<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/NCT01726166</url>
  </required_header>
  <id_info>
    <org_study_id>2011813-01H</org_study_id>
    <nct_id>NCT01726166</nct_id>
  </id_info>
  <brief_title>Suprapubic Aspiration Versus Urinary Catheterization In Neonates.</brief_title>
  <acronym>SPA</acronym>
  <official_title>A Randomized Controlled Trial: Suprapubic Aspiration Versus Urinary Catheterization in the Neonatal Intensive Care Unit.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital of Eastern Ontario</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Physicians' Services Incorporated Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital of Eastern Ontario</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Urinary tract infection (UTI) is relatively common in infants, with an occurence rate of up&#xD;
      to 10%.&#xD;
&#xD;
      Analysis of collected urine for the presence of bacteria or fungus is the only way to make a&#xD;
      certain UTI diagnosis. Sterile collection of urine can be achieved in newborn infants by&#xD;
      urinary catheterization (UC) where a catheter is passed through the urethra into the bladder,&#xD;
      suprapubic aspiration (SPA) where a needle is inserted into the bladder through the abdominal&#xD;
      wall, or 'clean catch' where urine is collected into a sterile bottle as the baby urinates&#xD;
      during preparation for UC. The main advantage of SPA is that it bypasses the bacteria that&#xD;
      normally resides in the urethral opening, thus minimizing the risk of contamination. Some&#xD;
      studies have suggested that SPA is better than UC for collecting urine in a sterile fashion&#xD;
      in the neonate due to the difficulty of doing sterile UC in small infants resulting in more&#xD;
      contaminated samples (also called a false-positive urine culture); there is still no clear&#xD;
      best choice. UC is commonly used in many Neonatal Intensive Care Units (NICU) as it is&#xD;
      considered less invasive, can be done by the nursing staff, and generally has a higher chance&#xD;
      of obtaining urine. SPA is a simple and safe alternative and, although it may be more painful&#xD;
      than UC, it is performed more quickly. The reported success rate for SPA is variable, but is&#xD;
      greatly increased when an ultrasound confirms urine in the bladder. The question remains:&#xD;
      what is the best method for sterile collection of urine in neonates? In this study, the&#xD;
      investigators will try to answer this question by collecting urine from neonates using either&#xD;
      ultrasound guided SPA or UC and then comparing the contamination rates between these two&#xD;
      methods.&#xD;
&#xD;
      The investigators hypothesize that SPA will result in less contamination of urine samples.&#xD;
&#xD;
      The investigators also hypothesize that there will be more success in obtaining an adequate&#xD;
      urine sample (0.5 ml) by SPA, and that there will be no difference in associated complication&#xD;
      rates between SPA and UC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      See above and other sections.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow recruitment over 3 yrs (n=47). No chance to reach sample size (n=~160).&#xD;
  </why_stopped>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of contaminated urine samples per SPA and UC</measure>
    <time_frame>up to 2 years</time_frame>
    <description>For SPA samples, urine contamination will be defined as the growth of two or more micro-organisms (any number of colonies per each microorganism) or the growth of Candida species plus growth of any other microorganism.&#xD;
For UC samples, urine contamination will be defined as the growth of two or more micro-organisms (any number of colonies per each microorganism) or any growth &lt;10^4 colony forming unit(CFU)/ml or the growth of Candida species plus growth of any other microorganism.&#xD;
The different cut-off used for contamination between UC and SPA samples stems from the fact that the UC procedure is not sterile in the neonatal population.&#xD;
Note that a bacterial load of &lt;10^3 CFU/mL (e.g. 10^1 or 10^2 CFU/mL) does not grow in the media of either laboratory where our study samples are being cultured.&#xD;
Further sensitivity analyses will be performed on this outcome measure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Success rates of obtaining urine by SPA versus UC</measure>
    <time_frame>up to 2 years</time_frame>
    <description>Successful withdrawal of urine is defined as obtaining 0.5ml of urine during an attempt at SPA or UC. This is the quantity required by our laboratory for urine culture.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to perform the respective procedures</measure>
    <time_frame>up to 2 years</time_frame>
    <description>Start time will be recorded as initiation of sterile preparation of the skin. Finish time will be recorded as removal of SPA needle or UC catheter. In the event that the catheter is to remain indwelling, finish time will be recorded as the cessation of sample collection for culture</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication rates of SPA versus UC</measure>
