcomes in monochorionic twins
Acronym Monochorionic twins Developmental Outcome Study(MonDO Study)
Scientific Title Analysis of the perinatal biochemichal and physiological factors associated with long-term neurodevelopmental outcomes in monochorionic twins
Scientific Title:Acronym Monochorionic twins Developmental Outcome Study(MonDO Study)
Region
Japan

Condition
Condition monochorionic twins
Classification by specialty
Obsterics and gynecology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To analyze the perinatal biochemical and physiological factors associated with long-term neurodevelopmental outcomes in monochorionic twins
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Predictive factors of death or morbidity of severe neurological sequelae(cerebral palsy,blindness and hearing loss) at 18 and 36 months of age
Key secondary outcomes Factors associated with growth retardation,mild neurodevelopmental delay,epilepsy,cardiac problems and renal problems at 18 and 36 months of age

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
3 years-old >=
Gender Male and Female
Key inclusion criteria MD twin infants and children whose mothers received antenatal care at Toho University Ohmori Medical Center

Agree to participate in the study
Key exclusion criteria Not agree to participate in the study

Those that the reserchers were considered inappropriate
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hitoshi
Middle name
Last name Yoda
Organization Toho University Ohmori Medical Center
Division name Neonatology
Zip code 143-8541
Address 6-11-1,Ohmori-Nishi,Ohta-ku,Tokyo 143-8541,Japan
TEL 03-3762-4151
Email yoda@med.toho-u.ac.jp

Public contact
Name of contact person
1st name Hiroko
Middle name
Last name Arai
Organization Toho University Ohmori Medical Center
Division name Neonatology
Zip code 143-8541
Address 6-11-1,Ohmori-Nishi,Ohta-ku,Tokyo 143-8541,Japan
TEL 03-3762-4151
Homepage URL
Email araihiro@med.toho-u.ac.jp

Sponsor
Institute Toho University Ohmori Medical Center
Institute
Department

Funding Source
Organization Ministry of Education,Culture,Sports,Science and Tecnology of Japan
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 Toho University Omori Medical Center
Address 6-11-1,Omori-Nishi,Ota-ku,Tokyo,
Tel 03-3762-4151
Email somu.omori@jim.toho-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
2016 Year 09 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
2016 Year 07 Month 29 Day
Date of IRB
2016 Year 07 Month 13 Day
Anticipated trial start date
2016 Year 08 Month 01 Day
Last follow-up date
2022 Year 09 Month 30 Day
Date of closure to data entry
2022 Year 09 Month 30 Day
Date trial data considered complete
2022 Year 09 Month 30 Day
Date analysis concluded
2023 Year 03 Month 31 Day

Other
Other related information In outborn cases,we will ask for survey of MD twin's outcome.

Management information
Registered date
2016 Year 08 Month 30 Day
Last modified on
2019 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027358

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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