<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/NCT04492579</url>
  </required_header>
  <id_info>
    <org_study_id>5642622173</org_study_id>
    <nct_id>NCT04492579</nct_id>
  </id_info>
  <brief_title>Newborns Supplemented With Gentle-UHT Donor Milk</brief_title>
  <official_title>Neonates Supplemented With Gentle-UHT Donor Human Milk in the First Week of Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LactaLogics, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Renown Regional Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>LactaLogics, Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the effects of providing breastfeeding mothers with Gentle-UHT donor&#xD;
      human milk (GHM) after discharge to bridge the gap during delayed onset lactation, to support&#xD;
      an exclusive human milk diet and continued breastfeeding through the infant's first week of&#xD;
      life. The investigators aim to determine the safety of GHM, and if GHM provided to&#xD;
      breastfeeding mothers of outpatient babies with early weight loss will ensure babies&#xD;
      adequately gain weight according to age-matched controls.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 3, 2018</start_date>
  <completion_date type="Actual">January 17, 2020</completion_date>
  <primary_completion_date type="Actual">January 31, 2019</primary_completion_date>
  <phase>N/A</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight gain</measure>
    <time_frame>8-9 days of life</time_frame>
    <description>Average weights compared to WHO data</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Exclusive human milk diet</measure>
    <time_frame>8-9 days of life</time_frame>
    <description>Rates of infants still on an exclusive human milk diet</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Newborns</condition>
  <condition>Breast Milk Expression</condition>
  <arm_group>
    <arm_group_label>Supplementation of Gentle-UHT donor milk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Supplementation of Gentle-UHT donor milk in addition to mother's own milk, as recommended by the health care providers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Gentle-UHT donor human milk supplementation</intervention_name>
    <description>Providers referred mothers with newborns that fit the following criteria: exhibited insufficient milk supply, an infant with early weight loss born &gt;36 weeks gestation. Mother was given Gentle-UHT donor milk for supplementation, in addition to mother's own milk for the first week of the infant's life after hospital discharge.</description>
    <arm_group_label>Supplementation of Gentle-UHT donor milk</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gestational age &gt;36 weeks&#xD;
&#xD;
          -  Exclusively fed human milk&#xD;
&#xD;
          -  Age &lt;96 hours (4 days)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous admittance to the neonatal intensive care unit&#xD;
&#xD;
          -  Supplementation of any formula&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>4 Days</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rebecca Perry, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Renown Regional Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>LactaLogics, Inc.</name>
      <address>
        <city>Port Saint Lucie</city>
        <state>Florida</state>
        <zip>34952</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04492579
org study id: 5642622173
nct id: NCT04492579
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the effects of providing breastfeeding mothers with Gentle-UHT donor
      human milk (GHM) after discharge to bridge the gap during delayed onset lactation, to support
      an exclusive human milk diet and continued breastfeeding through the infant's first week of
      life. The investigators aim to determine the safety of GHM, and if GHM provided to
      breastfeeding mothers of outpatient babies with early weight loss will ensure babies
      adequately gain weight according to age-matched controls.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Weight gain
time frame: 8-9 days of life
description: Average weights compared to WHO data
measure: Exclusive human milk diet
time frame: 8-9 days of life
description: Rates of infants still on an exclusive human milk diet
arm group label: Supplementation of Gentle-UHT donor milk
arm group type: Experimental
description: Supplementation of Gentle-UHT donor milk in addition to mother's own milk, as recommended by the health care providers.
intervention type: Other
intervention name: Gentle-UHT donor human milk supplementation
description: Providers referred mothers with newborns that fit the following criteria: exhibited insufficient milk supply, an infant with early weight loss born >36 weeks gestation. Mother was given Gentle-UHT donor milk for supplementation, in addition to mother's own milk for the first week of the infant's life after hospital discharge.
arm group label: Supplementation of Gentle-UHT donor milk
criteria: 
gender: All
minimum age: N/A
maximum age: 4 Days
healthy volunteers: Accepts Healthy Volunteers
last name: Rebecca Perry, MD
role: Principal Investigator
affiliation: Renown Regional Medical Center
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No