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

F

Fondation Lenval

Status

Completed

Conditions

Urinary Retention

Treatments

Other: Bladder stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT02749188
14-HPNCL-07

Details and patient eligibility

About

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.

Full 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

Enrollment

43 patients

Sex

All

Ages

Under 24 months old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

43 participants in 1 patient group

bladder stimulation
Other group
Description:
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.
Treatment:
Other: Bladder stimulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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