Clinical trial NCT02749188: Evaluation of Bladder Stimulation as a Noninvasive Technique of Urine Collection in Infant Who Have Not Acquired Walking
Official title: Evaluation of Bladder Stimulation as a Noninvasive Technique of Urine Collection in Infants Who Have Not Acquired Walking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Retention
Keywords: Urine Specimen Collection/methods
Infant
Newborn
Feasibility Studies
Bladder stimulation
Lead sponsor: Fondation Lenval
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 43
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of bladder stimulation as a noninvasive technique of urine collection in infants who have not acquired walking
timeFrame: During baseline at time 0
Secondary outcomes:
measure: evaluation period of urine collection
timeFrame: During baseline at time 0
measure: Evaluation of the tolerance of the infant
timeFrame: During baseline at time 0
measure: alternative of the urine sample
timeFrame: During baseline after 2 attemps of bladder stimulation
Other outcomes:
Locations:
city: Nice
country: France
facility: Fondation Lenval
Study officials:
affiliation: Fondation Lenval
name: Antoine TRAN, MD
role: PRINCIPAL_INVESTIGATOR
References: