UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019892
Receipt number 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 2020/05/26 12:40:29

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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 Nobuhiko
Middle name
Last name Nagano

Organization

Nihon University School of medicine

Division name

Department of Pediatrics and Child Health

Zip code

173-8610

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 Nobuhiko
Middle name
Last name Nagano

Organization

Nihon University School of medicine

Division name

Department of Pediatrics and Child Health

Zip code

173-8610

Address

30-1 Ooyaguchi Kamimachi, Itabashi-ku, Tokyo

TEL

03-3972-8111

Homepage URL


Email

nobuhikofootball@yahoo.co.jp


Sponsor or person

Institute

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

Institute

Department

Personal name



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

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

Address

Ooyaguchikamimachi30-1,itabashi-ku

Tel

03-3972-8111

Email

nobuhikofootball@yahoo.co.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



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

Terminated

Date of protocol fixation

2015 Year 11 Month 24 Day

Date of IRB

2015 Year 11 Month 09 Day

Anticipated trial start date

2015 Year 11 Month 24 Day

Last follow-up date

2021 Year 12 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

2015 Year 11 Month 22 Day

Last modified on

2020 Year 05 Month 26 Day



Link to view the page

Value
https://center6.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