UMIN-CTR Clinical Trial

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	1 days-old <=
Age-upper limit	7 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 Katsumi Middle name Last name Mizuno
Organization	Showa University School of Medicine
Division name	Department of Pediatrics
Zip code	142-8666
Address	1-5-8 Hatanodai Shinagawa-ku, Tokyo
TEL	03-6204-6000
Email	katsuorobi@med.showa-u.ac.jp

Public contact
Name of contact person	1st name Katsumi Middle name Last name Mizuno
Organization	Showa University Koto Toyosu Hospital
Division name	Department of Pediatrics
Zip code	142-8666
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	Showa University Koto Toyosu Hospital
Address	5-1-38 Toyosu Koto-ku, Tokyo
Tel	0362046000
Email	katsuorobi@med.showa-u.ac.jp

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	https://jhmba.or.jp/detail_2.php
Publication of results	Unpublished

Result
URL related to results and publications	N/A
Number of participants that the trial has enrolled	15
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	There were not many infants who cleared the entry criteria. Besides that we could not have enough time to obtain parenteral consent due to restricted time in COVID-19 pandemic situation.
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	2021 Year 04 Month 21 Day

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