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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000024231 |
Receipt No. | R000027905 |
Scientific Title | A study for efficacy of new operation of stimulation at suprapubic and paravertebral zone in infant for collection of urine. |
Date of disclosure of the study information | 2016/10/01 |
Last modified on | 2016/10/06 |
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 |
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Condition | ||
Condition | Good condition | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
satoko_suzuki@tmhp.jp |
Public contact | |||||||
Name of contact person |
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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/ | ||||||
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 | |
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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 |
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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 | |
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Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Enrolling by invitation | ||||||
Date of protocol fixation |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |