<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/NCT01678638</url>
  </required_header>
  <id_info>
    <org_study_id>11-225-01</org_study_id>
    <nct_id>NCT01678638</nct_id>
  </id_info>
  <brief_title>Timing of Inguinal Hernia Repair in Premature Infants</brief_title>
  <official_title>Timing of Inguinal Hernia Repair in Premature Infants: A Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Vanderbilt University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether early (before NICU discharge) or late&#xD;
      (55-60 weeks post-menstrual age) inguinal hernia repair is safer for premature infants who&#xD;
      have an inguinal hernia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized clinical trial comparing early versus late repair in premature infants&#xD;
      with an inguinal hernia (IH) to determine which approach may be safer. Safety in this trial&#xD;
      is defined as the freedom from significant adverse events, a reduction in hospital days&#xD;
      during the study period, and normal neurodevelopmental testing at 2 years. Costs of each&#xD;
      treatment strategy are also important and are being evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Anticipated">July 2023</completion_date>
  <primary_completion_date type="Actual">April 2023</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Significant adverse event (SAE) rate</measure>
    <time_frame>9 months beyond NICU discharge</time_frame>
    <description>Specific significant adverse events that are either treatment related or hernia related have been defined a priori and will be assessed in both groups from randomization until 9 months after NICU discharge.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of hospital days</measure>
    <time_frame>From randomization until 9 months post NICU discharge</time_frame>
    <description>Total number of hospital days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital costs</measure>
    <time_frame>Enrollment through 9 months after NICU discharge</time_frame>
    <description>Departmental level costs at each participating institution will be determined for care that occurs from randomization until 9 months post NICU discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bayley Scales of Infant Development, 3rd Edition</measure>
    <time_frame>22-26 months corrected age</time_frame>
    <description>Mean BSID scores; primarily cognitive domain</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Inguinal Hernia</condition>
  <condition>Premature Birth of Newborn</condition>
  <arm_group>
    <arm_group_label>Early inguinal hernia (IH) repair</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>IH repair before NICU discharge</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Late inguinal hernia (IH) repair</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>IH repair as outpatient at approximately 55-60 weeks post-menstrual age</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>IH repair before NICU discharge</intervention_name>
    <description>The IH repair is performed prior to NICU discharge (within 1-2 weeks of enrollment and randomization)</description>
    <arm_group_label>Early inguinal hernia (IH) repair</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>IH repair at 55-60 weeks post-menstrual age</intervention_name>
    <description>The IH repair will be performed as an outpatient between approximately 55-60 weeks post-menstrual age.</description>
    <arm_group_label>Late inguinal hernia (IH) repair</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infant with estimated gestational age at birth of &lt; 37 weeks, 0 days&#xD;
&#xD;
          -  In a NICU at participating site&#xD;
&#xD;
          -  Diagnosed with an IH per the pediatric surgery team&#xD;
&#xD;
          -  Parents and providers willing to randomize the infant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infant is undergoing another operative procedure and IH repair is planned as a&#xD;
             secondary procedure (e.g. fundoplication or G tube is planned, and IH repair is&#xD;
             considered a secondary procedure)&#xD;
&#xD;
          -  Known major congenital anomaly that impacts neurodevelopmental outcome or chromosomal&#xD;
             abnormality&#xD;
&#xD;
          -  Family unable to return for follow up and later IH repair; or likely unable to monitor&#xD;
             IH as outpatient&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>37 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin L Blakely, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jon E Tyson, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas Health Science Center at Houston; Children's Memorial Hermann Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham School of Medicine; Children's Hospital of Alabama</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Arkansas for Medical Sciences; Arkansas Children's Hospital</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern California Permanente Group</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, Los Angeles David Geffen School of Medicine; Mattel Children's &amp; LA Biomed</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley Children's Hospital</name>
      <address>
        <city>Madera</city>
        <state>California</state>
        <zip>93636</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Naval Medical Center San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCSD Rady Children's Hospital</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connecticut Children's Medical Center</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UF Health Shands Children's Hospital</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins All Children's Hospital</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota Medical School; Amplatz Children's Hospital</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SSM Health Cardinal Glennon Children's Hospital</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine in St. Louis; St. Louis Children's Hospital</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital &amp; Medical Center of Omaha</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albany Medical Center</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oishei Children's Hospital of Buffalo</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Irving Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cohen Children's Medical Center</name>
      <address>
        <city>Queens</city>
        <state>New York</state>
        <zip>11040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center; Duke Children's Hospital and Health Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akron Children's Hospital</name>
      <address>
        <city>Akron</city>
        <state>Ohio</state>
        <zip>44308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University College of Medicine; Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dayton Children's Hospital</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OHSU Doernbecher Children's Hospital</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women &amp; Infants Hospital of Rhode Island</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital at Erlanger UT Chattanooga</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Tennessee Health Science Center; Le Bonheur Children's Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monroe Carell Jr. Children's Hospital at Vanderbilt</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas, Southwestern Medical Center; Children's Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine; Texas Children's Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center at Houston; Children's Memorial Hermann Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Primary Children's Hospital University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UVA Children's Hospital</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University Medical Center; Children's Hospital of Richmond</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23284</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington School of Medicine; Seattle Children's Hospital</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin; Children's Hospital of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>May 12, 2023</last_update_submitted>
  <last_update_submitted_qc>May 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Martin Blakely</investigator_full_name>
    <investigator_title>Associate Professor of Pediatric Surgery and Pediatrics</investigator_title>
  </responsible_party>
  <keyword>inguinal hernia</keyword>
  <keyword>premature infants</keyword>
  <keyword>anesthesia safety</keyword>
  <keyword>neurodevelopmental outcome</keyword>
  <keyword>preterm infants</keyword>
  <keyword>neonatal prematurity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Inguinal</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/NCT01678638
org study id: 11-225-01
nct id: NCT01678638
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine whether early (before NICU discharge) or late
      (55-60 weeks post-menstrual age) inguinal hernia repair is safer for premature infants who
      have an inguinal hernia.
This is a randomized clinical trial comparing early versus late repair in premature infants
      with an inguinal hernia (IH) to determine which approach may be safer. Safety in this trial
      is defined as the freedom from significant adverse events, a reduction in hospital days
      during the study period, and normal neurodevelopmental testing at 2 years. Costs of each
      treatment strategy are also important and are being evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Significant adverse event (SAE) rate
time frame: 9 months beyond NICU discharge
description: Specific significant adverse events that are either treatment related or hernia related have been defined a priori and will be assessed in both groups from randomization until 9 months after NICU discharge.
measure: Number of hospital days
time frame: From randomization until 9 months post NICU discharge
description: Total number of hospital days
measure: Hospital costs
time frame: Enrollment through 9 months after NICU discharge
description: Departmental level costs at each participating institution will be determined for care that occurs from randomization until 9 months post NICU discharge.
measure: Bayley Scales of Infant Development, 3rd Edition
time frame: 22-26 months corrected age
description: Mean BSID scores; primarily cognitive domain
arm group label: Early inguinal hernia (IH) repair
arm group type: Active Comparator
description: IH repair before NICU discharge
arm group label: Late inguinal hernia (IH) repair
arm group type: Active Comparator
description: IH repair as outpatient at approximately 55-60 weeks post-menstrual age
intervention type: Procedure
intervention name: IH repair before NICU discharge
description: The IH repair is performed prior to NICU discharge (within 1-2 weeks of enrollment and randomization)
arm group label: Early inguinal hernia (IH) repair
intervention type: Procedure
intervention name: IH repair at 55-60 weeks post-menstrual age
description: The IH repair will be performed as an outpatient between approximately 55-60 weeks post-menstrual age.
arm group label: Late inguinal hernia (IH) repair
criteria: 
gender: All
minimum age: N/A
maximum age: 37 Weeks
healthy volunteers: No
last name: Martin L Blakely, MD, MS
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
last name: Jon E Tyson, MD, MPH
role: Principal Investigator
affiliation: University of Texas Health Science Center at Houston; Children's Memorial Hermann Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Martin Blakely
investigator title: Associate Professor of Pediatric Surgery and Pediatrics
mesh term: Premature Birth
mesh term: Hernia
mesh term: Hernia, Inguinal
sharing ipd: No