UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023841 |
|---|---|
| Receipt number | 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 11:47:23 |
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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
| Obstetrics 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
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
araihiro@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Ohmori Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.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 |
