<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03263845</url>
  </required_header>
  <id_info>
    <org_study_id>35RC16_3036_SONDAPU</org_study_id>
    <nct_id>NCT03263845</nct_id>
  </id_info>
  <brief_title>Evaluation of Pain in Urinary Collections in Pediatric Emergencies in Children Who Have Not Acquired Cleanliness</brief_title>
  <acronym>SONDAPU</acronym>
  <official_title>Round-trip Survey or Urine Bag: Evaluation of Pain in Urinary Collections in Pediatric Emergencies in Children Who Have Not Acquired Cleanliness (SONDAPU)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Observational study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Febrile urinary infections account for 5% of unexplained causes of fever in children up to 2&#xD;
      years of age. Urinary samples are therefore very common in pediatric emergencies. In children&#xD;
      who have not acquired cleanliness, the most used method of collection is the placement of a&#xD;
      sterile urine bag on the perineum. It allows a noninvasive urinary collection. However from a&#xD;
      bacteriological point of view this method is debatable because the rate of contamination of&#xD;
      the collections is important. This mode of collection is of interest only to exclude a&#xD;
      urinary infection, by the realization of a urinary strip.&#xD;
&#xD;
      Pocket-collected urine is not reliable for bacteriological analysis in culture. For example,&#xD;
      if the urine strip is positive, the American Academy of Pediatrics recommends urine sampling&#xD;
      by urine sampling (or other invasive methods) for culture.&#xD;
&#xD;
      The urine bag should be changed every 30 minutes to avoid the risk of contamination. The&#xD;
      technique is wait-and-see, the installation of several pockets is often necessary before&#xD;
      obtaining urine.&#xD;
&#xD;
      A study carried out in 2014 shows that in 39.4% of the cases the withdrawal of the urinary&#xD;
      pouch was as much more painful than the urinary sounding, in the same patient. To our&#xD;
      knowledge there is no other study dealing with the difference in pain engendered by these two&#xD;
      methods.&#xD;
&#xD;
      Since the urinary catheterization is faster, bacteriologically justified and necessary if the&#xD;
      pocket collection is positive, it seems legitimate to ask ourselves if we should not aim at a&#xD;
      generalization of the urinary catheterization, as first intention, Having not acquired&#xD;
      cleanliness, requiring a withdrawal of urine for suspicion of urinary infection.&#xD;
&#xD;
      Many centers continue to use urinary pocket collection mainly, as the survey technique seems&#xD;
      too invasive and painful.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 5, 2016</start_date>
  <completion_date type="Actual">January 13, 2017</completion_date>
  <primary_completion_date type="Actual">January 13, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of pain</measure>
    <time_frame>Day 0</time_frame>
    <description>Score of the visual analog scale rated by the caregiver during the first performed gesture.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of pain</measure>
    <time_frame>Day 0</time_frame>
    <description>Score of the visual analog scale rated by the parent during the first performed gesture.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of pain</measure>
    <time_frame>Day 0</time_frame>
    <description>Score of the visual analog scale rated by the parent and the caregiver for the following gestures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The experience of the gesture by the parent and the caregiver</measure>
    <time_frame>Day 0</time_frame>
    <description>Evaluation by a questionnaire by choosing from the following proposals:&#xD;
Very well spent, well spent, badly spent or very badly spent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time needed to collect urine</measure>
    <time_frame>Day 0</time_frame>
    <description>Duration between the first gesture and the final urine collection</description>
  </secondary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Urinary Tract Infections in Children</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Children under 3 years of age who have not acquired the cleanliness present at the&#xD;
        pediatric emergency department in Rennes, where urine sampling is necessary in case of&#xD;
        suspected urinary tract infection.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Children under 3 years of age who have not acquired the cleanliness present at the&#xD;
        pediatric emergency department in Rennes, where urine sampling is necessary in case of&#xD;
        suspected urinary tract infection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>3 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amelie Rickewaert</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rennes University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rennes University Hospital</name>
      <address>
        <city>Rennes</city>
        <zip>35200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>August 24, 2017</last_update_submitted>
  <last_update_submitted_qc>August 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Tract Infections</mesh_term>
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03263845
org study id: 35RC16_3036_SONDAPU
nct id: NCT03263845
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Observational study.
Febrile urinary infections account for 5% of unexplained causes of fever in children up to 2
      years of age. Urinary samples are therefore very common in pediatric emergencies. In children
      who have not acquired cleanliness, the most used method of collection is the placement of a
      sterile urine bag on the perineum. It allows a noninvasive urinary collection. However from a
      bacteriological point of view this method is debatable because the rate of contamination of
      the collections is important. This mode of collection is of interest only to exclude a
      urinary infection, by the realization of a urinary strip.

      Pocket-collected urine is not reliable for bacteriological analysis in culture. For example,
      if the urine strip is positive, the American Academy of Pediatrics recommends urine sampling
      by urine sampling (or other invasive methods) for culture.

      The urine bag should be changed every 30 minutes to avoid the risk of contamination. The
      technique is wait-and-see, the installation of several pockets is often necessary before
      obtaining urine.

      A study carried out in 2014 shows that in 39.4% of the cases the withdrawal of the urinary
      pouch was as much more painful than the urinary sounding, in the same patient. To our
      knowledge there is no other study dealing with the difference in pain engendered by these two
      methods.

      Since the urinary catheterization is faster, bacteriologically justified and necessary if the
      pocket collection is positive, it seems legitimate to ask ourselves if we should not aim at a
      generalization of the urinary catheterization, as first intention, Having not acquired
      cleanliness, requiring a withdrawal of urine for suspicion of urinary infection.

      Many centers continue to use urinary pocket collection mainly, as the survey technique seems
      too invasive and painful.
observational model: Case-Only
time perspective: Prospective
measure: Evaluation of pain
time frame: Day 0
description: Score of the visual analog scale rated by the caregiver during the first performed gesture.
measure: Evaluation of pain
time frame: Day 0
description: Score of the visual analog scale rated by the parent during the first performed gesture.
measure: Evaluation of pain
time frame: Day 0
description: Score of the visual analog scale rated by the parent and the caregiver for the following gestures
measure: The experience of the gesture by the parent and the caregiver
time frame: Day 0
description: Evaluation by a questionnaire by choosing from the following proposals:
Very well spent, well spent, badly spent or very badly spent
measure: Time needed to collect urine
time frame: Day 0
description: Duration between the first gesture and the final urine collection
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 3 Years
healthy volunteers: No
last name: Amelie Rickewaert
role: Principal Investigator
affiliation: Rennes University Hospital
facility: 
country: France
responsible party type: Sponsor
mesh term: Urinary Tract Infections
mesh term: Emergencies