<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/NCT01699841</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 1111002616</org_study_id>
    <nct_id>NCT01699841</nct_id>
  </id_info>
  <brief_title>Breast Milk Composition and HIV-exposed/Unexposed Early Infant Growth and Infectious Disease Events</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cornell University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to understand how breast milk may protect infants from infection&#xD;
      and promote favorable immunological, growth and development outcomes. By following mothers&#xD;
      and their infants, we will evaluate the important interactions between infant immune&#xD;
      responses and infectious disease events in relation to breast milk composition and feeding&#xD;
      patterns. Our aim is to identify a set of predictive factors corresponding to healthy early&#xD;
      infant growth and development in this setting in Northern Tanzania.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2012</start_date>
  <completion_date type="Actual">June 30, 2013</completion_date>
  <primary_completion_date type="Actual">June 15, 2013</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>Breast milk composition</measure>
    <time_frame>Up to 6 months post-partum</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Infant anthropometric measures</measure>
    <time_frame>Up to 6 months of age</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant infectious disease events</measure>
    <time_frame>Up to 6 months of age</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">208</enrollment>
  <condition>HIV</condition>
  <condition>Malnutrition</condition>
  <condition>Cryptosporidiosis</condition>
  <arm_group>
    <arm_group_label>HIV+ and HIV- mothers and their infants</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        HIV+ and HIV- mothers and their infants attending a semi-rural clinic and/or rural&#xD;
        dispensaries from birth to 6 months of infant age in north western Tanzania.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent provided by mothers, and parental consent on behalf of their infants&#xD;
&#xD;
          -  Confirmed maternal HIV status (HIV-1, HIV-2 or HIV-Dual seropositive or&#xD;
             HIV-seronegative)&#xD;
&#xD;
          -  Stated intention to remain in the clinic catchment area ≥6 months post-partum&#xD;
&#xD;
          -  Singleton birth&#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>Kisesa Health Centre</name>
      <address>
        <city>Kisesa</city>
        <country>Tanzania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Tanzania</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>October 30, 2017</last_update_submitted>
  <last_update_submitted_qc>October 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2017</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>Cryptosporidiosis</mesh_term>
    <mesh_term>Malnutrition</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/NCT01699841
org study id: IRB 1111002616
nct id: NCT01699841
lead sponsor: 
has dmc: No
The purpose of this study is to understand how breast milk may protect infants from infection
      and promote favorable immunological, growth and development outcomes. By following mothers
      and their infants, we will evaluate the important interactions between infant immune
      responses and infectious disease events in relation to breast milk composition and feeding
      patterns. Our aim is to identify a set of predictive factors corresponding to healthy early
      infant growth and development in this setting in Northern Tanzania.
observational model: Cohort
time perspective: Prospective
measure: Breast milk composition
time frame: Up to 6 months post-partum
measure: Infant anthropometric measures
time frame: Up to 6 months of age
measure: Infant infectious disease events
time frame: Up to 6 months of age
arm group label: HIV+ and HIV- mothers and their infants
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: Tanzania
responsible party type: Sponsor
mesh term: Cryptosporidiosis
mesh term: Malnutrition