<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/NCT03280381</url>
  </required_header>
  <id_info>
    <org_study_id>978912-3</org_study_id>
    <nct_id>NCT03280381</nct_id>
  </id_info>
  <brief_title>Nifty Feeding Cup Versus Generic Medicine Cup Preterm Infants Who Have Difficulty Breastfeeding</brief_title>
  <official_title>Randomized Crossover Trial of the Nifty Feeding Cup and a Medicine Cup in Preterm Infants Who Have Difficulty Breastfeeding</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PATH</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Seattle Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Komfo Anokye Teaching Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>PATH</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>
      The investigators will establish an evidence base for the Nifty Feeding Cup by evaluating its&#xD;
      effectiveness and caregiver satisfaction. The investigators will conduct a randomized&#xD;
      crossover trial that compares the Nifty Feeding Cup to a standardized, generic medicine cup&#xD;
      used to feed preterm infants with breastfeeding difficulties at Komfo Anokye Teaching&#xD;
      Hospital (KATH) in Kumasi, Ghana.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators aim to compare the Nifty Feeding Cup to a standardized, generic cup in up&#xD;
      to 200 preterm infants. The aim and hypotheses were selected based on the most informative&#xD;
      outcomes given the scope of the funding. The investigators will test the hypotheses that&#xD;
      Nifty Feeding Cup feeding compared to generic cup feeding will result in:&#xD;
&#xD;
        1. Less spillage&#xD;
&#xD;
        2. Greater caregiver satisfaction&#xD;
&#xD;
        3. Shorter duration of feeds&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 15, 2017</start_date>
  <completion_date type="Actual">September 25, 2018</completion_date>
  <primary_completion_date type="Actual">September 25, 2018</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Investigators will conduct a randomized crossover trial in mothers/caregivers with a preterm infant in the mother-baby unit at Komfo Anokye Teaching Hospital (KATH) in Kumasi, Ghana. Each caregiver/infant pair will use the Nifty Feeding Cup for two feeds and the standardized generic cup for two feeds. Cross-over means each caregiver/infant pair will use both cups, with the order of the cup used first and second randomized.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Caregiver Satisfaction [Immediate]</measure>
    <time_frame>24-36 hours</time_frame>
    <description>Caregiver's satisfaction will be the cup she prefers, which will be recorded in the In-Hospital Preference Survey completed after the caregiver has finished the feeding portion of the study. Data refers to number of caregivers who prefer the Nifty Cup.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Spillage</measure>
    <time_frame>24-36 hours</time_frame>
    <description>Spillage will be reported as a percent with the amount of milk in grams spilled/mopped up divided by the total amount of milk weighed in grams less the total amount of milk not used. Each caregiver-infant pair will be provided with a bib cloth for each observed feeding. The bib cloth will be weighed before and after each feed and the weights recorded on the Feeding Assessment form. The difference between the pre and post weights will be used as the measure of the amount spilled. A digital scale will be used to measure the milk weight, which will be recorded in grams.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Infant,Premature</condition>
  <condition>Feeding; Difficult, Newborn</condition>
  <arm_group>
    <arm_group_label>NIFTY Feeding Cup First</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each caregiver/infant pair will first use the Nifty Feeding Cup for two feeds and then the standardized generic cup for two feeds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Generic Medicine Cup First</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each caregiver/infant pair will first use the standardized generic cup for two feeds and then the Nifty Feeding Cup for two feeds.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nifty feeding cup</intervention_name>
    <description>The 40 mL Nifty Feeding Cup features an extended reservoir off the lip of the cup that holds a small bolus of milk, ensuring efficient delivery of milk, is made of a durable, soft, silicone material that protects the infant's mouth from injury, has embossed measurements help with tracking volume and intake of milk, is ergonomically designed for frequent use and to enhance finger and wrist control of milk flow and is made from a quick-drying, ultraviolet radiation-resistant, durable, affordable silicone that can be boiled for sterilization. Mothers can directly express into the cup, reducing possible cross-contamination from other containers.</description>
    <arm_group_label>Generic Medicine Cup First</arm_group_label>
    <arm_group_label>NIFTY Feeding Cup First</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Generic medicine cup</intervention_name>
    <description>The generic cup that will be used in this study is a small medicine cup 30 ml in size.Small medicine cups are manufactured by a variety of manufacturers and are commonly used in health facilities to feed breastmilk to infants who are having breastfeeding difficulties. The cups are generally translucent, calibrated with a variety of measurements including 2.5-30 mL.</description>
    <arm_group_label>Generic Medicine Cup First</arm_group_label>
    <arm_group_label>NIFTY Feeding Cup First</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Infant&#xD;
&#xD;
          -  Born preterm (&lt;37 weeks gestational age) at time of birth&#xD;
&#xD;
          -  Corrected gestational age is &lt;37 weeks per the modified Dubowitz score on date of&#xD;
             enrollment&#xD;
&#xD;
          -  Diagnosed with feeding difficulties&#xD;
&#xD;
          -  Patient in the mother-baby unit at KATH&#xD;
&#xD;
