<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/NCT03799367</url>
  </required_header>
  <id_info>
    <org_study_id>18/LO/0551</org_study_id>
    <nct_id>NCT03799367</nct_id>
  </id_info>
  <brief_title>The Feasibility of Drug Delivery to Infants During Breastfeeding</brief_title>
  <acronym>FEDD</acronym>
  <official_title>The Feasibility of Drug Delivery to Infants During Breastfeeding (FEDD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cambridge University Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Cambridge</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cambridge University Hospitals NHS Foundation Trust</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Parents commonly find giving medicines to babies, using oral syringes or spoons, difficult&#xD;
      and emotionally stressful. In developing countries, additional stress arises due to hygiene&#xD;
      difficulties and the lack of clean water. To overcome these challenges and encourage&#xD;
      breastfeeding, we have developed the concept of a Therapeutic Nipple Shield, a delivery&#xD;
      system that makes it possible to give medicine and nutrients to babies during breastfeeding.&#xD;
      It consists of a silicone nipple shield that allows the release of medicine/nutrients into&#xD;
      human milk during the feed. Presentations of a prototype to parents and staff at the Rosie&#xD;
      Hospital was very positive, and encouraged this clinical study. This study aims to give a&#xD;
      vitamin B12 supplement to babies during breastfeeding. The supplement will be placed into a&#xD;
      nipple shield, both of which are commercially available, and the mother will breastfeed her&#xD;
      baby as usual. Before and after the feed, we will 1) collect a small blood sample from the&#xD;
      baby to see whether the vitamin levels in the infant have increased, 2) ask the mother to&#xD;
      participate in two short interviews about her expectations and experiences using the&#xD;
      Therapeutic Nipple Shield.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 9, 2018</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</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>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Detection of the change in vitamin B12 concentration in the infants' blood 6-8 hours following vitamin B12 delivery from a nipple shield device during breastfeeding</measure>
    <time_frame>Blood sampling base line and 6-8 hours post feed</time_frame>
    <description>Two infant blood samples will be taken - one base line and one post intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Qualitative assessment of impact on maternal expectation, experience and acceptability</measure>
    <time_frame>Interviews will be conducted prior to and post interventional feed and will last about 30-50 min.</time_frame>
    <description>Semi-structured interviews will be conducted before and after vitamin B12 delivery during breastfeeding</description>
  </secondary_outcome>
  <enrollment type="Actual">26</enrollment>
  <condition>Medication Systems</condition>
  <condition>Breast Feeding</condition>
  <condition>Milk, Human</condition>
  <condition>Infant, Newborn</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Drug delivery during breastfeeding</intervention_name>
    <description>This study aims to give a vitamin B12 supplement to babies during breastfeeding. 30 mother-infant pairs will be recruited. The supplement will be placed into a nipple shield, both of which are commercially available, and the mother will breastfeed her baby as usual. Before and after the feed, we will 1) collect a small blood sample from the baby to see whether the vitamin levels in the infant have increased, 2) ask the mother to participate in two short interviews about her expectations and experiences using the Therapeutic Nipple Shield.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        No known allergy or hypersensitivity against any ingredient used in the study Infant aged&#xD;
        up to 12 months Confident breastfeeder (exclusively or non-exclusively)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        The participant may not enter the study if ANY of the following apply:&#xD;
&#xD;
          -  Not confident at breastfeeding&#xD;
&#xD;
          -  Infant not feeding properly&#xD;
&#xD;
          -  Allergy or hypersensitivity against any ingredient of the commercially available&#xD;
             Methylcobalamin Vitamin B12 Tablets (Just Vitamins Ltd, UK) used in the study (infant&#xD;
             or mother)&#xD;
&#xD;
          -  Medical conditions that could negatively influence swallowing, and thus breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Days</minimum_age>
    <maximum_age>12 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>addenbrookes Hospital</name>
      <address>
        <city>Cambridge</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>July 8, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>January 8, 2019</last_update_submitted>
  <last_update_submitted_qc>January 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cambridge University Hospitals NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>Kathryn Beardsall</investigator_full_name>
    <investigator_title>University Lecturer, University of Cambridge</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03799367
org study id: 18/LO/0551
nct id: NCT03799367
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Parents commonly find giving medicines to babies, using oral syringes or spoons, difficult
      and emotionally stressful. In developing countries, additional stress arises due to hygiene
      difficulties and the lack of clean water. To overcome these challenges and encourage
      breastfeeding, we have developed the concept of a Therapeutic Nipple Shield, a delivery
      system that makes it possible to give medicine and nutrients to babies during breastfeeding.
      It consists of a silicone nipple shield that allows the release of medicine/nutrients into
      human milk during the feed. Presentations of a prototype to parents and staff at the Rosie
      Hospital was very positive, and encouraged this clinical study. This study aims to give a
      vitamin B12 supplement to babies during breastfeeding. The supplement will be placed into a
      nipple shield, both of which are commercially available, and the mother will breastfeed her
      baby as usual. Before and after the feed, we will 1) collect a small blood sample from the
      baby to see whether the vitamin levels in the infant have increased, 2) ask the mother to
      participate in two short interviews about her expectations and experiences using the
      Therapeutic Nipple Shield.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Detection of the change in vitamin B12 concentration in the infants' blood 6-8 hours following vitamin B12 delivery from a nipple shield device during breastfeeding
time frame: Blood sampling base line and 6-8 hours post feed
description: Two infant blood samples will be taken - one base line and one post intervention
measure: Qualitative assessment of impact on maternal expectation, experience and acceptability
time frame: Interviews will be conducted prior to and post interventional feed and will last about 30-50 min.
description: Semi-structured interviews will be conducted before and after vitamin B12 delivery during breastfeeding
intervention type: Device
intervention name: Drug delivery during breastfeeding
description: This study aims to give a vitamin B12 supplement to babies during breastfeeding. 30 mother-infant pairs will be recruited. The supplement will be placed into a nipple shield, both of which are commercially available, and the mother will breastfeed her baby as usual. Before and after the feed, we will 1) collect a small blood sample from the baby to see whether the vitamin levels in the infant have increased, 2) ask the mother to participate in two short interviews about her expectations and experiences using the Therapeutic Nipple Shield.
criteria: 
gender: All
minimum age: 7 Days
maximum age: 12 Months
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Cambridge University Hospitals NHS Foundation Trust
investigator full name: Kathryn Beardsall
investigator title: University Lecturer, University of Cambridge
sharing ipd: Undecided