<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/NCT01729000</url>
  </required_header>
  <id_info>
    <org_study_id>13971</org_study_id>
    <nct_id>NCT01729000</nct_id>
  </id_info>
  <brief_title>Study to Determine if Gloving in Addition to Hand Hygiene Will Prevent Invasive Infections and Necrotizing Enterocolitis</brief_title>
  <official_title>Gloving and Handwashing to Prevent Invasive Infections in Necrotizing Enterocolitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Virginia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the additional use of gloves (with handwashing before&#xD;
      and after gloving) for all patient contact while infants have intravenous (central or&#xD;
      peripheral) access in a RCT. Preterm infants &lt;1000 grams or less than 29 weeks gestational&#xD;
      age will be randomized after birth to either a handwashing-gloving group or handwashing only&#xD;
      group. The primary outcome will be the incidence of invasive infections (bacterial or fungal)&#xD;
      or necrotizing enterocolitis. Secondary outcomes will include hospital days, preterm&#xD;
      morbidities, mortality, and hospital costs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All infants who had a birth weight of less than or equal to 1000 grams or who were born less&#xD;
      than 29 weeks gestation were eligible for this study. 120 subjects were randomized by day of&#xD;
      life(dol) 8 to one of two study groups--hand hygiene or hand hygiene plus gloving. Study&#xD;
      signs were placed at the bedside and on the isolette sides of each infant with the&#xD;
      appropriate study group guidelines.&#xD;
&#xD;
      The investigators goal was to target the time period these infants are at high-risk for&#xD;
      infection or NEC and its associated mortality. The targeted time was the first 4 weeks of&#xD;
      life or longer while intravenous access is still required. The average age for the first&#xD;
      episode of late-onset sepsis is 22(+/-0.5) days (median: 17 days; 75th percentile: 28 days;&#xD;
      95th percentile: 57 days). The majority of infections that occur after 4 weeks of life are in&#xD;
      patients still requiring IV access (peripheral or central). The presence of an intravenous&#xD;
      line in this group of preterm infants correlates with the presence of risk factors for&#xD;
      infection that would necessitate the need for intravenous access including: parenteral&#xD;
      nutrition, lipid infusion, use of broad spectrum antibiotics, and the intravenous line itself&#xD;
      (if it is a central venous catheter). This strategy focused on the individual infant's risks,&#xD;
      limits exposure to and decreases cost of intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2008</start_date>
  <completion_date type="Actual">June 2011</completion_date>
  <primary_completion_date type="Actual">June 2011</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Invasive Infection</measure>
    <time_frame>Participants will be followed during their NICU hospitalization, an expected average of 3 months</time_frame>
    <description>Invasive infection will be defined as growth of bacteria from culture (blood, urine, CSF, peritoneal) with clinical signs and symptoms of sepsis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Necrotizing enterocolitis (NEC)</measure>
    <time_frame>Participants will be followed for their entire NICU hospitalization, which is an average of 3 months</time_frame>
    <description>NEC will be defined as stage II or greater using Bell's modified criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of stay</measure>
    <time_frame>Participants will be followed for their entire NICU hospitalization, which is an average of 3 months</time_frame>
    <description>Length of stay will be compared in each study arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>Participants will be followed for their entire NICU hospitalization, which is an average of 3 months</time_frame>
    <description>Mortality will be compared in each study arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital cost</measure>
    <time_frame>Participants will be followed for their entire NICU hospitalization, which is an average of 3 months</time_frame>
    <description>Hospital costs will be compared in each study arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Common neonatal morbidities</measure>
    <time_frame>Participants will be followed for their entire NICU hospitalization, which is an average of 3 months</time_frame>
    <description>Common morbidities will be compared in each study arm</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">124</enrollment>
  <condition>Neonatal Infection</condition>
  <condition>Neonatal Necrotizing Enterocolitis</condition>
  <arm_group>
    <arm_group_label>Hand hygiene</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>All staff that have interaction with subjects will perform hand hygiene with all patient contact and before all contact with the intravenous line.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hand hygiene plus gloving</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All staff that have interaction with subjects will perform hand hygiene and wear gloves with all patient contact and before all contact with the intravenous line.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Gloves</intervention_name>
    <description>All staff must wear gloves for subjects that are in the experimental group.</description>
    <arm_group_label>Hand hygiene plus gloving</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Birth weight &lt;1000 grams or gestational age ≤28 weeks&#xD;
&#xD;
          -  less than or equal to 7 days of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  greater than 7 days of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>8 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David A Kaufman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Virginia School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Virginia, Newborn Intensive Care Unit</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22932</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>March 4, 2011</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>November 13, 2012</last_update_submitted>
  <last_update_submitted_qc>November 13, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 20, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Virginia</investigator_affiliation>
    <investigator_full_name>David A Kaufman</investigator_full_name>
    <investigator_title>Prinicpal Investigator</investigator_title>
  </responsible_party>
  <keyword>prematurity</keyword>
  <keyword>infection control</keyword>
  <keyword>necrotizing entercolitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Enterocolitis</mesh_term>
    <mesh_term>Enterocolitis, Necrotizing</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/NCT01729000
org study id: 13971
nct id: NCT01729000
lead sponsor: 
has dmc: No
The purpose of this study is to compare the additional use of gloves (with handwashing before
      and after gloving) for all patient contact while infants have intravenous (central or
      peripheral) access in a RCT. Preterm infants <1000 grams or less than 29 weeks gestational
      age will be randomized after birth to either a handwashing-gloving group or handwashing only
      group. The primary outcome will be the incidence of invasive infections (bacterial or fungal)
      or necrotizing enterocolitis. Secondary outcomes will include hospital days, preterm
      morbidities, mortality, and hospital costs.
All infants who had a birth weight of less than or equal to 1000 grams or who were born less
      than 29 weeks gestation were eligible for this study. 120 subjects were randomized by day of
      life(dol) 8 to one of two study groups--hand hygiene or hand hygiene plus gloving. Study
      signs were placed at the bedside and on the isolette sides of each infant with the
      appropriate study group guidelines.

      The investigators goal was to target the time period these infants are at high-risk for
      infection or NEC and its associated mortality. The targeted time was the first 4 weeks of
      life or longer while intravenous access is still required. The average age for the first
      episode of late-onset sepsis is 22(+/-0.5) days (median: 17 days; 75th percentile: 28 days;
      95th percentile: 57 days). The majority of infections that occur after 4 weeks of life are in
      patients still requiring IV access (peripheral or central). The presence of an intravenous
      line in this group of preterm infants correlates with the presence of risk factors for
      infection that would necessitate the need for intravenous access including: parenteral
      nutrition, lipid infusion, use of broad spectrum antibiotics, and the intravenous line itself
      (if it is a central venous catheter). This strategy focused on the individual infant's risks,
      limits exposure to and decreases cost of intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Invasive Infection
time frame: Participants will be followed during their NICU hospitalization, an expected average of 3 months
description: Invasive infection will be defined as growth of bacteria from culture (blood, urine, CSF, peritoneal) with clinical signs and symptoms of sepsis
measure: Necrotizing enterocolitis (NEC)
time frame: Participants will be followed for their entire NICU hospitalization, which is an average of 3 months
description: NEC will be defined as stage II or greater using Bell's modified criteria
measure: Length of stay
time frame: Participants will be followed for their entire NICU hospitalization, which is an average of 3 months
description: Length of stay will be compared in each study arm
measure: Mortality
time frame: Participants will be followed for their entire NICU hospitalization, which is an average of 3 months
description: Mortality will be compared in each study arm
measure: Hospital cost
time frame: Participants will be followed for their entire NICU hospitalization, which is an average of 3 months
description: Hospital costs will be compared in each study arm
measure: Common neonatal morbidities
time frame: Participants will be followed for their entire NICU hospitalization, which is an average of 3 months
description: Common morbidities will be compared in each study arm
arm group label: Hand hygiene
arm group type: No Intervention
description: All staff that have interaction with subjects will perform hand hygiene with all patient contact and before all contact with the intravenous line.
arm group label: Hand hygiene plus gloving
arm group type: Experimental
description: All staff that have interaction with subjects will perform hand hygiene and wear gloves with all patient contact and before all contact with the intravenous line.
intervention type: Other
intervention name: Gloves
description: All staff must wear gloves for subjects that are in the experimental group.
arm group label: Hand hygiene plus gloving
criteria: 
gender: All
minimum age: N/A
maximum age: 8 Days
healthy volunteers: No
last name: David A Kaufman, MD
role: Principal Investigator
affiliation: University of Virginia School of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Virginia
investigator full name: David A Kaufman
investigator title: Prinicpal Investigator
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Enterocolitis
mesh term: Enterocolitis, Necrotizing