UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041045 |
|---|---|
| Receipt number | 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 | 2021/04/01 19:29:01 |
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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
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
sinonosino@yahoo.co.jp
Sponsor or person
Institute
Department of Pediatrics, Teikyo University School of Medicine
Institute
Department
Personal name
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
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
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
18
Results
The rSO2 decreased significantly immediately after bathing and immediately after leaving the bath.
The decrease in rSO2 immediately after bathing showed a significant inverse correlation with water temperature.
Results date posted
| 2021 | Year | 04 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Eligible infants were those born full-term and not of low birth weight.
Infants with first bath, neonatal paralysis, infections, congenital malformations, delivery trauma, and administration of maternal hormones and psychotropic drugs were excluded.
Participant flow
From birth to the day before bathing, written explanations were given to the parents, and only affected children whose consent was obtained were measured.
Adverse events
No adverse events occurred in this study.
Outcome measures
Regional oxygen saturation in during the bathing
Plan to share IPD
Results already registered on this site
IPD sharing Plan description
Results already registered on this site
Progress
Recruitment status
Completed
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 | 04 | Month | 01 | Day |
Date of closure to data entry
| 2021 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2021 | Year | 04 | Month | 01 | Day |
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
| 2021 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.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 |
| 2021/04/01 | 沐浴データ.xlsx |
