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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029606
Receipt No. R000030619
Scientific Title The effects of standardized nutrition on prognosis of very low-birth-weight infants.
Date of disclosure of the study information 2017/10/20
Last modified on 2017/10/18

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Basic information
Public title The effects of standardized nutrition on prognosis of very low-birth-weight infants.
Acronym standardized nutrition for VLBW infants
Scientific Title The effects of standardized nutrition on prognosis of very low-birth-weight infants.
Scientific Title:Acronym standardized nutrition for VLBW infants
Region
Japan

Condition
Condition very low birth weight infants
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this multicenter randomized control trial is examine the hypothesis that, compared with very preterm infants (<1500g or <28weeks of gestation) receiving standard enteral nutrition which requires waiting for OMM, those receiving DM within 24h of life, have better growth outcomes later in life . Our secondary hypothesis is that those in the intervention arm will have lower medical costs.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes duration of parenteral nutrition
Key secondary outcomes 1.days for establishment of enteral nutrition
2.anthropometric data:maximum weight loss, age(days) of returing to weight gain, weight Z score at discharge fron NICU, incidence of EUGR
3.blood tests: NH3, BUN, RBP, prealbumin, corrected BUN
4.complications: necrotizing enterocolitis, chronic lung disease, retinopathy of prematurity, infections, PN associated cholestasis
5.medical expensis for total NICU stay and for parenteral nutrition
6. breastfeeding rate at discharge from NICU

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 intervention :start enteral feeding at twelve hours of age with donor human milk if own mother's milk is not available
Interventions/Control_2 control : start enteral feeding as usual
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
0 days-old <=
Age-upper limit
0 days-old >=
Gender Male and Female
Key inclusion criteria very low birth weight infants
Key exclusion criteria gastrointestinal diseases
respiratory diseases in need of high concentration of oxygen
circulatory failure in need of high dose ofvasopressor
chromosomal abnormality
multiple mulformations
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsumi Mizuno
Organization Showa University Koto Toyosu Hospital
Division name Department of Pediatrics
Zip code
Address 5-1-38 Toyosu, Koto-ku, Tokyo
TEL 03-6204-6000
Email katsuorobi@med.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsumi Mizuno
Organization Showa University Koto Toyosu Hospital
Division name Department of Pediatrics
Zip code
Address 5-1-38 Toyosu, Koto-ku, Tokyo
TEL 03-6204-6000
Homepage URL http://www.jhmba.or.jp
Email katsuorobi@med.showa-u.ac.jp

Sponsor
Institute Showa University Koto Toyosu Hospital
Department of Pediatrics
Institute
Department

Funding Source
Organization Showa University Koto Toyosu Hospital
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Japanese Human Milk Bank Association
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 昭和大学江東豊洲病院(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 20 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
2017 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 01 Day
Last follow-up date
2018 Year 04 Month 30 Day
Date of closure to data entry
2018 Year 07 Month 31 Day
Date trial data considered complete
2018 Year 08 Month 31 Day
Date analysis concluded
2018 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 10 Month 18 Day
Last modified on
2017 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030619

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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