xml: <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/NCT06000761</url>
    </required_header>
    <id_info>
      <org_study_id>202101340</org_study_id>
      <nct_id>NCT06000761</nct_id>
    </id_info>
    <brief_title>Frequent Standardized Oral Care Using Human Milk in the Neonatal Intensive Care Unit</brief_title>
    <official_title>Frequent Standardized Oral Care Using Human Milk to Prevent Oral Dysbiosis and Improve Health Outcomes in Premature Infants in the Neonatal Intensive Care Unit</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Florida</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>The Gerber Foundation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Florida</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>
        Premature infants are susceptible to complications related to infrequent and non-standardized&#xD;
        oral care. Although the benefits of frequent standardized oral care are known to reduce oral&#xD;
        dysbiosis (increased level of potentially pathogenic bacteria) and its associated&#xD;
        complications in critically ill adults leading to established evidence-based guidelines, no&#xD;
        such information exists for VLBW infants. The proposed study will prospectively follow 168&#xD;
        VLBW infants for 4 weeks following birth.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Premature very low birth weight (VLBW) infants are susceptible to complications related to&#xD;
        infrequent and non-standardized oral care. Although the benefits of frequent standardized&#xD;
        oral care are known to reduce oral dysbiosis (increased level of potentially pathogenic&#xD;
        bacteria) and its associated complications in critically ill adults leading to established&#xD;
        evidence-based guidelines, no such information exists for VLBW infants. Premature VLBW&#xD;
        infants are highly susceptible to costly, life threatening and potentially preventable&#xD;
        morbidities, such as ventilator associated pneumonia (VAP), bronchopulmonary dysplasia (BPD;&#xD;
        oxygen requirement at 28 days of life) and need for prolonged respiratory support which&#xD;
        require additional treatments, increase cost of care, and can lead to chronic illness,&#xD;
        re-hospitalization, and developmental delay. A dearth of information exists regarding oral&#xD;
        care in VLBW infants, and no such guidelines exist for infants admitted to the neonatal&#xD;
        intensive care unit (NICU) which may negatively affect their health. Thus, research regarding&#xD;
        the effect of frequent, standardized oral care on the health of VLBW infants is essential to&#xD;
        develop guidelines thus potentially improving the health of this vulnerable population. If&#xD;
        successful, this research could change practice in NICUs across the nation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 23, 2023</start_date>
    <completion_date type="Anticipated">December 20, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 23, 2026</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>Sequential Assignment</intervention_model>
      <intervention_model_description>The proposed study will prospectively follow 168 VLBW infants and 168 mothers (dyad) for 4 weeks following birth. Infants will be randomized into 1 of 3 groups. Standardized oral care will be performed every 3-4 hours using human milk (Group 1), every 3-4 hours using sterile water (Group 2) or every 12 hours using sterile water (Group 3).</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>All de-identified saliva and breast milk samples will be conducted at a UF lab outside of Shands. ETT culture samples will also be de-identified before sending to Shands CoreLab. Investigators determining clinical outcomes will be blinded to group allocation</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Number of participants with oral microbiome dysbiosis.</measure>
      <time_frame>0-28 days</time_frame>
      <description>Oral samples will be obtained weekly and the microbiome analyzed using rRNA 16s sequencing</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of participants with ventilator associated pneumonia</measure>
      <time_frame>0-28 days</time_frame>
      <description>Evidence of ventilator pneumonia will be assessed weekly over the first 4 weeks of life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with bronchopulmonary dysplasia</measure>
      <time_frame>0-60 days</time_frame>
      <description>Evidence of bronchopulmonary dysplasia will be assessed weekly over the first 60 days of life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of days requiring respiratory support</measure>
      <time_frame>0-60 days</time_frame>
      <description>Days the infant was on any type of respiratory support will be assessed daily for the first 60 days of life</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">218</enrollment>
    <condition>Ventilator Associated Pneumonia</condition>
    <condition>Bronchopulmonary Dysplasia</condition>
    <condition>Respiratory Disease</condition>
    <arm_group>
      <arm_group_label>Group 1</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Standardized oral care performed every 3-4 hours using human milk, donor or breast milk.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Standardized oral care performed every 3-4 hours using sterile water.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 3</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Standardized oral care performed every 12 hours using sterile water.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Standardized oral Care</intervention_name>
      <description>One sponge-tipped swab, saturated with sterile water or human milk, will used clean the oral cavity with 15 seconds each area. Surfaces include all 4 quadrants of the gum surface and upper posterior part of the oropharynx. A second swab, with sterile water or milk will be used on the ventral and posterior surfaces of the tongue. A third swab, saturated with sterile water or human milk, will be used to clean the outer surface of any dwelling oral tubes (endotracheal tube, NAVA or feeding tube). Lips will be cleaned with a sterile gauze saturated with sterile water or human milk. Oral cavity will be suctioned as needed with an oral suction devise to remove secretions.</description>
      <arm_group_label>Group 1</arm_group_label>
      <arm_group_label>Group 2</arm_group_label>
      <arm_group_label>Group 3</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion:&#xD;
  &#xD;
            -  Mother ≥18 years of age&#xD;
  &#xD;
            -  ≤ 30 weeks gestation&#xD;
  &#xD;
            -  Born weighing ≤ 1500 grams&#xD;
  &#xD;
          Exclusion:&#xD;
  &#xD;
            -  Congenital anomalies of the face, lungs, or gastrointestinal system&#xD;
  &#xD;
            -  Not expected to live &gt; 7 days following delivery.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Hour</minimum_age>
      <maximum_age>3 Days</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Leslie Parker, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Florida</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Leslie A Parker, PhD, APRN</last_name>
      <phone>352-273-6384</phone>
      <email>parkela@ufl.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida</name>
        <address>
          <city>Gainesville</city>
          <state>Florida</state>
          <zip>32504</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</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>Pneumonia, Ventilator-Associated</mesh_term>
      <mesh_term>Respiratory Tract Diseases</mesh_term>
      <mesh_term>Respiration Disorders</mesh_term>
      <mesh_term>Bronchopulmonary Dysplasia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>August 23, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT06000761/Prot_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06000761
  org study id: 202101340
  nct id: NCT06000761
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Premature infants are susceptible to complications related to infrequent and non-standardized
        oral care. Although the benefits of frequent standardized oral care are known to reduce oral
        dysbiosis (increased level of potentially pathogenic bacteria) and its associated
        complications in critically ill adults leading to established evidence-based guidelines, no
        such information exists for VLBW infants. The proposed study will prospectively follow 168
        VLBW infants for 4 weeks following birth.
