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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000009323
Receipt No. R000010948
Scientific Title Efficacy of an enteral feeding protocol on nutritional support after pediatric cardiac surgery.
Date of disclosure of the study information 2012/11/12
Last modified on 2018/05/20

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Basic information
Public title Efficacy of an enteral feeding protocol on nutritional support after pediatric cardiac surgery.
Acronym Efficacy of an enteral feeding protocol on nutritional support after pediatric cardiac surgery.
Scientific Title Efficacy of an enteral feeding protocol on nutritional support after pediatric cardiac surgery.
Scientific Title:Acronym Efficacy of an enteral feeding protocol on nutritional support after pediatric cardiac surgery.
Region
Japan

Condition
Condition pediatric cardiovascular surgery
Classification by specialty
Pediatrics Cardiovascular surgery Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 the safety and improvement of nutrition support with an enteral feeding protocol
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the time taken to initiate nutrition support, the proportion of the estimated average requirement
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 nutrition support with an enteral feeding protocol after pediatric cardiovascular surgery
Interventions/Control_2 without an enteral feeding protocol
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
120 months-old >
Gender Male and Female
Key inclusion criteria children after cardiovascular surgery in intensive care unit
Key exclusion criteria patients with endocrine disease,disorder of metabolism, heart failure, hypothermia management, bowel ischemia or gastrointestinal bleeding
Target sample size 60

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Shinichiro Yoshimura
Organization Nagoya City University
Division name Department of Anesthesiology and Medical Crisis Management
Zip code
Address 1-Kawasumi, Mizuho-cho Mizuho-ku, Nagoya 467-8601, JAPAN
TEL 09045874090
Email s.yoshimura0829@gmail.com

Public contact
1st name of contact person
1st name
Middle name
Last name Shinichiro Yoshimura
Organization Nagoya City University
Division name Department of Anesthesiology and Medical Crisis Management
Zip code
Address 1-Kawasumi, Mizuho-cho Mizuho-ku, Nagoya 467-8601, JAPAN
TEL 09045874090
Homepage URL
Email s.yoshimura0829@gmail.com

Sponsor
Institute Department of Anesthesiology and Medical Crisis Management, Nagoya City University
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

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 12 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.aaic.net.au/document/?D=20140621
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 Main results already published
Date of protocol fixation
2012 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 13 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
2012 Year 11 Month 12 Day
Last modified on
2018 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010948

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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