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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041045
Receipt No. R000046500
Scientific Title Prospective study on cerebral blood flow measurement during bathing in neonatal children
Date of disclosure of the study information 2020/07/15
Last modified on 2020/10/05

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Basic information
Public title Newborn's serebral blood flow in bath
Acronym NSBB study
Scientific Title Prospective study on cerebral blood flow measurement during bathing in neonatal children
Scientific Title:Acronym Prospective study on cerebral blood flow measurement during bathing in neonatal children
Region
Japan

Condition
Condition Neonatal children
Classification by specialty
Pediatrics Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to elucidate cerebral blood flow during bathing in neonatal children.
Basic objectives2 Others
Basic objectives -Others Cerebral blood flow is measured during routine work.
Trial characteristics_1 Others
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Regional oxygen saturation before and after bathing.
Key secondary outcomes Evaluate the difference in cerebral blood flow according to age and body weight.

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
28 days-old >=
Gender Male and Female
Key inclusion criteria Gestational age: 37 weeks 0 days to 41 weeks 6 days
Birth weight: 2500g or more
Key exclusion criteria 1) When treatment including replacement fluid is required
2) At birth, in the case of neonatal asphyxia
3) After surgery
4) When bleeding or abnormal coagulation is suspected
5) Respiratory or heart failure requiring oxygen administration
6) If you have digestive symptoms or cold symptoms
7) When congenital malformation is recognized
8) When a chromosomal or genetic abnormality is suspected
9) If the mother is taking antipsychotics or hormones
10) When the doctor in charge determines that it is inappropriate to participate in this study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Tomohiko
Middle name
Last name Nishino
Organization Teikyo University School of Medicine
Division name Department of Pediatrics
Zip code 173-8605
Address 2-11-1, Kaga, Itabashi-ku, Tokyo
TEL 03-3964-4090
Email sinonosino@yahoo.co.jp

Public contact
Name of contact person
1st name Tomohiko
Middle name
Last name Nishino
Organization Teikyo University School of Medicine
Division name Department of Pediatrics
Zip code 173-8605
Address 2-11-1, Kaga, Itabashi-ku, Tokyo
TEL 03-3964-4090
Homepage URL
Email sinonosino@yahoo.co.jp

Sponsor
Institute Department of Pediatrics, Teikyo University School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Teikyo University Medical Research Ethics Committee
Address 2-11-1, Kaga, Itabashi-ku, Tokyo
Tel 03-3964-7256
Email turb-office@teikyo-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 帝京大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2020 Year 07 Month 15 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 Enrolling by invitation
Date of protocol fixation
2020 Year 06 Month 01 Day
Date of IRB
2020 Year 07 Month 09 Day
Anticipated trial start date
2020 Year 07 Month 15 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 10 Month 31 Day
Date trial data considered complete
Date analysis concluded
2022 Year 03 Month 31 Day

Other
Other related information The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Management information
Registered date
2020 Year 07 Month 09 Day
Last modified on
2020 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046500

Research Plan
Registered date File name
2020/10/05 ②0610-1計画書.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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