UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056287 |
|---|---|
| Receipt number | R000064318 |
| 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 | 2024/11/28 10:05:32 |
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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 (WISC)
Modified Checklist for Autism in Toddlers (M-CHAT)
Strength and Difficulties Questionnaire (SDQ)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Wechsler Intelligence scale for children (WISC)
Modified Checklist for Autism in Toddlers (M-CHAT)
Strength and Difficulties Questionnaire (SDQ)
Key secondary outcomes
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
| 6 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with congenital CMV infection confirmed by CMVDNA in urine within 21 days after birth.
Patients without the following condition: Abnormal head imaging findings, Chorioretinitis, Abnormal auditory brainstem response.
Patients within 6 months of age at the time of obtaining consent.
Patients who are born at 34 weeks of age or later.
Patients whose legal representatives have been provided with sufficient explanation of the study and have given written consent for participation.
Key exclusion criteria
In the Presence of Other Comorbidities
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
torii.yuka.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
torii.yuka.c0@f.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
KAKENHI
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
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 | 02 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2035 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To Observe the Developmental Outcomes of Children with Asymptomatic Congenital CMV Infection
Management information
Registered date
| 2024 | Year | 11 | Month | 28 | Day |
Last modified on
| 2024 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064318
