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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041410
Receipt No. R000047266
Scientific Title Effectiveness of a decision support tool in neonatal resuscitation: a multicenter randomized controlled clinical study
Date of disclosure of the study information 2020/09/15
Last modified on 2020/08/18

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Basic information
Public title Effectiveness of a decision support tool in neonatal resuscitation: a multicenter randomized controlled clinical study
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 randomized controlled clinical study
Scientific Title:Acronym Effectiveness of a decision support tool in neonatal resuscitation: a multicenter randomized controlled clinical study
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 or early skin-to-skin contact (SSC) at birth.
Basic objectives2 Others
Basic objectives -Others To determine the accuracy of resuscitation or SSC 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 or SSC.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 With conventional resuscitation or SSC management based on human memory and judgement alone (without using of a decision support tool).
Interventions/Control_2 With using a decision support tool (Japanese Patent 6593900), which provides auditory and visual prompts, in neonatal resuscitation or SSC.
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 1)Cases of resuscitation by a single resuscitator.
2)Cases of SSC more than 100 in each institution.
Target sample size 475

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
Email 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
Email mayu@med.kawasaki-m.ac.jp

Sponsor
Institute Department of Neonatology, Kawasaki Medical School
Institute
Department

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
Email 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)

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 Preinitiation
Date of protocol fixation
2020 Year 08 Month 12 Day
Date of IRB
Anticipated trial start date
2020 Year 09 Month 20 Day
Last follow-up date
2021 Year 02 Month 28 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
2020 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047266

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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