<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/NCT04453969</url>
  </required_header>
  <id_info>
    <org_study_id>39373-a</org_study_id>
    <nct_id>NCT04453969</nct_id>
  </id_info>
  <brief_title>Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1a</brief_title>
  <official_title>Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1a</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Deborah O'Connor</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sinai Health System</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Hospital for Sick Children</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Canadian Paediatric Society recommends breastfeeding during COVID-19 infection. Human&#xD;
      milk is the best form of infant nutrition providing significant protection against many&#xD;
      illnesses for term and preterm infants. The impact of a pandemic on breastfeeding is unknown.&#xD;
      This study seeks to address this public health issue. Breastmilk will be collected from&#xD;
      mothers positive for COVID-19. Samples will be analyzed for the COVID-19 virus specific&#xD;
      nucleic acid and antibody in real-time and results will be immediately disseminated to&#xD;
      relevant organizations to inform local, national and international guidelines surrounding&#xD;
      breastfeeding to protect the health of infants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 24, 2020</start_date>
  <completion_date type="Anticipated">April 27, 2023</completion_date>
  <primary_completion_date type="Anticipated">April 27, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of SARS-CoV-2 in breastmilk</measure>
    <time_frame>2-6 months</time_frame>
    <description>To describe the presence of SARS-CoV-2 nucleic acid in human milk samples collected from mothers positive for COVID-19</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SARS-CoV-2 antibody in breastmilk</measure>
    <time_frame>2-6 months</time_frame>
    <description>To describe the presence of SARS-CoV-2 antibody in human milk samples collected from mothers positive for COVID-19</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">59</enrollment>
  <condition>SARS-CoV2</condition>
  <condition>Breastmilk</condition>
  <arm_group>
    <arm_group_label>Breastfeeding mothers positive for COVID-19</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>COVID-19</intervention_name>
    <description>Exposure of interest for this observational study is current COVID-19 positive status or COVID-19 positive status during pregnancy</description>
    <arm_group_label>Breastfeeding mothers positive for COVID-19</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Community sample&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Current COVID-19 positive status or COVID-19 positive status during pregnancy&#xD;
&#xD;
          -  Intent to breastfeed or currently breastfeeding&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sinai Health System</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Toronto</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5S 1A8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>October 25, 2022</last_update_submitted>
  <last_update_submitted_qc>October 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>The Hospital for Sick Children</investigator_affiliation>
    <investigator_full_name>Deborah O'Connor</investigator_full_name>
    <investigator_title>Scientist</investigator_title>
  </responsible_party>
  <!-- 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/NCT04453969
org study id: 39373-a
nct id: NCT04453969
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The Canadian Paediatric Society recommends breastfeeding during COVID-19 infection. Human
      milk is the best form of infant nutrition providing significant protection against many
      illnesses for term and preterm infants. The impact of a pandemic on breastfeeding is unknown.
      This study seeks to address this public health issue. Breastmilk will be collected from
      mothers positive for COVID-19. Samples will be analyzed for the COVID-19 virus specific
      nucleic acid and antibody in real-time and results will be immediately disseminated to
      relevant organizations to inform local, national and international guidelines surrounding
      breastfeeding to protect the health of infants.
observational model: Cohort
time perspective: Prospective
measure: Presence of SARS-CoV-2 in breastmilk
time frame: 2-6 months
description: To describe the presence of SARS-CoV-2 nucleic acid in human milk samples collected from mothers positive for COVID-19
measure: SARS-CoV-2 antibody in breastmilk
time frame: 2-6 months
description: To describe the presence of SARS-CoV-2 antibody in human milk samples collected from mothers positive for COVID-19
arm group label: Breastfeeding mothers positive for COVID-19
intervention type: Other
intervention name: COVID-19
description: Exposure of interest for this observational study is current COVID-19 positive status or COVID-19 positive status during pregnancy
arm group label: Breastfeeding mothers positive for COVID-19
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: Canada
responsible party type: Sponsor-Investigator
investigator affiliation: The Hospital for Sick Children
investigator full name: Deborah O'Connor
investigator title: Scientist