UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061307 |
|---|---|
| Receipt number | R000069474 |
| Scientific Title | A Nationwide Study on Severe Respiratory Syncytial Virus Infection in Children with Pulmonary Hypoplasia, Airway Stenosis, Esophageal Atresia, Inborn Errors of Metabolism, and Neuromuscular Diseases |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/04/19 07:09:54 |
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Basic information
Public title
A Nationwide Study on Severe Respiratory Syncytial Virus Infection in Children with Pulmonary Hypoplasia, Airway Stenosis, Esophageal Atresia, Inborn Errors of Metabolism, and Neuromuscular Diseases
Acronym
A Nationwide Survey of Respiratory Syncytial Virus Infection in Five Newly Approved Indication Disease Groups
Scientific Title
A Nationwide Study on Severe Respiratory Syncytial Virus Infection in Children with Pulmonary Hypoplasia, Airway Stenosis, Esophageal Atresia, Inborn Errors of Metabolism, and Neuromuscular Diseases
Scientific Title:Acronym
A Nationwide Survey of Respiratory Syncytial Virus Infection in Five Newly Approved Indication Disease Groups
Region
| Japan |
Condition
Condition
Pulmonary Hypoplasia, Airway Stenosis, Esophageal Atresia, Inborn Errors of Metabolism, and Neuromuscular Diseases
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate changes in the rate of hospitalization and severity of respiratory syncytial virus (RSV) infection among children under 5 years of age with five disease groups (pulmonary hypoplasia, airway stenosis, esophageal atresia, inborn errors of metabolism, and neuromuscular diseases) newly approved for palivizumab prophylaxis in April 2024.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Proportion of hospitalizations due to RSV infection among the five target disease groups before and after the indication expansion
Before indication expansion: April 2022 to March 2024
After indication expansion: April 2024 to March 2026
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
| 1 | days-old | <= |
Age-upper limit
| 5 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Children who have medical records from April 2022 to March 2026 and were between 0 and 5 years old at any point during that period, and who have one of the following five categories of diseases: pulmonary hypoplasia, airway stenosis, congenital esophageal atresia, congenital metabolic disorders, and neuromuscular diseases.
Key exclusion criteria
Children aged 5 years or older with any of the following five categories of diseases: pulmonary hypoplasia, airway stenosis, congenital esophageal atresia, congenital metabolic disorders, and neuromuscular diseases.
Target sample size
2100
Research contact person
Name of lead principal investigator
| 1st name | Masaaki |
| Middle name | |
| Last name | Mori |
Organization
Institute of Science Tokyo
Division name
Departnment of Lifelong Immunotherapy
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
+81-3-5803-4677
mori.phv@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Masaaki |
| Middle name | |
| Last name | Mori |
Organization
Institute of Science Tokyo
Division name
Departnment of Lifelong Immunotherapy
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
+81-3-5803-4677
Homepage URL
mori.phv@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Institute of Science Tokyo
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
Institute of Science Tokyo
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
+81-3-5803-4876
mori.phv@tmd.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
| 2026 | Year | 06 | 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
| 2026 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Information on the target patients will be collected retrospectively from medical records for a specified period. The observation and survey items are as follows. A survey will be conducted in a questionnaire format using Microsoft Forms.
Management information
Registered date
| 2026 | Year | 04 | Month | 19 | Day |
Last modified on
| 2026 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069474
