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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002473
Receipt No. R000002399
Scientific Title Study of nutritional supports for reduction of complications in low birth weight infants-examination bathed from lipoprotein metabolism and body composition analysis from birth to 12 months of ages-
Date of disclosure of the study information 2009/09/09
Last modified on 2016/03/09

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Basic information
Public title Study of nutritional supports for reduction of complications in low birth weight infants-examination bathed from lipoprotein metabolism and body composition analysis from birth to 12 months of ages-
Acronym Study of nutritional support for low birth weight infants
Scientific Title Study of nutritional supports for reduction of complications in low birth weight infants-examination bathed from lipoprotein metabolism and body composition analysis from birth to 12 months of ages-
Scientific Title:Acronym Study of nutritional support for low birth weight infants
Region
Japan

Condition
Condition low birthweight infant, premature infant, normal birthweight infant
Classification by specialty
Obsterics and gynecology Pediatrics
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Nutritional support for low birthweight infants for prevention of cardiovascular disease in future due to epigenetic effects.
Basic objectives2 Others
Basic objectives -Others To know the relationship between de novo lipogenesis and epigenetic effects in low birthweight infants
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To know the mechanism of modified de novo lipogenesis in low birth weight infants due to epigenetic effects.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 months-old <=
Age-upper limit
12 months-old >=
Gender Male and Female
Key inclusion criteria gestational age
birth weight

RDS
Key exclusion criteria infectious disease
congenital defects
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoo Okada
Organization Nihon university school of medicine
Division name Department of Pediatrics and Child Health
Zip code
Address 30-1 Oyaguchi kamicho, Itabasiku, Tokyo 173-8610, Japan
TEL 0339728111
Email okada.tomoo@nihon-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoo Okada
Organization Department of Pediatrics and Child Health
Division name Department of Pediatrics and Child Health
Zip code
Address 30-1 Oyaguchi kamicho, Itabasiku, Tokyo 173-8610, Japan
TEL 0339728111
Homepage URL
Email okada.tomoo@nihon-u.ac.jp

Sponsor
Institute Department of Pediatrics and Child Health, Nihon University School of Medicine
Institute
Department

Funding Source
Organization Department of Pediatrics and Child Health, Nihon University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Nihon University School of Medicne, Itabashi Hospital
Name of secondary funder(s) Department of Pediatrics and Child Health, Nihon University School of Medicine

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 日本大学板橋病院小児科

Nihon University Itabashi Hospital、Division of Pediatrics

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 09 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
We could obtain the results that the body fatness predominantly has been caught up compared to the body weight   in light for date infants within one month after birth. We found that the role of this mechanism may depend on not only IGF-1 but also LPL, which is the first report as far as we know.
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 Open public recruiting
Date of protocol fixation
2007 Year 06 Month 29 Day
Date of IRB
Anticipated trial start date
2007 Year 06 Month 01 Day
Last follow-up date
2013 Year 02 Month 28 Day
Date of closure to data entry
2014 Year 09 Month 30 Day
Date trial data considered complete
2014 Year 12 Month 31 Day
Date analysis concluded
2015 Year 12 Month 31 Day

Other
Other related information 1) VLDL TG levels in cord blood were shown drastically increasing over than 32 gestational weeks, on the other hand, of which levels were low in infants who accompanied with RDS.
2) LFD infants who was borne over than 37 gestational weeks, whose total skinfold thickness caught up those of AFD in 30 days after birth, but not in body weight.
3) 600 days after impregnation, some LFD infants showed to become heavier and thicker skinfold compared to those of AFD.

Management information
Registered date
2009 Year 09 Month 09 Day
Last modified on
2016 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002399

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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