UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of a dehydration score for children of acute gastroenteritis
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Yukihiro Hasegawa
Organization	Tokyo Metropolitan Children's medical center
Division name	general pediatrics
Address	2-8-29 Musashidai Fuchu-shi Tokyo
TEL	042-300-5111
Email

Public contact
Name of contact person
Organization	Tokyo Metropolitan Children's medical center
Division name	general pediatrics
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 11 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000005531