          -  Clinically indicated to start cup feeding (including an infant who has a nasogastric&#xD;
             tube and is cup feeding or indicated to start cup feeding)&#xD;
&#xD;
          -  Has an anticipated hospital stay that is at least 48 hours&#xD;
&#xD;
        Caregiver:&#xD;
&#xD;
          -  At least 18 years of age&#xD;
&#xD;
          -  One of the following biologic family members of the infant (Mother, Grandmother, Aunt)&#xD;
&#xD;
          -  Self-identifies as the primary feeder of the infant&#xD;
&#xD;
          -  Prior experience feeding the potential infant participant with nipple feeding (e.g.&#xD;
             breast feeding, bottle feeding) or nasogastric [NG] tube&#xD;
&#xD;
          -  Verifies willingness to comply with all study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Infant&#xD;
&#xD;
          -  Congenital anomaly except for minor anomalies (e.g. an extra digit or ear tag is okay)&#xD;
&#xD;
          -  Other condition or situation that makes infant unlikely to be able to comply with&#xD;
             study procedures. Examples include the infant anticipated to not be in hospital long&#xD;
             enough, infant has a suspected intestinal obstruction, or necrotizing enterocolitis.&#xD;
&#xD;
          -  No mother, grandmother, or aunt caregiver available to participate in study&#xD;
&#xD;
          -  Enrolled in another study at KATH that would interfere with his/her ability to&#xD;
             participate in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christy McKinney, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seattle Children's</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Komfo Anokye Teaching Hospital (KATH)</name>
      <address>
        <city>Kumasi</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ghana</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <results_first_submitted>June 12, 2019</results_first_submitted>
  <results_first_submitted_qc>August 7, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">August 8, 2019</results_first_posted>
  <last_update_submitted>August 7, 2019</last_update_submitted>
  <last_update_submitted_qc>August 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nifty Cup</keyword>
  <keyword>breastfeeding difficulties</keyword>
  <keyword>preterm infant</keyword>
  <keyword>cup feeding</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 24, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT03280381/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>NIFTY Feeding Cup First</title>
          <description>Each caregiver/infant pair will first use the Nifty Feeding Cup for two feeds and then the standardized generic cup for two feeds.&#xD;
Nifty Feeding Cup: The 40 mL cup features an extended reservoir off the lip of the cup that holds a small bolus of milk, has embossed measurements to track volume and intake of milk, is ergonomically designed for frequent use and to enhance finger and wrist control of milk flow and is made from a quick-drying, ultraviolet radiation-resistant, durable, affordable and soft silicone that can be boiled for sterilization. Mothers can directly express into the cup, reducing possible cross-contamination from other containers.&#xD;
Generic medicine cup: A generic 30 mL small medicine cup was used in this study. Small medicine cups are manufactured by many manufacturers and are generally translucent and calibrated with a variety of measurements. They are commonly used in health facilities to feed breastmilk to infants who are having breastfeeding difficulties.</description>
        </group>
        <group group_id="P2">
          <title>Generic Medicine Cup First</title>
          <description>Each caregiver/infant pair will first use the standardized generic cup for two feeds and then the Nifty Feeding Cup for two feeds.&#xD;
Nifty Feeding Cup: The 40 mL cup features an extended reservoir off the lip of the cup that holds a small bolus of milk, has embossed measurements to track volume and intake of milk, is ergonomically designed for frequent use and to enhance finger and wrist control of milk flow and is made from a quick-drying, ultraviolet radiation-resistant, durable, affordable and soft silicone that can be boiled for sterilization. Mothers can directly express into the cup, reducing possible cross-contamination from other containers.&#xD;
Generic medicine cup: A generic 30 mL small medicine cup was used in this study. Small medicine cups are manufactured by many manufacturers and are generally translucent and calibrated with a variety of measurements. They are commonly used in health facilities to feed breastmilk to infants who are having breastfeeding difficulties.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="101"/>
                <participants group_id="P2" count="99"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="101"/>
                <participants group_id="P2" count="97"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>NIFTY Feeding Cup First</title>
          <description>Each caregiver/infant pair will first use the Nifty Feeding Cup for two feeds and then the standardized generic cup for two feeds.&#xD;
Nifty Feeding Cup: The 40 mL cup features an extended reservoir off the lip of the cup that holds a small bolus of milk, has embossed measurements to track volume and intake of milk, is ergonomically designed for frequent use and to enhance finger and wrist control of milk flow and is made from a quick-drying, ultraviolet radiation-resistant, durable, affordable and soft silicone that can be boiled for sterilization. Mothers can directly express into the cup, reducing possible cross-contamination from other containers.&#xD;
Generic medicine cup: A generic 30 mL small medicine cup was used in this study. Small medicine cups are manufactured by many manufacturers and are generally translucent and calibrated with a variety of measurements. They are commonly used in health facilities to feed breastmilk to infants who are having breastfeeding difficulties.</description>
        </group>
