UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037413 |
|---|---|
| Receipt number | 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 | 2021/01/27 14:29:46 |
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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
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
h133648@med.u-ryukyu.ac.jp
Sponsor or person
Institute
University of Ryukyus, Hospital
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2019 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 18 | Day |
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
| 2021 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041917
