UMIN-CTR Clinical Trial

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
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）、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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047266