UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000027358