        <group group_id="B2">
          <title>Generic Medicine Cup First</title>
          <description>Each caregiver/infant pair will first use the Nifty Feeding Cup for two feeds and then the standardized generic cup for two feeds.&#xD;
Nifty Feeding Cup: The 40 mL cup features an extended reservoir off the lip of the cup that holds a small bolus of milk, has embossed measurements to track volume and intake of milk, is ergonomically designed for frequent use and to enhance finger and wrist control of milk flow and is made from a quick-drying, ultraviolet radiation-resistant, durable, affordable and soft silicone that can be boiled for sterilization. Mothers can directly express into the cup, reducing possible cross-contamination from other containers.&#xD;
Generic medicine cup: A generic 30 mL small medicine cup was used in this study. Small medicine cups are manufactured by many manufacturers and are generally translucent and calibrated with a variety of measurements. They are commonly used in health facilities to feed breastmilk to infants who are having breastfeeding difficulties.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="101"/>
            <count group_id="B2" value="99"/>
            <count group_id="B3" value="200"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="101"/>
                    <count group_id="B2" value="99"/>
                    <count group_id="B3" value="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="101"/>
                    <measurement group_id="B2" value="99"/>
                    <measurement group_id="B3" value="200"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>Baseline demographic data</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="101"/>
                    <count group_id="B2" value="99"/>
                    <count group_id="B3" value="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="101"/>
                    <measurement group_id="B2" value="99"/>
                    <measurement group_id="B3" value="200"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Caregiver Satisfaction [Immediate]</title>
        <description>Caregiver's satisfaction will be the cup she prefers, which will be recorded in the In-Hospital Preference Survey completed after the caregiver has finished the feeding portion of the study. Data refers to number of caregivers who prefer the Nifty Cup.</description>
        <time_frame>24-36 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NIFTY Feeding Cup First</title>
            <description>Each caregiver/infant pair will first use the Nifty Feeding Cup for two feeds and then the standardized generic cup for two feeds.&#xD;
Nifty Feeding Cup: The 40 mL cup features an extended reservoir off the lip of the cup that holds a small bolus of milk, has embossed measurements to track volume and intake of milk, is ergonomically designed for frequent use and to enhance finger and wrist control of milk flow and is made from a quick-drying, ultraviolet radiation-resistant, durable, affordable and soft silicone that can be boiled for sterilization. Mothers can directly express into the cup, reducing possible cross-contamination from other containers.&#xD;
Generic medicine cup: A generic 30 mL small medicine cup was used in this study. Small medicine cups are manufactured by many manufacturers and are generally translucent and calibrated with a variety of measurements. They are commonly used in health facilities to feed breastmilk to infants who are having breastfeeding difficulties.</description>
          </group>
          <group group_id="O2">
            <title>Generic Medicine Cup First</title>
            <description>Each caregiver/infant pair will first use the standardized generic cup for two feeds and then the Nifty Feeding Cup for two feeds.&#xD;
Nifty Feeding Cup: The 40 mL cup features an extended reservoir off the lip of the cup that holds a small bolus of milk, has embossed measurements to track volume and intake of milk, is ergonomically designed for frequent use and to enhance finger and wrist control of milk flow and is made from a quick-drying, ultraviolet radiation-resistant, durable, affordable and soft silicone that can be boiled for sterilization. Mothers can directly express into the cup, reducing possible cross-contamination from other containers.&#xD;
Generic medicine cup: A generic 30 mL small medicine cup was used in this study. Small medicine cups are manufactured by many manufacturers and are generally translucent and calibrated with a variety of measurements. They are commonly used in health facilities to feed breastmilk to infants who are having breastfeeding difficulties.</description>
          </group>
        </group_list>
        <measure>
          <title>Caregiver Satisfaction [Immediate]</title>
          <description>Caregiver's satisfaction will be the cup she prefers, which will be recorded in the In-Hospital Preference Survey completed after the caregiver has finished the feeding portion of the study. Data refers to number of caregivers who prefer the Nifty Cup.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82"/>
                    <measurement group_id="O2" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Spillage</title>
        <description>Spillage will be reported as a percent with the amount of milk in grams spilled/mopped up divided by the total amount of milk weighed in grams less the total amount of milk not used. Each caregiver-infant pair will be provided with a bib cloth for each observed feeding. The bib cloth will be weighed before and after each feed and the weights recorded on the Feeding Assessment form. The difference between the pre and post weights will be used as the measure of the amount spilled. A digital scale will be used to measure the milk weight, which will be recorded in grams.</description>
        <time_frame>24-36 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NIFTY Feeding Cup First</title>
            <description>Each caregiver/infant pair will first use the Nifty Feeding Cup for two feeds and then the standardized generic cup for two feeds.&#xD;
Nifty Feeding Cup: The 40 mL cup features an extended reservoir off the lip of the cup that holds a small bolus of milk, has embossed measurements to track volume and intake of milk, is ergonomically designed for frequent use and to enhance finger and wrist control of milk flow and is made from a quick-drying, ultraviolet radiation-resistant, durable, affordable and soft silicone that can be boiled for sterilization. Mothers can directly express into the cup, reducing possible cross-contamination from other containers.&#xD;
Generic medicine cup: A generic 30 mL small medicine cup was used in this study. Small medicine cups are manufactured by many manufacturers and are generally translucent and calibrated with a variety of measurements. They are commonly used in health facilities to feed breastmilk to infants who are having breastfeeding difficulties.</description>
          </group>
          <group group_id="O2">
            <title>Generic Medicine Cup First</title>
            <description>Each caregiver/infant pair will first use the Nifty Feeding Cup for two feeds and then the standardized generic cup for two feeds.&#xD;
Nifty Feeding Cup: The 40 mL cup features an extended reservoir off the lip of the cup that holds a small bolus of milk, has embossed measurements to track volume and intake of milk, is ergonomically designed for frequent use and to enhance finger and wrist control of milk flow and is made from a quick-drying, ultraviolet radiation-resistant, durable, affordable and soft silicone that can be boiled for sterilization. Mothers can directly express into the cup, reducing possible cross-contamination from other containers.&#xD;
Generic medicine cup: A generic 30 mL small medicine cup was used in this study. Small medicine cups are manufactured by many manufacturers and are generally translucent and calibrated with a variety of measurements. They are commonly used in health facilities to feed breastmilk to infants who are having breastfeeding difficulties.</description>
          </group>
        </group_list>
        <measure>
          <title>Spillage</title>
          <description>Spillage will be reported as a percent with the amount of milk in grams spilled/mopped up divided by the total amount of milk weighed in grams less the total amount of milk not used. Each caregiver-infant pair will be provided with a bib cloth for each observed feeding. The bib cloth will be weighed before and after each feed and the weights recorded on the Feeding Assessment form. The difference between the pre and post weights will be used as the measure of the amount spilled. A digital scale will be used to measure the milk weight, which will be recorded in grams.</description>
          <units>percentage of feed spilled</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.9" spread="6.9"/>
                    <measurement group_id="O2" value="9.3" spread="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Data were collected over the time it took mothers to feed their infants twice with each cup, an average of 13 minutes per feed.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>NIFTY Feeding Cup First</title>
          <description>Each caregiver/infant pair will first use the Nifty Feeding Cup for two feeds and then the standardized generic cup for two feeds.&#xD;
Nifty Feeding Cup: The 40 mL cup features an extended reservoir off the lip of the cup that holds a small bolus of milk, has embossed measurements to track volume and intake of milk, is ergonomically designed for frequent use and to enhance finger and wrist control of milk flow and is made from a quick-drying, ultraviolet radiation-resistant, durable, affordable and soft silicone that can be boiled for sterilization. Mothers can directly express into the cup, reducing possible cross-contamination from other containers.&#xD;
Generic medicine cup: A generic 30 mL small medicine cup was used in this study. Small medicine cups are manufactured by many manufacturers and are generally translucent and calibrated with a variety of measurements. They are commonly used in health facilities to feed breastmilk to infants who are having breastfeeding difficulties.</description>
        </group>
        <group group_id="E2">
          <title>Generic Medicine Cup First</title>
          <description>Each caregiver/infant pair will first use the standardized generic cup for two feeds and then the Nifty Feeding Cup for two feeds.&#xD;
Nifty Feeding Cup: The 40 mL cup features an extended reservoir off the lip of the cup that holds a small bolus of milk, has embossed measurements to track volume and intake of milk, is ergonomically designed for frequent use and to enhance finger and wrist control of milk flow and is made from a quick-drying, ultraviolet radiation-resistant, durable, affordable and soft silicone that can be boiled for sterilization. Mothers can directly express into the cup, reducing possible cross-contamination from other containers.&#xD;
Generic medicine cup: A generic 30 mL small medicine cup was used in this study. Small medicine cups are manufactured by many manufacturers and are generally translucent and calibrated with a variety of measurements. They are commonly used in health facilities to feed breastmilk to infants who are having breastfeeding difficulties.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Patricia S. Coffey</name_or_title>
      <organization>PATH</organization>
      <phone>206-302-4704</phone>
      <email>pcoffey@path.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03280381
org study id: 978912-3
nct id: NCT03280381
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators will establish an evidence base for the Nifty Feeding Cup by evaluating its
      effectiveness and caregiver satisfaction. The investigators will conduct a randomized
      crossover trial that compares the Nifty Feeding Cup to a standardized, generic medicine cup
      used to feed preterm infants with breastfeeding difficulties at Komfo Anokye Teaching
      Hospital (KATH) in Kumasi, Ghana.
