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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027403
Receipt No. R000031407
Scientific Title Blood sugar and ketone body concentration at the time of the general anesthesia introduction of the cleft lip patient
Date of disclosure of the study information 2017/05/19
Last modified on 2017/05/19

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Basic information
Public title Blood sugar and ketone body concentration at the time of the general anesthesia introduction of the cleft lip patient
Acronym Blood sugar and ketone body concentration at the time of the general anesthesia introduction of the cleft lip patient
Scientific Title Blood sugar and ketone body concentration at the time of the general anesthesia introduction of the cleft lip patient
Scientific Title:Acronym Blood sugar and ketone body concentration at the time of the general anesthesia introduction of the cleft lip patient
Region
Japan

Condition
Condition Healthy babies
Classification by specialty
Anesthesiology Oral surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the blood sugar and ketone body concentration at the time of the general anethesia introduction of the cleft lip babies.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes blood sugar
ketone body concentration
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Measurement of blood sugar at the time of the general anesthesia introduction.
Interventions/Control_2 Measurment of keton body concentration at the time of the general anesthesia introduction.
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
3 months-old <=
Age-upper limit
24 months-old >=
Gender Male and Female
Key inclusion criteria Healthy babies
Key exclusion criteria Bad condition babies
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Harad
Organization Aichi Gakuin University School of Dentistry
Division name Department of Anesthesiology
Zip code
Address 2-11 suemori-dori,Chikusa-ku,Nagoya,Aichi,Japan
TEL 052-759-2111
Email nao.1020@hotmail.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoko Tachi
Organization Aichi Gakuin University School of Dentistry
Division name Department of Anesthesiology
Zip code
Address 2-11 suemori-dori,Chikusa-ku,Nagoya,Aichi,Japan
TEL 052-759-2111
Homepage URL
Email nao.1020@hotmail.co.jp

Sponsor
Institute Aichigakuin Unversity,School of dentistry
Institute
Department

Funding Source
Organization Aichigakuin Unversity,School of dentistry
Organization
Division
Category of Funding Organization Other
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 愛知学院大学歯学部付属病院(愛知県)

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 19 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 Enrolling by invitation
Date of protocol fixation
2016 Year 10 Month 07 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 10 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
2017 Year 05 Month 19 Day
Last modified on
2017 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031407

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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