  Premature very low birth weight (VLBW) infants are susceptible to complications related to
        infrequent and non-standardized oral care. Although the benefits of frequent standardized
        oral care are known to reduce oral dysbiosis (increased level of potentially pathogenic
        bacteria) and its associated complications in critically ill adults leading to established
        evidence-based guidelines, no such information exists for VLBW infants. Premature VLBW
        infants are highly susceptible to costly, life threatening and potentially preventable
        morbidities, such as ventilator associated pneumonia (VAP), bronchopulmonary dysplasia (BPD;
        oxygen requirement at 28 days of life) and need for prolonged respiratory support which
        require additional treatments, increase cost of care, and can lead to chronic illness,
        re-hospitalization, and developmental delay. A dearth of information exists regarding oral
        care in VLBW infants, and no such guidelines exist for infants admitted to the neonatal
        intensive care unit (NICU) which may negatively affect their health. Thus, research regarding
        the effect of frequent, standardized oral care on the health of VLBW infants is essential to
        develop guidelines thus potentially improving the health of this vulnerable population. If
        successful, this research could change practice in NICUs across the nation.
  allocation: Randomized
  intervention model: Sequential Assignment
  intervention model description: The proposed study will prospectively follow 168 VLBW infants and 168 mothers (dyad) for 4 weeks following birth. Infants will be randomized into 1 of 3 groups. Standardized oral care will be performed every 3-4 hours using human milk (Group 1), every 3-4 hours using sterile water (Group 2) or every 12 hours using sterile water (Group 3).
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  masking description: All de-identified saliva and breast milk samples will be conducted at a UF lab outside of Shands. ETT culture samples will also be de-identified before sending to Shands CoreLab. Investigators determining clinical outcomes will be blinded to group allocation
  measure: Number of participants with oral microbiome dysbiosis.
  time frame: 0-28 days
  description: Oral samples will be obtained weekly and the microbiome analyzed using rRNA 16s sequencing
  measure: Number of participants with ventilator associated pneumonia
  time frame: 0-28 days
  description: Evidence of ventilator pneumonia will be assessed weekly over the first 4 weeks of life
  measure: Number of participants with bronchopulmonary dysplasia
  time frame: 0-60 days
  description: Evidence of bronchopulmonary dysplasia will be assessed weekly over the first 60 days of life
  measure: Number of days requiring respiratory support
  time frame: 0-60 days
  description: Days the infant was on any type of respiratory support will be assessed daily for the first 60 days of life
  arm group label: Group 1
  arm group type: Active Comparator
  description: Standardized oral care performed every 3-4 hours using human milk, donor or breast milk.
  arm group label: Group 2
  arm group type: Active Comparator
  description: Standardized oral care performed every 3-4 hours using sterile water.
  arm group label: Group 3
  arm group type: Active Comparator
  description: Standardized oral care performed every 12 hours using sterile water.
  intervention type: Procedure
  intervention name: Standardized oral Care
  description: One sponge-tipped swab, saturated with sterile water or human milk, will used clean the oral cavity with 15 seconds each area. Surfaces include all 4 quadrants of the gum surface and upper posterior part of the oropharynx. A second swab, with sterile water or milk will be used on the ventral and posterior surfaces of the tongue. A third swab, saturated with sterile water or human milk, will be used to clean the outer surface of any dwelling oral tubes (endotracheal tube, NAVA or feeding tube). Lips will be cleaned with a sterile gauze saturated with sterile water or human milk. Oral cavity will be suctioned as needed with an oral suction devise to remove secretions.
  arm group label: Group 1
  arm group label: Group 2
  arm group label: Group 3
  criteria: 
  gender: All
  minimum age: 1 Hour
  maximum age: 3 Days
  healthy volunteers: No
  last name: Leslie Parker, PHD
  role: Principal Investigator
  affiliation: University of Florida
  last name: Leslie A Parker, PhD, APRN
  phone: 352-273-6384
  email: parkela@ufl.edu
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Pneumonia, Ventilator-Associated
  mesh term: Respiratory Tract Diseases
  mesh term: Respiration Disorders
  mesh term: Bronchopulmonary Dysplasia
  sharing ipd: No
  provided document: 