<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/NCT04453982</url>
  </required_header>
  <id_info>
    <org_study_id>39373-b</org_study_id>
    <nct_id>NCT04453982</nct_id>
  </id_info>
  <brief_title>Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1b</brief_title>
  <official_title>Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1b</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. When mothers of hospitalized infants are unable to&#xD;
      supply their milk, the recommended supplement is human donor milk. The impact of a pandemic&#xD;
      on human milk banking is unknown. This study seeks to address this public health issue. Donor&#xD;
      milk will be collected from the Rogers Hixon Ontario Human Milk Bank at Sinai Health System&#xD;
      in Toronto. Samples will be analyzed for the COVID-19 virus specific nucleic acid and&#xD;
      antibody in real-time and results will be immediately disseminated to relevant organizations&#xD;
      to inform local, national and international guidelines surrounding donor milk banking to&#xD;
      protect the health of infants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 21, 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>Prevalence of SARS-CoV-2 in breastmilk</measure>
    <time_frame>2 months</time_frame>
    <description>To describe the prevalence of human milk donations received at the Ontario Human Milk Bank that test positive for SARS-CoV-2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of SARS-CoV-2 antibody in breastmilk</measure>
    <time_frame>2 months</time_frame>
    <description>To describe the prevalence of human milk donations received at the Ontario Human Milk Bank with antibodies for SARS-CoV-2</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">384</enrollment>
  <condition>Sars-CoV2</condition>
  <condition>Breastmilk</condition>
  <arm_group>
    <arm_group_label>Human milk donors</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Human milk donors</intervention_name>
    <description>Human milk donors for the Rogers Hixon Ontario Human Milk Bank</description>
    <arm_group_label>Human milk donors</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;
        - Human milk donor for the Rogers Hixon Ontario Human Milk Bank&#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_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/NCT04453982
org study id: 39373-b
nct id: NCT04453982
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. When mothers of hospitalized infants are unable to
      supply their milk, the recommended supplement is human donor milk. The impact of a pandemic
      on human milk banking is unknown. This study seeks to address this public health issue. Donor
      milk will be collected from the Rogers Hixon Ontario Human Milk Bank at Sinai Health System
      in Toronto. 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 donor milk banking to
      protect the health of infants.
observational model: Cohort
time perspective: Prospective
measure: Prevalence of SARS-CoV-2 in breastmilk
time frame: 2 months
description: To describe the prevalence of human milk donations received at the Ontario Human Milk Bank that test positive for SARS-CoV-2
measure: Prevalence of SARS-CoV-2 antibody in breastmilk
time frame: 2 months
description: To describe the prevalence of human milk donations received at the Ontario Human Milk Bank with antibodies for SARS-CoV-2
arm group label: Human milk donors
intervention type: Other
intervention name: Human milk donors
description: Human milk donors for the Rogers Hixon Ontario Human Milk Bank
arm group label: Human milk donors
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
responsible party type: Sponsor-Investigator
investigator affiliation: The Hospital for Sick Children
investigator full name: Deborah O'Connor
investigator title: Scientist