<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/NCT01688440</url>
  </required_header>
  <id_info>
    <org_study_id>05.018</org_study_id>
    <nct_id>NCT01688440</nct_id>
  </id_info>
  <brief_title>ETCare: Safety and Preliminary Efficacy Trial</brief_title>
  <official_title>&quot;ETCare&quot;: A Phase II, Safety and Preliminary Efficacy Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intermountain Health Care, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Deseret Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Intermountain Health Care, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      When babies are sick, or are born prematurely, they sometimes need an endotracheal (ET) tube&#xD;
      to assist their breathing and/or a nasal canula. The investigators must periodically irrigate&#xD;
      the ET tube to prevent them from being plugged up by secretions. The investigators also, due&#xD;
      to the drying effects of nasal canula, periodically moisten the nasal passages of babies.&#xD;
      Presently 0.9% saline is the solution being used for moistening of the ET tube, nose, as well&#xD;
      as oral cares will infant is not eating. However, scientists have recently learned that&#xD;
      saline can destroy the body's natural antibacterial properties in the windpipe, nose, and&#xD;
      mouth.&#xD;
&#xD;
      The investigators have developed a new solution to be used in place of saline for&#xD;
      endotracheal (ET), nasal, and oral cares. The investigators' new solution is patterned after&#xD;
      the natural fluid in the windpipe, nose, and mouth.&#xD;
&#xD;
      Study Hypothesis:&#xD;
&#xD;
        1. Patients who receive ETCare will have no increase in adverse events related to its&#xD;
           administration, compared with 0.9% saline.&#xD;
&#xD;
        2. Patients who receive ETCare will have a lower proportion of tracheal aspirates where&#xD;
           pathogens are reported.&#xD;
&#xD;
        3. Patients who receive ETCare will have a lower proportion of tracheal aspirates where&#xD;
           leukocytes are reported.&#xD;
&#xD;
        4. Patients who receive ETCare will have fewer (risk-adjusted) days of supplemental oxygen.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Normal saline (0.9% sodium chloride) is used by virtually all neonatal intensive care units&#xD;
      to periodically irrigate the endotracheal tube of neonates who require mechanical&#xD;
      ventilation. This practice is intended to reduce the risk that thick secretions will occlude&#xD;
      the endotracheal tube. Normal saline is also occasionally used to periodically clear the&#xD;
      nasal passages of neonates on nasal CPAP or nasal canula oxygen. It is also occasionally used&#xD;
      as a means of periodically moistening the mouth of neonates who have an endotracheal tube in&#xD;
      place, because the tube prevents lip apposition and results in a dry mouth.&#xD;
&#xD;
      The problem with the current method of using normal saline for periodic endotracheal, nasal,&#xD;
      and/or oral care is that high concentrations of sodium and chloride have recently been found&#xD;
      to rapidly and completely inactivate the natural antimicrobial properties of tracheal&#xD;
      effluent, nasal secretions, and saliva. Tracheal secretions, nasal secretions, and saliva&#xD;
      contain potent antibacterial substances. One such that was recently described is a 37 amino&#xD;
      acid peptide with widespread antimicrobial properties, termed &quot;LL-37&quot;. It has recently been&#xD;
      shown that 0.9% saline inactivates the antimicrobial properties of LL-37 and significantly&#xD;
      damages the overall antibacterial actions of tracheal secretions, nasal secretions, and&#xD;
      saliva. Further research has shown that the high sodium and chloride content of saliva of&#xD;
      patients with cystic fibrosis inactivates the antimicrobial properties, thus partly&#xD;
      explaining the high incidence of airway infections in these patients. Moreover, a family with&#xD;
      deficient LL-37 has been described in Sweden, and these individual all have chronic&#xD;
      gingivostomatitis and airway infections. Therefore, our current practice of instilling 0.9%&#xD;
      sodium chloride likely inactivates the major innate anti-microbial defense system of the&#xD;
      upper airway. Perhaps reducing immune capacity in the upper airway with this practice&#xD;
      unwittingly contributes to the high incidence of upper airway infections among intubated&#xD;
      neonates.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2005</start_date>
  <completion_date type="Actual">September 2005</completion_date>
  <primary_completion_date type="Actual">September 2005</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of adverse events related to administration.</measure>
    <time_frame>To discharge home (about one month).</time_frame>
    <description>Renal hematological and hepatic function.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility and immediate intolerance</measure>
    <time_frame>Day of administration (one day)</time_frame>
    <description>Desaturation, bradycardia, tachydardia, hypotension, or hypertension or skin rashes.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Respiratory Distress Syndrome, Newborn</condition>
  <arm_group>
    <arm_group_label>#1 Respiratory Care Solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low sodium physiologically based airway care solution.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>#1 Respiratory Care Solution</intervention_name>
    <description>Respiratory care solution.</description>
    <arm_group_label>#1 Respiratory Care Solution</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be a patient in the NICU of either McKay-Dee Hospital or LDS Hospital.&#xD;
&#xD;
          -  Be &lt;24 hrs old at the time of study entry.&#xD;
&#xD;
          -  Have an endotracheal tube in place.&#xD;
&#xD;
          -  Be expected, by declaration of the attending neonatologist, to have an endotracheal&#xD;
             tube for at least the next 48 hrs.&#xD;
&#xD;
          -  Have the informed consent document signed by the parent or responsible guardian&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  They have what the attending neonatologist judges to be a &quot;lethal&quot; congenital&#xD;
             abnormality.&#xD;
&#xD;
          -  They have a condition that is likely (by judgment of the attending neonatologist) to&#xD;
             require transfer to Primary Children's Medical Center before the endotracheal tube has&#xD;
             been electively removed.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert D. Christensen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Interountain Healthcare</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>McKay-Dee Hospital Center</name>
      <address>
        <city>Ogden</city>
        <state>Utah</state>
        <zip>84403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LDS Hospital Center</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>May 12, 2008</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>September 18, 2012</last_update_submitted>
  <last_update_submitted_qc>September 18, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Intermountain Health Care, Inc.</investigator_affiliation>
    <investigator_full_name>Robert D. Christensen, MD</investigator_full_name>
    <investigator_title>Director, Neonatology Research</investigator_title>
  </responsible_party>
  <keyword>Endotracheal Cares</keyword>
  <keyword>Neonate</keyword>
  <keyword>TAC's</keyword>
  <keyword>Endotracheal Suctioning</keyword>
  <keyword>Tracheal Aspirate Culture</keyword>
  <keyword>Oral Cares</keyword>
  <keyword>Neonate oxygen Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</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/NCT01688440
org study id: 05.018
nct id: NCT01688440
lead sponsor: 
collaborator: 
has dmc: No
When babies are sick, or are born prematurely, they sometimes need an endotracheal (ET) tube
      to assist their breathing and/or a nasal canula. The investigators must periodically irrigate
      the ET tube to prevent them from being plugged up by secretions. The investigators also, due
      to the drying effects of nasal canula, periodically moisten the nasal passages of babies.
      Presently 0.9% saline is the solution being used for moistening of the ET tube, nose, as well
      as oral cares will infant is not eating. However, scientists have recently learned that
      saline can destroy the body's natural antibacterial properties in the windpipe, nose, and
      mouth.

