UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041410 |
|---|---|
| Receipt number | R000047266 |
| Scientific Title | Effectiveness of a decision support tool in neonatal resuscitation: a multicenter clinical study in a crossover manner |
| Date of disclosure of the study information | 2020/09/15 |
| Last modified on | 2021/09/28 15:38:42 |
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Basic information
Public title
Effectiveness of a decision support tool in neonatal resuscitation: a multicenter clinical study in a crossover manner
Acronym
A multicenter study for the effectiveness of using a decision support tool in neonatal resuscitation
Scientific Title
Effectiveness of a decision support tool in neonatal resuscitation: a multicenter clinical study in a crossover manner
Scientific Title:Acronym
Effectiveness of a decision support tool in neonatal resuscitation: a multicenter clinical study in a crossover manner
Region
| Japan |
Condition
Condition
Neonatal birth asphyxia or health newborn
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effectiveness and safety of using a decision support tool (Japanese Patent 6593900) for neonatal resuscitation at birth.
Basic objectives2
Others
Basic objectives -Others
To determine the accuracy of resuscitation documentation in using a decision support tool (Japanese Patent 6593900) .
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Adherence ratio to NRP algorithm evaluated by a scoring system in the major 16 megacodes (checklist) of resuscitation.
Key secondary outcomes
Accuracy of documentation in resuscitation.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
With using a decision support tool (Japanese Patent 6593900), which provides auditory and visual prompts, in neonatal resuscitation.
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
| Not applicable |
Age-upper limit
| 0 | days-old | >= |
Gender
Male and Female
Key inclusion criteria
Sick newborns, with gestational weeks more than 21, requiring for resuscitation at birth or healthy newborns (first 100 cases in each institution) supposed to have SSC at birth.
Key exclusion criteria
Cases of resuscitation by a single resuscitator.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Kawamoto |
Organization
Kawasaki Medical School
Division name
Department of Neonatology
Zip code
701-0192
Address
577 Matsushima, Kurashiki, Okayama, Japan
TEL
+81-86-462-1111
y_kawamoto@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Mayu |
| Middle name | |
| Last name | Yoshii |
Organization
Kawasaki Medical School
Division name
Department of Neonatology
Zip code
701-0192
Address
577 Matsushima, Kurashiki, Okayama, Japan
TEL
+81-86-462-1111
Homepage URL
mayu@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Department of Neonatology, Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Okayama prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School IRB
Address
577 Matsushima, Kurashiki, Okayama, Japan
Tel
+81-86-464-1547
kenkyuhou@med.kawasaki-m.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
川崎医科大学附属病院（岡山県）、住吉母子医療センター（大阪府）、三宅医院（岡山県）、倉敷中央病院（岡山）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 14 | Day |
Last modified on
| 2021 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047266
| Research Plan | |
|---|---|
| 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 |
