Clinical Trials Directory

Trials / Completed

CompletedNCT02749188

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
43 (actual)
Sponsor
Fondation Lenval · Academic / Other
Sex
All
Age
24 Months
Healthy volunteers
Accepted

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

Conditions

Interventions

TypeNameDescription
OTHERBladder stimulationBladder 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

Timeline

Start date
2014-10-01
Primary completion
2017-10-10
Completion
2017-10-10
First posted
2016-04-22
Last updated
2018-07-31

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02749188. Inclusion in this directory is not an endorsement.