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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037413
Receipt No. R000041917
Scientific Title 24-hour MII / pH monitoring is an effective tool with the diagnosis of neonatal gastroesophageal reflux disease
Date of disclosure of the study information 2019/07/18
Last modified on 2019/07/18

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Basic information
Public title 24-hour MII / pH monitoring is an effective tool with the diagnosis of neonatal gastroesophageal reflux disease
Acronym 24-hour MII / pH monitoring is an effective tool with the diagnosis of neonatal gastroesophageal reflux disease
Scientific Title 24-hour MII / pH monitoring is an effective tool with the diagnosis of neonatal gastroesophageal reflux disease
Scientific Title:Acronym 24-hour MII / pH monitoring is an effective tool with the diagnosis of neonatal gastroesophageal reflux disease
Region
Japan

Condition
Condition neonatal gastroesophageal reflux disease
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We analyze pH index and total number of regurgitation by Multicahnnel Intraluminal Impedance pH (MII / pH) monitoring for 24 hours and compare with gastroesophageal reflux disease diagnosis by contrast examination.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes pH index, total number of regurgitation and presence or absence of gastroesophageal reflux in contrast examination
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 Self control
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 We can diagnose neonatal gastroesophageal reflux disease and can intervene for assessment of severity.
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
1 years-old >
Gender Male and Female
Key inclusion criteria The symptoms of gastroesophageal reflux disease such as bradycardia, hypoxia, vomiting, and poor weight gain is eligible.
Key exclusion criteria Those who the doctor deems inappropriate or those who do not get consent is excluded.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Mayumi
Middle name
Last name Arakaki
Organization University of Ryukyus, Hospital
Division name Department of Pediatrics
Zip code 903-0125
Address Uehara 207, Nishihara cho, Okinawa
TEL 098-895-3331
Email h133648@med.u-ryukyu.ac.jp

Public contact
Name of contact person
1st name Mayumi
Middle name
Last name Arakaki
Organization University of Ryukyus, Hospital
Division name Department of Pediatrics
Zip code 903-0125
Address Uehara 207, Nishihara cho, Okinawa
TEL 098-895-3331
Homepage URL
Email h133648@med.u-ryukyu.ac.jp

Sponsor
Institute University of Ryukyus, Hospital
Institute
Department

Funding Source
Organization University of Ryukyus, Hospital
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 Univesity of Ryukyus, Hospital
Address Uehara 207, Nishihara cho, Okinawa
Tel 098-895-3331
Email h133648@med.u-ryukyu.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

Other administrative information
Date of disclosure of the study information
2019 Year 07 Month 18 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
2019 Year 07 Month 18 Day
Date of IRB
Anticipated trial start date
2019 Year 07 Month 18 Day
Last follow-up date
2029 Year 06 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 07 Month 18 Day
Last modified on
2019 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041917

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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