<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/NCT02221167</url>
  </required_header>
  <id_info>
    <org_study_id>201406730</org_study_id>
    <nct_id>NCT02221167</nct_id>
  </id_info>
  <brief_title>Rx Milk Study of Donor Milk Supplementation to Improve Breastfeeding Outcomes</brief_title>
  <acronym>Rx Milk</acronym>
  <official_title>Rx Milk: Donor Milk Supplementation to Increase Breastfeeding Duration &amp; Exclusivity, a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laura Kair</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Children's Miracle Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Gerber Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Iowa</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a randomized controlled trial seeking to determine whether supplementing&#xD;
      infants at risk for excessive neonatal weight loss with a small volume of human donor milk&#xD;
      prophylactically in the first 1-3 days of life, before maternal mature milk production&#xD;
      (before mom's milk &quot;comes in&quot;) will decrease the incidence of formula use at 1 week and 1, 2,&#xD;
      and 3 months of life and increase the rate of exclusive breastfeeding in this high-risk&#xD;
      population.&#xD;
&#xD;
      We hypothesize that supplementation of term infants who have lost greater than or equal to 5%&#xD;
      birth weight by 36 hours of age with a small volume of donor breast milk following feeds,&#xD;
      until mature milk production, will result in decreased supplemental formula use at 1 week and&#xD;
      increased exclusive as well as any breastfeeding at 1 week and 1, 2, and 3 months. This&#xD;
      study's specific aims are to compare the effectiveness of encouraging in-hospital exclusive&#xD;
      breastfeeding with offering early small-volume donor milk supplementation in a population of&#xD;
      infants at risk for excessive neonatal weight loss with goals of 1) decreasing the incidence&#xD;
      of formula supplementation at 1 week of life and 2) improving breastfeeding duration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Any formula use at 1 week of age</measure>
    <time_frame>1 week</time_frame>
    <description>Any formula intake within the last 24 hours.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Exclusive breastfeeding</measure>
    <time_frame>3 months</time_frame>
    <description>Infants receiving breast milk and no formula in the last 24 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any breastfeeding at 3 months</measure>
    <time_frame>3 months</time_frame>
    <description>Infants receiving some breast milk in addition to some formula in the last 24 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any breastfeeding</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exclusive breastfeeding</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exclusive breastfeeding</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any breastfeeding</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any breastfeeding</measure>
    <time_frame>1 week</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Breastfeeding Duration</condition>
  <condition>Exclusive Breastfeeding</condition>
  <condition>Donor Milk Supplementation</condition>
  <arm_group>
    <arm_group_label>Exclusive breastfeeding</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Infants in the exclusive breastfeeding group will continue to breastfeed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Donor Milk</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Infants in this arm will continue to breastfeed and will be given 10 ml of donor breast milk by syringe after each breastfeeding until their mother's milk &quot;comes in.&quot; (until the onset of lactogenesis II)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Donor Milk</intervention_name>
    <description>breastfeeding plus 10 ml of donor milk by syringe after each breastfeeding until mother's milk &quot;comes in.&quot;</description>
    <arm_group_label>Donor Milk</arm_group_label>
    <other_name>donor breast milk</other_name>
    <other_name>human donor milk</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gestational age greater than or equal to 37 weeks&#xD;
&#xD;
          -  Weight loss greater than or equal to 5% (rounded to nearest whole percent) of birth&#xD;
             weight in the first 36 hours after birth&#xD;
&#xD;
          -  Chronologic age of 24-48 hours old at the time of study enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  twins and higher level multiples&#xD;
&#xD;
          -  infant has congenital or chromosomal anomalies that may affect feeding, diagnosed&#xD;
             prior to study enrollment&#xD;
&#xD;
          -  mother incarcerated&#xD;
&#xD;
          -  mother's age &lt;18 years&#xD;
&#xD;
          -  mother reports mature milk production prior to study enrollment&#xD;
&#xD;
          -  mother does not speak English&#xD;
&#xD;
          -  infants offered &gt; 1 supplemental feeding of formula or donor milk&#xD;
&#xD;
          -  weight loss greater than 10%&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>24 Hours</minimum_age>
    <maximum_age>48 Hours</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura R Kair, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Iowa</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tarah T Colaizy, MD, MPH</last_name>
    <role>Study Director</role>
    <affiliation>University of Iowa</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Valerie J Flaherman, MD, MPH</last_name>
    <role>Study Director</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Iowa Children's Hospital</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.babyfriendlyusa.org/about-us/baby-friendly-hospital-initiative/the-ten-steps</url>
    <description>Baby Friendly USA</description>
  </link>
  <link>
    <url>http://www.jointcommission.org/core_measure_sets.aspx</url>
    <description>Joint Commission Perinatal Core Measures</description>
  </link>
  <reference>
    <citation>Flaherman VJ, Aby J, Burgos AE, Lee KA, Cabana MD, Newman TB. Effect of early limited formula on duration and exclusivity of breastfeeding in at-risk infants: an RCT. Pediatrics. 2013 Jun;131(6):1059-65. doi: 10.1542/peds.2012-2809. Epub 2013 May 13.</citation>
    <PMID>23669513</PMID>
  </reference>
  <reference>
    <citation>Flaherman VJ, Kuzniewicz MW, Li S, Walsh E, McCulloch CE, Newman TB. First-day weight loss predicts eventual weight nadir for breastfeeding newborns. Arch Dis Child Fetal Neonatal Ed. 2013 Nov;98(6):F488-92. doi: 10.1136/archdischild-2012-303076. Epub 2013 Jul 17.</citation>
    <PMID>23864443</PMID>
  </reference>
  <reference>
    <citation>Flaherman VJ, Bokser S, Newman TB. First-day newborn weight loss predicts in-hospital weight nadir for breastfeeding infants. Breastfeed Med. 2010 Aug;5(4):165-8. doi: 10.1089/bfm.2009.0047.</citation>
    <PMID>20113202</PMID>
  </reference>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>March 14, 2018</last_update_submitted>
  <last_update_submitted_qc>March 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Iowa</investigator_affiliation>
    <investigator_full_name>Laura Kair</investigator_full_name>
    <investigator_title>Adjunct Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>breastfeeding</keyword>
  <keyword>donor milk</keyword>
  <keyword>formula</keyword>
  <keyword>exclusive breastfeeding</keyword>
  <keyword>newborn</keyword>
  <!-- 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/NCT02221167
org study id: 201406730
nct id: NCT02221167
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This study is a randomized controlled trial seeking to determine whether supplementing
      infants at risk for excessive neonatal weight loss with a small volume of human donor milk
      prophylactically in the first 1-3 days of life, before maternal mature milk production
      (before mom's milk "comes in") will decrease the incidence of formula use at 1 week and 1, 2,
      and 3 months of life and increase the rate of exclusive breastfeeding in this high-risk
      population.

