UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013337 |
|---|---|
| Receipt number | R000015567 |
| Scientific Title | Study about the effectiveness of oral rehydration therapy for acute gastroenteritis in children. |
| Date of disclosure of the study information | 2014/03/05 |
| Last modified on | 2014/03/05 12:32:22 |
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Basic information
Public title
Study about the effectiveness of oral rehydration therapy for acute gastroenteritis in children.
Acronym
Study about the effectiveness of oral rehydration therapy for acute gastroenteritis in children.
Scientific Title
Study about the effectiveness of oral rehydration therapy for acute gastroenteritis in children.
Scientific Title:Acronym
Study about the effectiveness of oral rehydration therapy for acute gastroenteritis in children.
Region
| Japan |
Condition
Condition
acute gastroenteritis
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy by comparing a group that could not be performed with the group that performed oral rehydration therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of children having intravenous infusion during ORT.
Key secondary outcomes
1.Period of vomiting and diarrhea
2.Re-consultation rate
3.Admission rate
4.Adverse event rate
5.Effectiveness of antiflatulent and antiemetic
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 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Clinically diagnosed as acute gastroenteritis.
2.One year old to six years old
3.Hospitalization is unnecessary at the initial visit.
Key exclusion criteria
1.Complication of other infectious diseases.
2.Deuteropathy of other infectious diseases.
3.Complication of serious diseases(convulsion,renal failure)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Raigo Masuzawa |
Organization
Saiseikai Yokohamasi Nanbu Hospital
Division name
Pediatrics
Zip code
Address
3-2-10 Kounandai Kounan-ku,Yokohama City,Kanagawa,Japan
TEL
045-832-1111
r.masuzawa@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Raigo Masuzawa |
Organization
Saiseikai Yokohamasi Nanbu Hospital
Division name
Pediatrics
Zip code
Address
3-2-10 Kounandai Kounan-ku,Yokohama City,Kanagawa,Japan
TEL
045-832-1111
Homepage URL
r.masuzawa@hotmail.co.jp
Sponsor or person
Institute
Saiseikai Yokohamasi Nanbu Hospital
Institute
Department
Personal name
Funding Source
Organization
Saiseikai Yokohamasi Nanbu Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Saiseikai Yokohamasi Tobu Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
済生会横浜市南部病院(神奈川県)Saiseikai Yokohamasi Nanbu Hospital
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective study
Management information
Registered date
| 2014 | Year | 03 | Month | 05 | Day |
Last modified on
| 2014 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015567