    <time_frame>up to 2 years</time_frame>
    <description>UC complications&#xD;
macroscopic hematuria within 48 hours after the procedure including the first void.&#xD;
urinary retention (completely dry diaper with the presence of a distended bladder based on palpation and/or percussion) within the first 4 hours after the procedure.&#xD;
SPA complications&#xD;
macroscopic hematuria within 48 hours after the procedure including the first void after the procedure.&#xD;
bowel perforation defined as the aspiration of stool contents or clinical and radiographic signs present within 4-6 hrs after the procedure.&#xD;
suprapubic hematoma or abscess occurring within 1 week after the procedure&#xD;
clinical peritonitis based on the new presence of some or all of the following: fever, tachycardia, absent bowel sounds, abdominal distension, guarding, rigidity or tenderness, and vomiting occuring within 72 hours after the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contamination rates of SPA versus UC (excluding clean catch urine)</measure>
    <time_frame>up to 2 years</time_frame>
    <description>Since the investigators will collect a clean catch urine sample if the randomly assigned infant passes urine spontaneously during a UC attempt but not during SPA attempt, the investigators will compare the contamination rates per UC versus SPA with the exclusion of clean catch samples to ensure pure comparison between the two procedures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of attempts per procedure</measure>
    <time_frame>up to 2 years</time_frame>
    <description>For UC: each time a urinary catheter is introduced through the foreskin or the urethral meatus, this will be considered one attempt.&#xD;
For SPA: each time the skin is punctured by the needle, this will be considered one attempt. This allows for an attempt to include redirection of the needle as long as it remains beneath the skin.&#xD;
We will be assessing for a procedural learning curve through this outcome measure and the data recorded.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Neonatal Urinary Tract Infection</condition>
  <arm_group>
    <arm_group_label>Suprapubic Aspiration</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A trained physician or neonatal nurse practitioner utilizing U/S guidance at the bedside will perform the SPA. An U/S machine is readily available for use in each NICU.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Urinary Catheterization</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The infants will have the procedure done by NICU nurses who have been trained in performing this procedure.&#xD;
If the randomly assigned infant passes urine spontaneously during a UC attempt after complete perineal cleansing and the urine is collected as a &quot;clean catch&quot; sample, then this infant will be analysed in the assigned group (intention to treat).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Suprapubic Aspiration</intervention_name>
    <description>Pain management will be performed as per our NICU protocols by administering 24% sucrose prior to both procedures to ensure adequate pain control. Additional or different analgesia may be used depending on the patient's specific clinical situation. We will use a chlorhexidine 0.05% with no cetrimide solution as the cleaning solution.</description>
    <arm_group_label>Suprapubic Aspiration</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Urinary Catheterization</intervention_name>
    <description>Pain management will be performed as per our NICU protocols by administering 24% sucrose prior to both procedures to ensure adequate pain control. Additional or different analgesia may be used depending on the patient's specific clinical situation. We will use a chlorhexidine 0.05% with no cetrimide solution as the cleaning solution.</description>
    <arm_group_label>Urinary Catheterization</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria (to be approached for consent):&#xD;
&#xD;
        -All infants who are admitted to the NICU and are not known to have the exclusion criteria&#xD;
        listed below at the time of admission&#xD;
&#xD;
        Exclusion criteria (to be approached for consent):&#xD;
&#xD;
          -  Antenatal detection or suspicion of genitourinary anomaly including: ambiguous&#xD;
             genitalia, hypospadias, posterior urethral valve, anal atresia, exstrophy-epispadias&#xD;
             complex, and oligohydramnios secondary to probable genitourinary anomaly(e.g. renal&#xD;
             agenesis, multicystic kidney disease)&#xD;
&#xD;
          -  Antenatal hydrops&#xD;
&#xD;
          -  Antenatally detected abdominal wall defect or abdominal masses&#xD;
&#xD;
          -  Antenatally detected grossly dilated bowel loops&#xD;
&#xD;
          -  Congenital abdominal skin lesion over the SPA puncture site&#xD;
&#xD;