The investigators aim to compare the Nifty Feeding Cup to a standardized, generic cup in up
      to 200 preterm infants. The aim and hypotheses were selected based on the most informative
      outcomes given the scope of the funding. The investigators will test the hypotheses that
      Nifty Feeding Cup feeding compared to generic cup feeding will result in:

        1. Less spillage

        2. Greater caregiver satisfaction

        3. Shorter duration of feeds
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Investigators will conduct a randomized crossover trial in mothers/caregivers with a preterm infant in the mother-baby unit at Komfo Anokye Teaching Hospital (KATH) in Kumasi, Ghana. Each caregiver/infant pair will use the Nifty Feeding Cup for two feeds and the standardized generic cup for two feeds. Cross-over means each caregiver/infant pair will use both cups, with the order of the cup used first and second randomized.
primary purpose: Other
masking: Single (Investigator)
measure: Caregiver Satisfaction [Immediate]
time frame: 24-36 hours
description: Caregiver's satisfaction will be the cup she prefers, which will be recorded in the In-Hospital Preference Survey completed after the caregiver has finished the feeding portion of the study. Data refers to number of caregivers who prefer the Nifty Cup.
measure: Spillage
time frame: 24-36 hours
description: Spillage will be reported as a percent with the amount of milk in grams spilled/mopped up divided by the total amount of milk weighed in grams less the total amount of milk not used. Each caregiver-infant pair will be provided with a bib cloth for each observed feeding. The bib cloth will be weighed before and after each feed and the weights recorded on the Feeding Assessment form. The difference between the pre and post weights will be used as the measure of the amount spilled. A digital scale will be used to measure the milk weight, which will be recorded in grams.
arm group label: NIFTY Feeding Cup First
arm group type: Experimental
description: Each caregiver/infant pair will first use the Nifty Feeding Cup for two feeds and then the standardized generic cup for two feeds.
arm group label: Generic Medicine Cup First
arm group type: Experimental
description: Each caregiver/infant pair will first use the standardized generic cup for two feeds and then the Nifty Feeding Cup for two feeds.
intervention type: Other
intervention name: Nifty feeding cup
description: The 40 mL Nifty Feeding Cup features an extended reservoir off the lip of the cup that holds a small bolus of milk, ensuring efficient delivery of milk, is made of a durable, soft, silicone material that protects the infant's mouth from injury, has embossed measurements help with tracking volume and intake of milk, is ergonomically designed for frequent use and to enhance finger and wrist control of milk flow and is made from a quick-drying, ultraviolet radiation-resistant, durable, affordable silicone that can be boiled for sterilization. Mothers can directly express into the cup, reducing possible cross-contamination from other containers.
arm group label: Generic Medicine Cup First
arm group label: NIFTY Feeding Cup First
intervention type: Other
intervention name: Generic medicine cup
description: The generic cup that will be used in this study is a small medicine cup 30 ml in size.Small medicine cups are manufactured by a variety of manufacturers and are commonly used in health facilities to feed breastmilk to infants who are having breastfeeding difficulties. The cups are generally translucent, calibrated with a variety of measurements including 2.5-30 mL.
arm group label: Generic Medicine Cup First
arm group label: NIFTY Feeding Cup First
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christy McKinney, Ph.D.
role: Principal Investigator
affiliation: Seattle Children's
facility: 
country: Ghana
responsible party type: Sponsor
mesh term: Premature Birth
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 