UMIN-CTR Clinical Trial

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

Good condition

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Tokyo Metropolitan Children's Medic
Department of General Pediatrics

Institute

Department

Personal name

Organization

Tokyo Metropolitan Children's Medical Center

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

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

Date of disclosure of the study information

2016

Year

10

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

09

Month

30

Day

Last modified on

2016

Year

10

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027905