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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000019892
Receipt No. R000022975
Scientific Title Research on evaluation and usefulness of artificial respiration due to the back and the mask by use of the carbon dioxide monitoring
Date of disclosure of the study information 2015/11/24
Last modified on 2018/05/28

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Basic information
Public title Research on evaluation and usefulness of artificial respiration due to the back and the mask by use of the carbon dioxide monitoring
Acronym The usefulness of carbon dioxide monitoring in neonatal resuscitation
Scientific Title Research on evaluation and usefulness of artificial respiration due to the back and the mask by use of the carbon dioxide monitoring
Scientific Title:Acronym The usefulness of carbon dioxide monitoring in neonatal resuscitation
Region
Japan

Condition
Condition Neonatal infants to perform artificial respiration
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Artificial respiration by bag and mask is a fundamental procedure of neonatal resuscitation and previous intubation. Whether ventilation with bag and mask are effectively done and is determined by the improvement of clinical symptoms and oxygenation. Using the capnogram to verify whether the ventilation is performed effectively.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1.Time until the end-tidal carbon dioxide concentration exceeds 30mmHg by the mask and bag.
2.Time until the oxygen saturation reaches 95% by the mask and bag.
3.Time until the heart rate is equal to or greater than 100 times per minute by the mask and bag.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 It attached a carbon dioxide monitoring immediately after birth for one hour.
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 1.Neonatal
2.Neonatal it is deemed necessary ventilation by bag and mask
3.Neonatal obtained in the document consent with respect to participation in this research
Key exclusion criteria 1.It is accompanied by a severe malformation
2.Suspected chromosomal abnormality
3.Suspected of malformations of the airway system
4.The decision to be inappropriate as a target by the physician's discretion
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuhiko Nagano
Organization Nihon University School of medicine
Division name Department of Pediatrics and Child Health
Zip code
Address 30-1 Ooyaguchi Kamimachi, Itabashi-ku, Tokyo
TEL 03-3972-8111
Email nobuhikofootball@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuhiko Nagano
Organization Nihon University School of medicine
Division name Department of Pediatrics and Child Health
Zip code
Address 30-1 Ooyaguchi Kamimachi, Itabashi-ku, Tokyo
TEL 03-3972-8111
Homepage URL
Email nobuhikofootball@yahoo.co.jp

Sponsor
Institute Department of Pediatrics and Child Health, Nihon University School of Medicine.
Institute
Department

Funding Source
Organization Department of Pediatrics and Child Health, Nihon University School of Medicine.
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
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 24 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
2015 Year 11 Month 24 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 22 Day
Last modified on
2018 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022975

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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