UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029606 |
|---|---|
| Receipt number | 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 | 2021/04/21 11:52:27 |
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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
| 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
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
katsuorobi@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University Koto Toyosu Hospital
Department of Pediatrics
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030619
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
