StiVeN: Evaluation of Bladder Stimulation as a Noninvasive Technique of Urine Collection in Infant Who Have Not Acquired Walking

Sponsor

Fondation Lenval (Other)

Overall Status

Completed

CT.gov ID

NCT02749188

Collaborator

(none)

Enrollment

Location

Arm

36.3

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The urinary tract infections are common in children. It is estimated that about 3% of girls and 1% of boys suffer from a urinary tract infection before the age of 11 years. A prompt diagnosis and treatment are necessary for the prevention of morbidity and long-term sequelae.

Currently, there are different methods of urine collection, such as suprapubic aspiration, the survey, the collection bag and the jet medium collection.

They have in common to be time-consuming, invasive in some cases, providers of contaminated levies for others and impossible in children incontinent for the last.

A Spanish study developed a new collection technique, for kidney and bladder stimulation, noninvasive, in the new-born to 30-day months. The results are promising with a success rate of over 85% within a period of about 45s.

No study has looked at a broader pediatric population, including children from birth to age of acquisition of walking.

We hypothesize that it is possible to obtain urine in less than 3 minutes, noninvasively, in infants who have not acquired the works for which a urine sample is required.

Condition or Disease	Intervention/Treatment	Phase
Urinary Retention	Other: Bladder stimulation	N/A

Detailed Description

Currently, there are different methods of urine collection, such as suprapubic aspiration, the survey, the collection bag and the jet medium collection.

They have in common to be time-consuming, invasive in some cases, providers of contaminated levies for others and impossible in children incontinent for the last.

No study has looked at a broader pediatric population, including children from birth to age of acquisition of walking.

We hypothesize that it is possible to obtain urine in less than 3 minutes, noninvasively, in infants who have not acquired the works for which a urine sample is required.

The main objective is the Evaluation of bladder stimulation as a noninvasive technique of urine collection in infants who have not acquired walking

Study Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Evaluation of Bladder Stimulation as a Noninvasive Technique of Urine Collection in Infants Who Have Not Acquired Walking

Actual Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Oct 10, 2017

Actual Study Completion Date :

Oct 10, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: bladder stimulation Bladder stimulation as a noninvasive technique of urine collection. The renal and bladder stimulation will be performed in less than 3 minutes, with a maximum of two attempts spaced about 20 minutes.	Other: Bladder stimulation Bladder stimulation as a noninvasive technique of urine collection. The renal and bladder stimulation will be performed in less than 3 minutes, with a maximum of two attempts spaced about 20 minutes

Arm

Intervention/Treatment

Other: bladder stimulation

Bladder stimulation as a noninvasive technique of urine collection. The renal and bladder stimulation will be performed in less than 3 minutes, with a maximum of two attempts spaced about 20 minutes.

Other: Bladder stimulation

Bladder stimulation as a noninvasive technique of urine collection. The renal and bladder stimulation will be performed in less than 3 minutes, with a maximum of two attempts spaced about 20 minutes

Outcome Measures

Primary Outcome Measures

Evaluation of bladder stimulation as a noninvasive technique of urine collection in infants who have not acquired walking [During baseline at time 0]
• Obtaining urine or not (YES / NO) by bladder stimulation in less than 3 minutes (max 2 attempts). This is evaluated by an investigator who directs the bladder stimulation technique.

Secondary Outcome Measures

evaluation period of urine collection [During baseline at time 0]
If successful, the evaluation period, in seconds, of urine collection using a chronometer (between the start of bladder stimulation and obtaining the urine)
Evaluation of the tolerance of the infant [During baseline at time 0]
Evaluation of the tolerance of the infant undergoing stimulation technique using wide EVENDOL scale pain, noted on 15
alternative of the urine sample [During baseline after 2 attemps of bladder stimulation]
In case of failure, the investigator who included infants in the study will specify the alternative of the urine sample from: collection bag, survey, suprapubic aspiration, and the success or failure of this alternative

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 24 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Infants under the age of 2 years and who have not acquired walking
To which the investigating doctor asked the indication of a urine sample in search of a urinary tract infection, ionic and metabolic disorder
Do not exhibiting signs of vital distress (respiratory or circulatory or neurological)
To which the bladder stimulation does not delay the treatment
Obtaining the authorization of the holders of parental authority
Affiliation to social security
Clinical examination

Exclusion Criteria:

Parental Refusal
Infants> 2 years or who has walking
Infant occurring outside the pediatric emergency timetables of care permanently
Infant having vital signs of distress (respiratory and / or circulatory and / or neurological)
Infant for which the bladder stimulation could delay the management