UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004636 |
|---|---|
| Receipt number | R000005531 |
| Scientific Title | Development of a dehydration score for children of acute gastroenteritis |
| Date of disclosure of the study information | 2010/12/01 |
| Last modified on | 2016/07/22 17:52:59 |
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Basic information
Public title
Development of a dehydration score for children of acute gastroenteritis
Acronym
Development of a dehydration score for children of acute gastroenteritis
Scientific Title
Development of a dehydration score for children of acute gastroenteritis
Scientific Title:Acronym
Development of a dehydration score for children of acute gastroenteritis
Region
| Japan |
Condition
Condition
Acute gastroenteritis
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a more useful dehydration score based on the existing score
To assess the effectiveness of the items from American Academy of Pediatrics dehydration score or other dehydration score in relation to weight change from pre-to post-rehydration
Basic objectives2
Others
Basic objectives -Others
Clinical dehydration scale
weight change from pre-to post-rehydration
capillary refill time
Turgor
respiratory pattern
fever,vomiting,diarrhea,ingestion,urination
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical dehydration scale
weight change from pre-to post-rehydration
capillary refill time
Turgor
respiratory pattern
fever,vomiting,diarrhea,ingestion,urination
Key secondary outcomes
Assessments of Dehydration codified by the American Academy of Pediatrics,Center for Disease Control and so on
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 | months-old | <= |
Age-upper limit
| 72 | months-old | > |
Gender
Male and Female
Key inclusion criteria
1.clinically diagnosed as acute
gastroenteritis
2.one month to six years old
3.hospitalization is necessary for
treatment
Key exclusion criteria
1.a chronic disease
(cardiovascular disease,
renal disease, malignancy,
endocrine disease, metabolic disease,
immune deficiency disease,
chromosomal disorder,
neuromuscular disease)
2.history of inappropriate low body weight and malnutrition
3.symptoms over eight days
4.hyponatremia(Na<130 mEq/l)
hypernatremia(Na>150 mEq/l)
hypoglycemia(BS<50 mg/dl)
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukihiro Hasegawa |
Organization
Tokyo Metropolitan Children's medical center
Division name
general pediatrics
Zip code
Address
2-8-29 Musashidai Fuchu-shi Tokyo
TEL
042-300-5111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokyo Metropolitan Children's medical center
Division name
general pediatrics
Zip code
Address
2-8-29 Musashidai Fuchu-shi Tokyo
TEL
042-300-5111
Homepage URL
Sponsor or person
Institute
Tokyo Metropolitan Children's medical center
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
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
東京都立小児総合医療センター Tokyo Metropolitan Children's medical center
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2010 | Year | 11 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
prospective study
complete survey
the correlation of physiological findings of dehydration with weight change
Management information
Registered date
| 2010 | Year | 11 | Month | 30 | Day |
Last modified on
| 2016 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005531
