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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024993
Receipt No. R000028747
Scientific Title Study for efficacy of usage of enteral nutrient with immuno-balance modulation action in perioperative management of pediatric patients
Date of disclosure of the study information 2016/12/15
Last modified on 2016/11/25

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Basic information
Public title Study for efficacy of usage of enteral nutrient with immuno-balance modulation action in perioperative management of pediatric patients
Acronym Efficacy in usage of enteral nutrient with immuno-balance modulation action
Scientific Title Study for efficacy of usage of enteral nutrient with immuno-balance modulation action in perioperative management of pediatric patients
Scientific Title:Acronym Efficacy in usage of enteral nutrient with immuno-balance modulation action
Region
Japan

Condition
Condition Hirschsprung's disease, Atresia ani, Congenital biliary dilatation, GERD
Classification by specialty
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will evaluate the effect of MEIN or other enteral nutrients on postoperative inflammatory condition in perioperative nutritional management in pediatric patients with Hirschsprung disease, ano-rectal malformation, biliary dilatation, and gastroesophageal reflux disease . We also evaluate the nutritional status and fecal condition after surgery, the incidence of infectious complications, the number of hospital days and so on.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Change of postoperative inflammatory condition
Key secondary outcomes the nutritional status and fecal condition after surgery, the incidence of infectious complications, the number of hospital days

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 In the control group, the following enteral nutrient will be administered (breast milk or artificial milk for infants, Racol for infants).
Dose and duration: Before surgery, the patient will take enteral nutrients at 60 to 100 kcal / kg per day for 3 days. After the surgery, enteral nutrition will restart within 2 to 3 days after surgery, and continue until 6th postoperative day.
Interventions/Control_2 In contrast, immunomodulatory nutrition is administered in the test group.
Dose and duration: Before surgery, the patient will take enteral nutrients at 60 to 100 kcal / kg per day for 3 days. After the surgery, enteral nutrition will restart within 2 to 3 days after surgery, and continue until 6th postoperative day.

The study period is from December 1, 2016 to March 31, 2018.
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
6 months-old <=
Age-upper limit
48 months-old >
Gender Male and Female
Key inclusion criteria Hirschsprung's disease, Ano-rectal malformation, Congenital biliary dilatation, GERD
Key exclusion criteria Patients whose enteral nutrition is impossible
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kouji Masumoto
Organization University of Tsukuba Hospital
Division name Department of Pediatric Surgery, Faculty of Medicine
Zip code
Address Tennoudai 1-1-1, Tsukuba, Ibaraki, JAPAN
TEL 029-853-3094
Email kmasu@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kouji Masumoto
Organization University of Tsukuba Hospital
Division name Department of Pediatric Surgery, Faculty of Medicine
Zip code
Address Tennoudai 1-1-1, Tsukuba, Ibaraki, JAPAN
TEL 029-853-3094
Homepage URL
Email kmasu@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba Hospital
Institute
Department

Funding Source
Organization MEIJI
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 15 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 Preinitiation
Date of protocol fixation
2016 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 12 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

Management information
Registered date
2016 Year 11 Month 25 Day
Last modified on
2016 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028747

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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