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

Primary Purpose

Urinary Retention

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Bladder stimulation
Sponsored by
Fondation Lenval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Urinary Retention focused on measuring Urine Specimen Collection/methods, Infant, Newborn, Feasibility Studies, Bladder stimulation

Eligibility Criteria

undefined - 24 Months (Child)All SexesAccepts 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

Sites / Locations

  • Fondation Lenval

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

bladder stimulation

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

evaluation period of urine collection
If successful, the evaluation period, in seconds, of urine collection using a chronometer (between the start of bladder stimulation and obtaining the urine)
Evaluation of the tolerance of the infant
Evaluation of the tolerance of the infant undergoing stimulation technique using wide EVENDOL scale pain, noted on 15
alternative of the urine sample
In case of failure, the investigator who included infants in the study will specify the alternative of the urine sample from: collection bag, survey, suprapubic aspiration, and the success or failure of this alternative

Full Information

First Posted
April 20, 2016
Last Updated
July 27, 2018
Sponsor
Fondation Lenval
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1. Study Identification

Unique Protocol Identification Number
NCT02749188
Brief Title
Evaluation of Bladder Stimulation as a Noninvasive Technique of Urine Collection in Infant Who Have Not Acquired Walking
Acronym
StiVeN
Official Title
Evaluation of Bladder Stimulation as a Noninvasive Technique of Urine Collection in Infants Who Have Not Acquired Walking
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
October 10, 2017 (Actual)
Study Completion Date
October 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Lenval

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention
Keywords
Urine Specimen Collection/methods, Infant, Newborn, Feasibility Studies, Bladder stimulation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bladder stimulation
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
Bladder stimulation
Intervention 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
Primary Outcome Measure Information:
Title
Evaluation of bladder stimulation as a noninvasive technique of urine collection in infants who have not acquired walking
Description
• 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.
Time Frame
During baseline at time 0
Secondary Outcome Measure Information:
Title
evaluation period of urine collection
Description
If successful, the evaluation period, in seconds, of urine collection using a chronometer (between the start of bladder stimulation and obtaining the urine)
Time Frame
During baseline at time 0
Title
Evaluation of the tolerance of the infant
Description
Evaluation of the tolerance of the infant undergoing stimulation technique using wide EVENDOL scale pain, noted on 15
Time Frame
During baseline at time 0
Title
alternative of the urine sample
Description
In case of failure, the investigator who included infants in the study will specify the alternative of the urine sample from: collection bag, survey, suprapubic aspiration, and the success or failure of this alternative
Time Frame
During baseline after 2 attemps of bladder stimulation

10. Eligibility

Sex
All
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine TRAN, MD
Organizational Affiliation
Fondation Lenval
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondation Lenval
City
Nice
ZIP/Postal Code
06200
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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