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

Study Overview
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Brief Summary
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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.

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

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

Conditions
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Urinary Retention

Intervention / Treatment
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* Other: Bladder stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: bladder stimulation<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of bladder stimulation as a noninvasive technique of urine collection in infants who have not acquired walking | • 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. | During baseline at time 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation period of urine collection | If successful, the evaluation period, in seconds, of urine collection using a chronometer (between the start of bladder stimulation and obtaining the urine) | During baseline at time 0 | 
| Evaluation of the tolerance of the infant | Evaluation of the tolerance of the infant undergoing stimulation technique using wide EVENDOL scale pain, noted on 15 | During baseline at time 0 | 
| alternative of the urine sample | 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 | During baseline after 2 attemps of bladder stimulation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urine Specimen Collection/methods, Infant, Newborn, Feasibility Studies, Bladder stimulation