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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004636
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Tokyo Metropolitan Children's medical center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005531

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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