UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052602 |
|---|---|
| Receipt number | R000058608 |
| Scientific Title | Observational study about natural history of acute gastroenteritis in children |
| Date of disclosure of the study information | 2023/10/25 |
| Last modified on | 2024/11/06 19:08:19 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Observational study about natural history of acute gastroenteritis in children
Acronym
Observational study about natural history of acute gastroenteritis in children
Scientific Title
Observational study about natural history of acute gastroenteritis in children
Scientific Title:Acronym
Observational study about natural history of acute gastroenteritis in children
Region
| Japan |
Condition
Condition
acute gastroenteritis
Classification by specialty
| Gastroenterology | Infectious disease | Pediatrics |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Describe the epidemiological characteristics of the natural history of acute gastroenteritis in children
Basic objectives2
Others
Basic objectives -Others
the epidemiological characteristics of the natural history of acute gastroenteritis in children
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of cases with resolution of vomiting by 4 hours after medical examination
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
| 6 | months-old | <= |
Age-upper limit
| 15 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Clinically diagnosed acute gastroenteritis
More than two episode of vomiting within 24 hours of the reception time.
More than one episode of vomiting within 4 hours of the reception time.
6 months and 15 years of age
Key exclusion criteria
Bilious or bloody vomiting is present
impaired consciousness.
Severe dehydration or hypoglycemia requiring rapid infusion
Receiving antiemetic medication within 72 hours prior to registration
Weighing less than 8 kg at the time of examination
Acknowledging underlying disease
A history of abdominal surgery
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Shun |
| Middle name | |
| Last name | Kishibe |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Emergency and critical care department
Zip code
183-8561
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL
0423005111
jemstone625@gmail.com
Public contact
Name of contact person
| 1st name | Shun |
| Middle name | |
| Last name | Kishibe |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Emergency and critical care department
Zip code
183-8561
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL
0423005111
Homepage URL
jemstone625@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Children's Medical Center
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Children's Medical Center
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo
Tel
0423005111
jemstone625@gmail.com
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
| 2023 | Year | 10 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2023 | Year | 10 | Month | 25 | Day |
Last modified on
| 2024 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058608
