UMIN-CTR Clinical Trial

Basic information
Public title	The cause of low birth weight infant
Acronym	The cause of low birth weight infant
Scientific Title	The cause of low birth weight infant
Scientific Title:Acronym	The cause of low birth weight infant
Region	Japan

Condition
Condition	Neonate
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The cause of low birth weight infant
Basic objectives2	Others
Basic objectives -Others	Research about the cause
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood, urine sample evaluation
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	1 days-old <=
Age-upper limit	1 years-old >
Gender	Male and Female
Key inclusion criteria	Neonates admitted in NIUC of Tokushima university hospital and Kobe university hospital
Key exclusion criteria	No permission from parents
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Nobuto Middle name Last name Nakanishi
Organization	Tokushima university hospital
Division name	Emergency and critical care medicine
Zip code	770-8503
Address	2-50-1 Kuramoto, Tokushima, Japan, 770-8503
TEL	088-633-9347
Email	nobuto_nakanishi@yahoo.co.jp

Public contact
Name of contact person	1st name Nobuto Middle name Last name Nakanishi
Organization	Tokushima University Hospital
Division name	Emergency and Critical Care Medicine
Zip code	770-8503
Address	2-50-1 Kuramoto, Tokushima, Japan, 770-8503
TEL	088-633-9347
Homepage URL
Email	nobuto_nakanishi@yahoo.co.jp

Sponsor
Institute	The university of Tokushima
Institute
Department

Funding Source
Organization	The university of Tokushima
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kobe University Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokushima University Hospital
Address	2-50-1 Kuramoto, Tokushima, Japan, 770-8503
Tel	088-633-9294
Email	awachiken@tokushima-u.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	1425
Org. issuing International ID_1	Tokushima University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	徳島大学病院（徳島県）、神戸大学病院（兵庫県）

Other administrative information
Date of disclosure of the study information	2020 Year 12 Month 16 Day

Related information
URL releasing protocol	https://www.nature.com/articles/s41390-021-01658-5
Publication of results	Published

Result
URL related to results and publications	https://www.nature.com/articles/s41390-021-01658-5
Number of participants that the trial has enrolled	219
Results	Urinary titin N-fragment exponentially declined with postmenstrual age. These values were increased at very and extremely preterm infants (p<0.01).
Results date posted	2021 Year 07 Month 20 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Infants
Participant flow	Retrospective study
Adverse events	No
Outcome measures	urinary titin N-fragment levels of urinary samples
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 01 Day
Date of IRB	2017 Year 10 Month 02 Day
Anticipated trial start date	2017 Year 10 Month 10 Day
Last follow-up date	2020 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The research about the causes of low birth weight infant by using blood and urine remaining samples of neonates.

Management information
Registered date	2020 Year 12 Month 15 Day
Last modified on	2021 Year 07 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048800