        Inclusion criteria (prior to randomization):&#xD;
&#xD;
        -All infants who are greater than 72 hours of age, who are being investigated for a&#xD;
        possible UTI, and have been consented will be eligible for randomization&#xD;
&#xD;
        Exclusion criteria (prior to randomization):&#xD;
&#xD;
          -  Oliguria (&lt;0.5 cc/kg/hr) or anuria over the 8 hours prior to attempted urine&#xD;
             collection&#xD;
&#xD;
          -  Skin infection over the SPA puncture site&#xD;
&#xD;
          -  Distension or enlargement of abdominal viscera (e.g. grossly dilated loops of bowel or&#xD;
             massive organomegaly)&#xD;
&#xD;
          -  Active Necrotizing enterocolitis (Bell stage II or more)&#xD;
&#xD;
          -  Uncorrected thrombocytopenia (platelets &lt; 50 x 10 6) or bleeding diathesis&#xD;
&#xD;
          -  Post-abdominal surgery&#xD;
&#xD;
          -  Large inguinal hernia&#xD;
&#xD;
          -  Current pre-existing indwelling catheter&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>72 Hours</minimum_age>
    <maximum_age>12 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gregory P Moore, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital of Eastern Ontario; Ottawa Hospital; University of Ottawa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital of Eastern Ontario</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ottawa Hospital - General campus</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6, K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>January 21, 2020</last_update_submitted>
  <last_update_submitted_qc>January 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Children's Hospital of Eastern Ontario</investigator_affiliation>
    <investigator_full_name>Dr. Gregory Moore</investigator_full_name>
    <investigator_title>Assistant Professor, Neonatologist</investigator_title>
  </responsible_party>
  <keyword>Infant</keyword>
  <keyword>contamination rates</keyword>
  <keyword>urinary catheterization</keyword>
  <keyword>suprapubic aspiration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Tract Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT01726166
org study id: 2011813-01H
nct id: NCT01726166
lead sponsor: 
collaborator: 
has dmc: No
Urinary tract infection (UTI) is relatively common in infants, with an occurence rate of up
      to 10%.

      Analysis of collected urine for the presence of bacteria or fungus is the only way to make a
      certain UTI diagnosis. Sterile collection of urine can be achieved in newborn infants by
      urinary catheterization (UC) where a catheter is passed through the urethra into the bladder,
      suprapubic aspiration (SPA) where a needle is inserted into the bladder through the abdominal
      wall, or 'clean catch' where urine is collected into a sterile bottle as the baby urinates
      during preparation for UC. The main advantage of SPA is that it bypasses the bacteria that
      normally resides in the urethral opening, thus minimizing the risk of contamination. Some
      studies have suggested that SPA is better than UC for collecting urine in a sterile fashion
      in the neonate due to the difficulty of doing sterile UC in small infants resulting in more
      contaminated samples (also called a false-positive urine culture); there is still no clear
      best choice. UC is commonly used in many Neonatal Intensive Care Units (NICU) as it is
      considered less invasive, can be done by the nursing staff, and generally has a higher chance
      of obtaining urine. SPA is a simple and safe alternative and, although it may be more painful
      than UC, it is performed more quickly. The reported success rate for SPA is variable, but is
      greatly increased when an ultrasound confirms urine in the bladder. The question remains:
      what is the best method for sterile collection of urine in neonates? In this study, the
      investigators will try to answer this question by collecting urine from neonates using either
      ultrasound guided SPA or UC and then comparing the contamination rates between these two
      methods.

      The investigators hypothesize that SPA will result in less contamination of urine samples.

      The investigators also hypothesize that there will be more success in obtaining an adequate
      urine sample (0.5 ml) by SPA, and that there will be no difference in associated complication
      rates between SPA and UC.
See above and other sections.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of contaminated urine samples per SPA and UC
time frame: up to 2 years
description: For SPA samples, urine contamination will be defined as the growth of two or more micro-organisms (any number of colonies per each microorganism) or the growth of Candida species plus growth of any other microorganism.
For UC samples, urine contamination will be defined as the growth of two or more micro-organisms (any number of colonies per each microorganism) or any growth <10^4 colony forming unit(CFU)/ml or the growth of Candida species plus growth of any other microorganism.
