UMIN-CTR Clinical Trial

Basic information
Public title	A study for efficacy of new operation of stimulation at suprapubic and paravertebral zone in infant for collection of urine.
Acronym	OSICCO study
Scientific Title	A study for efficacy of new operation of stimulation at suprapubic and paravertebral zone in infant for collection of urine.
Scientific Title:Acronym	OSICCO study
Region	Japan

Condition
Condition	Good condition
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and safety of a technique for collection of urine, a gentle tapping in the suprapubic area and stimulation of the lumbar paravertebral zone in the lower back, in children under 24 months.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	A proportion of children from whom we can get his/her urine within 5 minutes by the technique.
Key secondary outcomes	1.Comparison of background factors of the group who could urinate and could not 2.Distribution of time of up to urination 3.Proportion of urine occult blood positive in the group that could urinate 4.Proportion of urine protein-positive group that could urinate 5.Proportion of positive for bacterial urine whose urine was obtained. 6.Proportion of the success bacteria were detected by culture:proportion of asymptomatic bacterial urine,and proportion of contamination urine. 7.Proportione of adverse events:patient cry during bladder stimulation, the stimulation give damage to their skin.

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	Maneuver
Interventions/Control_1	A technique for collection of urine, a gentle tapping in the suprapubic area and stimulation of the lumbar paravertebral zone in the lower back.
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	0 months-old <=
Age-upper limit	24 months-old >
Gender	Male and Female
Key inclusion criteria	1.Patients admitted infants aged under 24 months who were registered. 2.Patients who were obtained oral consent to the study by parents or legal parents.
Key exclusion criteria	1.Patient who have completed toilet training. 2.Patient who have abnormality in body temperature, heart rate, respiratory rate, SpO2 or consciousness. 3.Hospitalized patient with urinary tract infection. 4.Patient with known dysuria. 5.Patient with known vesicoureteral reflux. 6.Patient who has HOT (Home oxygen therapy). 7.Patient who havs tracheostomy. 8.Patient who has apneic episode. 9.Neuromuscular disease patient except febrile convulsion. 10.Patient who indicated chromosome aberration. 11.Patient with wounds in the abdomen or back that does not heal. 12.Patient who will be discharged within 3 days. 13.Attending physician does not be in charge of the patient over 24 hours. 14.Attending physician considers inappropriate for the patient.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Satoko Suzuki
Organization	Tokyo Metropolitan Children's Medical Center
Division name	Department of General Pediatrics
Zip code
Address	2-8-29 Musashidai, Fuchu-shi, Tokyo 183-8561, Japan
TEL	042-300-5111
Email	satoko_suzuki@tmhp.jp

Public contact
Name of contact person	1st name Middle name Last name Midori Tanikawa
Organization	Tokyo Metropolitan Children's Medical Center
Division name	Department of General Pediatrics
Zip code
Address	2-8-29 Musashidai, Fuchu-shi, Tokyo 183-8561,Japan
TEL	042-300-5111
Homepage URL	http://www.byouin.metro.tokyo.jp/shouni/
Email	midori_miura@tmhp.jp

Sponsor
Institute	Tokyo Metropolitan Children's Medic Department of General Pediatrics
Institute
Department

Funding Source
Organization	Tokyo Metropolitan Children's Medical Center
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization	Japan

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	東京都立小児総合医療センタ- (Tokyo Metropolitan Children's Medical Center)

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 01 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 08 Month 29 Day
Date of IRB
Anticipated trial start date	2016 Year 10 Month 03 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	2016 Year 09 Month 30 Day
Last modified on	2016 Year 10 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027905

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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