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Quick-Wee Versus Bladder Stimulation System to Collect Midstream Urine From Pre-continent Infants (ES-Stimquick U)

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ClinicalTrials.gov Identifier: NCT04587999
Recruitment Status : Not yet recruiting
First Posted : October 14, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Fondation Lenval

Brief Summary:

Urinary tract infections are common in infants. Obtaining urine from pre-continent children can be difficult and time consuming. The method of collection must balance reliability, speed, low rate of contamination, and invasiveness.

According to the American Academy of Pediatrics, midstream clean-catch urine is an acceptable method to diagnose urinary tract infections. However, it is impractical in pre-continent children.

Recently, two quick, safe and effective methods have been reported in the literature:

  • The Quick-wee method: it consists in stimulating the suprapubic area with a cold and wet compress to obtain urines.
  • The bladder stimulation method : the child is held under the armpits with legs dangling and a physician taps the suprapubic area and massages lumbar area alternatively.

However, advanced age, high weight, and level of discomfort during bladder stimulation were significantly associated with failure to obtain urines.


Condition or disease Intervention/treatment Phase
Urinary Tract Infections Other: bladder stimulation Other: Quick wee Not Applicable

Detailed Description:

Urinary tract infections (UTI) are common in infants. The diagnosis of a UTI has important implications for follow-up, and delayed treatment can result in morbidity, including renal scarring and serious bacterial infection.

Obtaining urine from pre-continent children can be difficult and time consuming, the method of collection must balance reliability, speed, low rate of contamination, and invasiveness The actual guidelines recommend suprapubic aspiration or bladder catheterization for collection of urine sample in pre-continent children, but these methods are invasive.

The most common way to collect urines in infants is the use of a sterile collection bag. This is an easy technique, but time consuming and responsible for high rate of contamination, leading to false positives.

According to the American Academy of Pediatrics, midstream clean-catch urine is an acceptable method to diagnose urinary tract infection. However, it is impractical in pre-continent children.

Recently, two quick, safe and effective methods have been reported in the literature:

  • The Quick-wee method: it consists in stimulating the suprapubic area with a cold and wet compress to obtain urines.
  • The bladder stimulation method: the child is held under the armpits with legs dangling and a physician taps the suprapubic area and massages lumbar area alternatively.

However, advanced age, high weight, and level of discomfort during bladder stimulation were significantly associated with failure to obtain urines.

Futhermore, even if urine collection in pre-continent children most often concerns urinary tract infections, these techniques could also be used to look for a metabolic abnormality, an uropathy or a nephropathy (urine electrolyte concentrations, proteinuria, hematuria).

The aim of the study is to compare the effectiveness of two non-invasive midstream urine collection methods in pre-continent children : "the Quick-Wee method" and "the Bladder stimulation method".

The investigators will also compare in the two groups the time required to obtain urine sample, the comfort of the infant during urine collection and the quality of urines.

Finally, for each technique will be analyzed the risk factors associated with failure in obtaining urine sample

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Quick-Wee Versus Bladder Stimulation to Collect Midstream Urine From Pre-continent Infants: a Randomized Controlled Trial
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: bladder stimulation Other: bladder stimulation

The bladder stimulation technique requires the presence of 2 people:

  • The child must be held by an adult (caregiver or parent) under the armpits, legs dangling.
  • the first person (the investigator), performs the stimulation technique consisting of: rapid tapping (frequency of about 100 / min), over the pubic area, at the level of the bladder, alternated with external rotational movements of the pits lumbar, in the kidneys. Alternate these 2 maneuvers every 30 seconds.
  • The second person starts the stopwatch at the start of the stimulation, and is about to collect the urine, 2nd jet in a sterile pot
  • The maneuver ends as soon as urine is obtained, and will be stopped after 5 minutes in case of failure.

Active Comparator: Quick wee Other: Quick wee

The Quick wee technique requires the presence of only one person:

Stimulation of the suprapubic area by circular movements, with a cold and wet compress held by sterile forceps.

Collection of urine in a sterile container.





Primary Outcome Measures :
  1. volume of urine collection to measure the effectiveness of two techniques [ Time Frame: at the end of intervention completion, an average 30 minutes ]
    measure of success of the urine collection technique is determined by collecting at least 2 millimeters of urine in less than 5 minutes


Secondary Outcome Measures :
  1. time needed to obtain urines [ Time Frame: at the end of intervention completion, an average 30 minutes ]
    measure of times needed to obtain urines in minutes and seconds

  2. patient comfort [ Time Frame: through intervention completion, an average 30 minutes ]

    pain is measured by Evaluation ENfant DOuLeur (EVENDOL) scale while the technique is performed. EVENDOL is a pain scale for children under 7. A pain scale validated for children from birth to 7 years. Score ranges from 0 to 15.

    Treatment threshold: 4/15.


  3. Bacterial contamination rates of urine samples [ Time Frame: at 48 hours after inclusion ]

    Measure of bacterial contamination of urine sample is by:

    • numeration the growth of two or more micro-organisms,
    • Or numeration the presence of a non-uropathogenic germ (lactobacilli, Staphylococcus Coagulase negative, Corynebacterium),
    • or numeration a bacteriuria> 0 colony forming unit(CFU)/millimeters (mL) but <10˄4 CFU / ml for bladder catheterization and <10˄5 CFU / mL for clean catch urine collected by bladder stimulation, or leukocyturia <10˄4 / mL

  4. collection of patient data to define risk factors associated with the failure of the bladder stimulation techniques [ Time Frame: through intervention completion, an average 30 minutes ]
    collection patient data : pain, weight, sex, age, last food and time since last collect urine The goal is to define potential risk factors to failure urine collection (urinary sample quantity < 2 millimeters or no urinary sample collected)



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants under the age of 1 year
  • For whom an urine sample is required for the diagnosis of a urinary tract infection, uropathy, nephropathy, metabolic disease
  • Obtaining the authorization of the holders of parental authority

Exclusion Criteria:

  • Do exhibiting signs of vital distress
  • Withdrawal of informed consent by parents or holders of parental authority
  • Transfer of the child to a hospital unit after the 1st attempt

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04587999


Contacts
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Contact: Sarah MARCHAL, MD 4 92 03 04 42 ext +33 marchal.s@pediatrie-chulenval-nice.fr
Contact: Antoine TRAN, MD tran.a@pediatrie-chulenval-nice.fr

Locations
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France
Hôpitaux Pédiatriques de Nice CHU-Lenval
Nice, France
Contact: Sarah MARCHAL, MD       marchal.s@pediatrie-chulenval-nice.fr   
Principal Investigator: Sarah MARCHAL, MD         
Sponsors and Collaborators
Fondation Lenval
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Responsible Party: Fondation Lenval
ClinicalTrials.gov Identifier: NCT04587999    
Other Study ID Numbers: 20-HPNCL-04
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Tract Infections
Infection
Urologic Diseases