The different cut-off used for contamination between UC and SPA samples stems from the fact that the UC procedure is not sterile in the neonatal population.
Note that a bacterial load of <10^3 CFU/mL (e.g. 10^1 or 10^2 CFU/mL) does not grow in the media of either laboratory where our study samples are being cultured.
Further sensitivity analyses will be performed on this outcome measure.
measure: Success rates of obtaining urine by SPA versus UC
time frame: up to 2 years
description: Successful withdrawal of urine is defined as obtaining 0.5ml of urine during an attempt at SPA or UC. This is the quantity required by our laboratory for urine culture.
measure: Time to perform the respective procedures
time frame: up to 2 years
description: Start time will be recorded as initiation of sterile preparation of the skin. Finish time will be recorded as removal of SPA needle or UC catheter. In the event that the catheter is to remain indwelling, finish time will be recorded as the cessation of sample collection for culture
measure: Complication rates of SPA versus UC
time frame: up to 2 years
description: UC complications
macroscopic hematuria within 48 hours after the procedure including the first void.
urinary retention (completely dry diaper with the presence of a distended bladder based on palpation and/or percussion) within the first 4 hours after the procedure.
SPA complications
macroscopic hematuria within 48 hours after the procedure including the first void after the procedure.
bowel perforation defined as the aspiration of stool contents or clinical and radiographic signs present within 4-6 hrs after the procedure.
suprapubic hematoma or abscess occurring within 1 week after the procedure
clinical peritonitis based on the new presence of some or all of the following: fever, tachycardia, absent bowel sounds, abdominal distension, guarding, rigidity or tenderness, and vomiting occuring within 72 hours after the procedure.
measure: Contamination rates of SPA versus UC (excluding clean catch urine)
time frame: up to 2 years
description: Since the investigators will collect a clean catch urine sample if the randomly assigned infant passes urine spontaneously during a UC attempt but not during SPA attempt, the investigators will compare the contamination rates per UC versus SPA with the exclusion of clean catch samples to ensure pure comparison between the two procedures.
measure: Number of attempts per procedure
time frame: up to 2 years
description: For UC: each time a urinary catheter is introduced through the foreskin or the urethral meatus, this will be considered one attempt.
For SPA: each time the skin is punctured by the needle, this will be considered one attempt. This allows for an attempt to include redirection of the needle as long as it remains beneath the skin.
We will be assessing for a procedural learning curve through this outcome measure and the data recorded.
arm group label: Suprapubic Aspiration
arm group type: Active Comparator
description: A trained physician or neonatal nurse practitioner utilizing U/S guidance at the bedside will perform the SPA. An U/S machine is readily available for use in each NICU.
arm group label: Urinary Catheterization
arm group type: Active Comparator
description: The infants will have the procedure done by NICU nurses who have been trained in performing this procedure.
If the randomly assigned infant passes urine spontaneously during a UC attempt after complete perineal cleansing and the urine is collected as a "clean catch" sample, then this infant will be analysed in the assigned group (intention to treat).
intervention type: Procedure
intervention name: Suprapubic Aspiration
description: Pain management will be performed as per our NICU protocols by administering 24% sucrose prior to both procedures to ensure adequate pain control. Additional or different analgesia may be used depending on the patient's specific clinical situation. We will use a chlorhexidine 0.05% with no cetrimide solution as the cleaning solution.
arm group label: Suprapubic Aspiration
intervention type: Procedure
intervention name: Urinary Catheterization
description: Pain management will be performed as per our NICU protocols by administering 24% sucrose prior to both procedures to ensure adequate pain control. Additional or different analgesia may be used depending on the patient's specific clinical situation. We will use a chlorhexidine 0.05% with no cetrimide solution as the cleaning solution.
arm group label: Urinary Catheterization
criteria: 
gender: All
minimum age: 72 Hours
maximum age: 12 Months
healthy volunteers: No
last name: Gregory P Moore, MD
role: Principal Investigator
affiliation: Children's Hospital of Eastern Ontario; Ottawa Hospital; University of Ottawa
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Children's Hospital of Eastern Ontario
investigator full name: Dr. Gregory Moore
investigator title: Assistant Professor, Neonatologist
mesh term: Urinary Tract Infections
sharing ipd: No