      We hypothesize that supplementation of term infants who have lost greater than or equal to 5%
      birth weight by 36 hours of age with a small volume of donor breast milk following feeds,
      until mature milk production, will result in decreased supplemental formula use at 1 week and
      increased exclusive as well as any breastfeeding at 1 week and 1, 2, and 3 months. This
      study's specific aims are to compare the effectiveness of encouraging in-hospital exclusive
      breastfeeding with offering early small-volume donor milk supplementation in a population of
      infants at risk for excessive neonatal weight loss with goals of 1) decreasing the incidence
      of formula supplementation at 1 week of life and 2) improving breastfeeding duration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Any formula use at 1 week of age
time frame: 1 week
description: Any formula intake within the last 24 hours.
measure: Exclusive breastfeeding
time frame: 3 months
description: Infants receiving breast milk and no formula in the last 24 hours.
measure: Any breastfeeding at 3 months
time frame: 3 months
description: Infants receiving some breast milk in addition to some formula in the last 24 hours.
measure: Any breastfeeding
time frame: 1 month
measure: Exclusive breastfeeding
time frame: 1 month
measure: Exclusive breastfeeding
time frame: 2 months
measure: Any breastfeeding
time frame: 2 months
measure: Any breastfeeding
time frame: 1 week
arm group label: Exclusive breastfeeding
arm group type: No Intervention
description: Infants in the exclusive breastfeeding group will continue to breastfeed.
arm group label: Donor Milk
arm group type: Active Comparator
description: Infants in this arm will continue to breastfeed and will be given 10 ml of donor breast milk by syringe after each breastfeeding until their mother's milk "comes in." (until the onset of lactogenesis II)
intervention type: Other
intervention name: Donor Milk
description: breastfeeding plus 10 ml of donor milk by syringe after each breastfeeding until mother's milk "comes in."
arm group label: Donor Milk
other name: donor breast milk
other name: human donor milk
criteria: 
gender: All
minimum age: 24 Hours
maximum age: 48 Hours
healthy volunteers: No
last name: Laura R Kair, MD
role: Principal Investigator
affiliation: University of Iowa
last name: Tarah T Colaizy, MD, MPH
role: Study Director
affiliation: University of Iowa
last name: Valerie J Flaherman, MD, MPH
role: Study Director
affiliation: University of California, San Francisco
facility: 
country: United States
url: http://www.babyfriendlyusa.org/about-us/baby-friendly-hospital-initiative/the-ten-steps
description: Baby Friendly USA
url: http://www.jointcommission.org/core_measure_sets.aspx
description: Joint Commission Perinatal Core Measures
citation: Flaherman VJ, Aby J, Burgos AE, Lee KA, Cabana MD, Newman TB. Effect of early limited formula on duration and exclusivity of breastfeeding in at-risk infants: an RCT. Pediatrics. 2013 Jun;131(6):1059-65. doi: 10.1542/peds.2012-2809. Epub 2013 May 13.
PMID: 23669513
citation: Flaherman VJ, Kuzniewicz MW, Li S, Walsh E, McCulloch CE, Newman TB. First-day weight loss predicts eventual weight nadir for breastfeeding newborns. Arch Dis Child Fetal Neonatal Ed. 2013 Nov;98(6):F488-92. doi: 10.1136/archdischild-2012-303076. Epub 2013 Jul 17.
PMID: 23864443
citation: Flaherman VJ, Bokser S, Newman TB. First-day newborn weight loss predicts in-hospital weight nadir for breastfeeding infants. Breastfeed Med. 2010 Aug;5(4):165-8. doi: 10.1089/bfm.2009.0047.
PMID: 20113202
responsible party type: Sponsor-Investigator
investigator affiliation: University of Iowa
investigator full name: Laura Kair
investigator title: Adjunct Assistant Professor