      The investigators have developed a new solution to be used in place of saline for
      endotracheal (ET), nasal, and oral cares. The investigators' new solution is patterned after
      the natural fluid in the windpipe, nose, and mouth.

      Study Hypothesis:

        1. Patients who receive ETCare will have no increase in adverse events related to its
           administration, compared with 0.9% saline.

        2. Patients who receive ETCare will have a lower proportion of tracheal aspirates where
           pathogens are reported.

        3. Patients who receive ETCare will have a lower proportion of tracheal aspirates where
           leukocytes are reported.

        4. Patients who receive ETCare will have fewer (risk-adjusted) days of supplemental oxygen.
Normal saline (0.9% sodium chloride) is used by virtually all neonatal intensive care units
      to periodically irrigate the endotracheal tube of neonates who require mechanical
      ventilation. This practice is intended to reduce the risk that thick secretions will occlude
      the endotracheal tube. Normal saline is also occasionally used to periodically clear the
      nasal passages of neonates on nasal CPAP or nasal canula oxygen. It is also occasionally used
      as a means of periodically moistening the mouth of neonates who have an endotracheal tube in
      place, because the tube prevents lip apposition and results in a dry mouth.

      The problem with the current method of using normal saline for periodic endotracheal, nasal,
      and/or oral care is that high concentrations of sodium and chloride have recently been found
      to rapidly and completely inactivate the natural antimicrobial properties of tracheal
      effluent, nasal secretions, and saliva. Tracheal secretions, nasal secretions, and saliva
      contain potent antibacterial substances. One such that was recently described is a 37 amino
      acid peptide with widespread antimicrobial properties, termed "LL-37". It has recently been
      shown that 0.9% saline inactivates the antimicrobial properties of LL-37 and significantly
      damages the overall antibacterial actions of tracheal secretions, nasal secretions, and
      saliva. Further research has shown that the high sodium and chloride content of saliva of
      patients with cystic fibrosis inactivates the antimicrobial properties, thus partly
      explaining the high incidence of airway infections in these patients. Moreover, a family with
      deficient LL-37 has been described in Sweden, and these individual all have chronic
      gingivostomatitis and airway infections. Therefore, our current practice of instilling 0.9%
      sodium chloride likely inactivates the major innate anti-microbial defense system of the
      upper airway. Perhaps reducing immune capacity in the upper airway with this practice
      unwittingly contributes to the high incidence of upper airway infections among intubated
      neonates.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: The incidence of adverse events related to administration.
time frame: To discharge home (about one month).
description: Renal hematological and hepatic function.
measure: Feasibility and immediate intolerance
time frame: Day of administration (one day)
description: Desaturation, bradycardia, tachydardia, hypotension, or hypertension or skin rashes.
arm group label: #1 Respiratory Care Solution
arm group type: Experimental
description: Low sodium physiologically based airway care solution.
intervention type: Other
intervention name: #1 Respiratory Care Solution
description: Respiratory care solution.
arm group label: #1 Respiratory Care Solution
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Robert D. Christensen, MD
role: Principal Investigator
affiliation: Interountain Healthcare
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Intermountain Health Care, Inc.
investigator full name: Robert D. Christensen, MD
investigator title: Director, Neonatology Research
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn