<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/NCT02994823</url>
  </required_header>
  <id_info>
    <org_study_id>POOL-BM</org_study_id>
    <nct_id>NCT02994823</nct_id>
  </id_info>
  <brief_title>The &quot;Pooling&quot; Expressed Breast Milk: A Method for Improving the Nutritional Intake of Premature Infants</brief_title>
  <acronym>POOL-BM</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Brest</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators compared a pooled mother's expressed breastmilk for 24 hours with&#xD;
      individual pump session collection of milk to provide a more consistent caloric product&#xD;
      without increasing bacterial contamination.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    prolonged device failure after just 10 participants and too long to resume&#xD;
  </why_stopped>
  <start_date type="Actual">June 2015</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>caloric value of breastmilk</measure>
    <time_frame>at the end of each 24 hours collection from inclusion to the end of collection during 4 days</time_frame>
    <description>The caloric value will be compared between the two groups (pooled expressed breastmilk versus individual expressed breastmilk)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>bacterial contamination of breastmilk</measure>
    <time_frame>at the end of each 24 hours collection from inclusion to the end of collection during 4 days</time_frame>
    <description>The bacterial contamination of breastmilk will be compared between the two groups with the value for colony-forming units per milliliter (cfu/mL) after plating on sheep blood agar and Chapman's agar.</description>
  </secondary_outcome>
  <enrollment type="Actual">10</enrollment>
  <condition>Breastfeeding Mothers of Infants Hospitalized</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Breastfeeding mothers of infants hospitalized&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mother of newborn hospitalized in intensive care unit&#xD;
&#xD;
          -  Mother using a breast pump in the unit and / or at home&#xD;
&#xD;
          -  Mother respected the rules of handling and transport breastmilk&#xD;
&#xD;
          -  No opposition mother&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refusal&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Murielle Dobrzynski</last_name>
    <role>Study Director</role>
    <affiliation>CHRU de Brest</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHUR de Brest</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>September 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>January 14, 2020</last_update_submitted>
  <last_update_submitted_qc>January 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT02994823
org study id: POOL-BM
nct id: NCT02994823
lead sponsor: 
has dmc: No
The investigators compared a pooled mother's expressed breastmilk for 24 hours with
      individual pump session collection of milk to provide a more consistent caloric product
      without increasing bacterial contamination.
observational model: Case-Crossover
time perspective: Prospective
measure: caloric value of breastmilk
time frame: at the end of each 24 hours collection from inclusion to the end of collection during 4 days
description: The caloric value will be compared between the two groups (pooled expressed breastmilk versus individual expressed breastmilk)
measure: bacterial contamination of breastmilk
time frame: at the end of each 24 hours collection from inclusion to the end of collection during 4 days
description: The bacterial contamination of breastmilk will be compared between the two groups with the value for colony-forming units per milliliter (cfu/mL) after plating on sheep blood agar and Chapman's agar.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Murielle Dobrzynski
role: Study Director
affiliation: CHRU de Brest
facility: 
country: France
responsible party type: Sponsor