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

NCT02749188 | Completed

• 1 other identifier: 14-HPNCL-07
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Retention

Keywords

Urine Specimen Collection/methods; Infant; Newborn; Feasibility Studies; Bladder stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• evaluation period of urine collection

  During baseline at time 0

• Evaluation of the tolerance of the infant

  During baseline at time 0

• alternative of the urine sample

  During baseline after 2 attemps of bladder stimulation

Study Arms (1)

bladder stimulation

OTHER

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

Interventions

Bladder stimulation OTHER

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

bladder stimulation

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Lenval: lead

Study Sites (1)

Fondation Lenval

Nice, 06200, France

Location

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Antoine TRAN, MD

  Fondation Lenval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: April 22, 2016
• Study Start: October 1, 2014
• Primary Completion: October 10, 2017
• Study Completion: October 10, 2017
• Last Updated: July 31, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)