UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057222 |
|---|---|
| Receipt number | R000065410 |
| Scientific Title | A Prospective Observational Study on the Long-Term Prognosis of Children with Asymptomatic Congenital Cytomegalovirus Infection |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/03/06 12:02:55 |
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Basic information
Public title
A Study on the Long-Term Prognosis of Children with Asymptomatic Congenital Cytomegalovirus Infection
Acronym
A Study on Children with Asymptomatic Congenital Cytomegalovirus Infection
Scientific Title
A Prospective Observational Study on the Long-Term Prognosis of Children with Asymptomatic Congenital Cytomegalovirus Infection
Scientific Title:Acronym
A Study on Asymptomatic Congenital Cytomegalovirus Infection
Region
| Japan |
Condition
Condition
congenital cytomegalovirus infection
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The Prevalence of Developmental Delays and Developmental Disorders
Basic objectives2
Others
Basic objectives -Others
Wechsler Intelligence scale for children
Modified Checklist for Autism in Toddlers
Strength and Difficulties Questionnaire
Social Communication Questionnaire
Attention-Deficit Hyperactivity Disorder Rating Scale
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Wechsler Intelligence scale for children (WISC)
Key secondary outcomes
Modified Checklist for Autism in Toddlers
Strength and Difficulties Questionnaire
Social Communication Questionnaire
Attention-Deficit/Hyperactivity Disorder Rating Scale
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
| 1 | days-old | <= |
Age-upper limit
| 7 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children diagnosed with congenital cytomegalovirus infection at Nagoya University Hospital and affiliated research institutions, who are asymptomatic.
Key exclusion criteria
Individuals with chromosomal abnormalities or other congenital or organic diseases.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Torii |
Organization
Nagoya University Hospital
Division name
pediatrics
Zip code
4668550
Address
65 tsurumai-cho showa-ku nagoya-city Aichi
TEL
0527442294
yuka.torii.c0@f.mail.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Torii |
Organization
Nagoya University Hospital
Division name
Pediatrics
Zip code
4668550
Address
65 tsurumai-cho showa-ku nagoya-city Aichi
TEL
0527442294
Homepage URL
yuka.torii.c0@f.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
nagoya university hospital
Address
65 Tsurumai-cho Showa-ku Nagoya-city Aichi
Tel
0527442294
torii.yuka.c0@f.mail.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
| 2025 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2036 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cases diagnosed with asymptomatic congenital cytomegalovirus infection at participating research facilities between April 1, 2025, and March 31, 2029.
Measurement Items:
Intelligence test (WISC)
Modified Checklist for Autism in Toddlers, Revised (M-CHAT)
Strengths and Difficulties Questionnaire (SDQ)
Social Communication Questionnaire (SCQ) for assessing symptoms related to Autism Spectrum Disorder (ASD)
ADHD Rating Scale (ADHD-RS) for diagnosis and assessment
Management information
Registered date
| 2025 | Year | 03 | Month | 06 | Day |
Last modified on
| 2025 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065410
