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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name