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Clinical Trials/NCT02749188
NCT02749188
Completed
Not Applicable

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

Fondation Lenval1 site in 1 country43 target enrollmentOctober 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urinary Retention
Sponsor
Fondation Lenval
Enrollment
43
Locations
1
Primary Endpoint
Evaluation of bladder stimulation as a noninvasive technique of urine collection in infants who have not acquired walking
Status
Completed
Last Updated
7 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
October 10, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Fondation Lenval
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Evaluation of bladder stimulation as a noninvasive technique of urine collection in infants who have not acquired walking

Time Frame: 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 Outcomes

  • alternative of the urine sample(During baseline after 2 attemps of bladder stimulation)
  • Evaluation of the tolerance of the infant(During baseline at time 0)
  • evaluation period of urine collection(During baseline at time 0)

Study Sites (1)

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