UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study for efficacy of usage of enteral nutrient with immuno-balance modulation action in perioperative management of pediatric patients
Title of the study (Brief title)	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	Kouji Masumoto
Organization	University of Tsukuba Hospital
Division name	Department of Pediatric Surgery, Faculty of Medicine
Address	Tennoudai 1-1-1, Tsukuba, Ibaraki, JAPAN
TEL	029-853-3094
Email	kmasu@md.tsukuba.ac.jp

Public contact
Name of contact person	Kouji Masumoto
Organization	University of Tsukuba Hospital
Division name	Department of Pediatric Surgery, Faculty of Medicine
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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