xml: <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/NCT06025864</url>
    </required_header>
    <id_info>
      <org_study_id>5947.21</org_study_id>
      <nct_id>NCT06025864</nct_id>
    </id_info>
    <brief_title>Protocol to Support Breastfeeding for Postpartum Women and Mothers of Babies With Congenital Heart Disease</brief_title>
    <official_title>Support Protocol for Face-to-face and Teleservice Breastfeeding for Puerperal Women and Mothers of Babies With Congenital Heart Disease: a Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Instituto de Cardiologia do Rio Grande do Sul</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Irmandade Santa Casa de Misericórdia de Porto Alegre</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Instituto de Cardiologia do Rio Grande do Sul</source>
    <oversight_info>
      <has_dmc>Yes</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>
        To evaluate the effect of applying a hybrid protocol (face-to-face and via call center) of&#xD;
        breastfeeding assistance and guidance on the duration of breast milk supply to babies with&#xD;
        congenital heart disease for 6 months.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The objective of this randomized, multicenter clinical trial is to evaluate the effect of&#xD;
        applying a hybrid protocol (face-to-face and telemarketing) of assistance and guidance on&#xD;
        breastfeeding and duration of breast milk supply for infants with congenital heart disease in&#xD;
        the first 6 months of life. Recruitment of infants diagnosed with congenital heart disease&#xD;
        occurs within the first 72 hours of life, being followed up for 6 months.&#xD;
  &#xD;
        Initially, the mothers in the control group, as well as the mothers in the intervention&#xD;
        group, receive a booklet with guidelines on breastfeeding, a standardized measuring cup for&#xD;
        milk collections and a breastfeeding booklet.&#xD;
  &#xD;
        In addition, mothers in the intervention group receive monthly videos with guidance on&#xD;
        breastfeeding, monthly consultations with a breastfeeding consultant and a support group via&#xD;
        whatsapp with the researcher and scientific initiation student until the baby is 6 months&#xD;
        old.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2022</start_date>
    <completion_date type="Anticipated">February 20, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 20, 2023</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>
      <intervention_model_description>Multicenter Randomized Clinical Trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Breast milk supply rate during the baby's 6-month period</measure>
      <time_frame>Up to 6 months</time_frame>
      <description>Increase milk supply directly from the mother's breast or through pumps for use in alternative routes.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Compare the time of breastfeeding</measure>
      <time_frame>Up to 6 months</time_frame>
      <description>Compare the time of offering the breast between the control group and the intervention group</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Breastfeeding self-efficacy before and during the intervention</measure>
      <time_frame>Up to 6 months</time_frame>
      <description>The breastfeeding self-efficacy questionnaire in a reduced format (BSES-SF) will be applied in two moments during the infant's 6 months of life, and the effectiveness of the interventions can be observed. The score can vary from 1 to 70, where higher results reflect greater self-efficacy in breastfeeding.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assessment of the nutritional status of infants at 6 months of age using the growth curves of the World Health Organization and classified according to the Z score</measure>
      <time_frame>Up to 6 months</time_frame>
      <description>Assess the nutritional status of infants at 6 months of age through weight and height. These data will be placed on the nutritional assessment curves of the World Health Organization (WHO) and classified using the Z score. Afterwards, the results between the intervention and control groups will be compared.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">72</enrollment>
    <condition>Breastfeeding</condition>
    <condition>Congenital Heart Disease</condition>
    <arm_group>
      <arm_group_label>Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Support for breastfeeding and depletion of breast milk throughout the 6 months. Free and professional support through monthly consultations and videos on the subject.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>All mothers were followed up for 6 months and received a breastfeeding support booklet virtually, through a cell phone application. The booklet provides basic information about breastfeeding and possible complications. The recruited mothers also received a notebook to record the date, duration, volume and frequency of breastfeeding and/or milk collections, and the use of alternative routes such as a bottle, cup or enteral nutrition. At the initial visit, all mothers were given a standard measuring cup to measure the volume of milk used up in the household each day.&#xD;
  In addition, all mothers received a call 7 days after delivery to apply the Portuguese version of the Breastfeeding Self-Efficacy Survey - Short Form: BSES-SF. This questionnaire was reapplied after 90 days.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Breastfeeding</intervention_name>
      <description>Over the 6 months of the intervention, 1 video per month was sent, a total of 6 videos, via the mobile application, with guidance on breastfeeding: the importance of maternal hydration; myths and truths about the mother's diet; practical guidance on breastfeeding; baby's gastric capacity; picking up and positioning the baby during breastfeeding and storing milk for the return to work. There were also 1 call per month, with an average duration of 15 minutes, with a breastfeeding consultant nutritionist, aiming to solve doubts and difficulties that month. In order to provide complete assistance, virtual groups were created via the WhatsApp application, with a nutritionist and a health academic to solve doubts, provide emotional support and exchange information when necessary.&#xD;
  According to the region or municipality of origin of the mother-baby dyad, when necessary, this study provided the loan of a breast pump during the follow-up period or 6 months.</description>
      <arm_group_label>Intervention Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Infants diagnosed with congenital heart disease,&#xD;
  &#xD;
            -  The parents must have a cell phone enabled to receive video calls.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Mothers carriers of the human immunodeficiency virus (HIV),&#xD;
  &#xD;
            -  Mothers users of medications without medical indication to initiate or maintain&#xD;
               breastfeeding.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Day</minimum_age>
      <maximum_age>3 Days</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Fernanda Lucchese-Lobato, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Instituto de Cardiologia de Porto Alegre</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Juliana Caprini, Esp</last_name>
      <phone>(54)992044907</phone>
      <email>juli_caprini@yahoo.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Juliana Caprini</name>
        <address>
          <city>Caxias do Sul</city>
          <state>Rio Grande Do Sul</state>
          <zip>95080560</zip>
          <country>Brazil</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Juliana Caprini, Esp</last_name>
        <phone>(54)992044907</phone>
        <email>juli_caprini@yahoo.com</email>
      </contact>
      <investigator>
        <last_name>Fernanda Lucchese-Lobato, PHD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Juliana Caprini, Esp</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Brazil</country>
    </location_countries>
    <results_reference>
      <citation>Carlsen EM, Kyhnaeb A, Renault KM, Cortes D, Michaelsen KF, Pryds O. Telephone-based support prolongs breastfeeding duration in obese women: a randomized trial. Am J Clin Nutr. 2013 Nov;98(5):1226-32. doi: 10.3945/ajcn.113.059600. Epub 2013 Sep 4.</citation>
      <PMID>24004897</PMID>
    </results_reference>
    <results_reference>
      <citation>Dodt RC, Joventino ES, Aquino PS, Almeida PC, Ximenes LB. An experimental study of an educational intervention to promote maternal self-efficacy in breastfeeding. Rev Lat Am Enfermagem. 2015 Jul-Aug;23(4):725-32. doi: 10.1590/0104-1169.0295.2609.</citation>
      <PMID>26444176</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Instituto de Cardiologia do Rio Grande do Sul</investigator_affiliation>
      <investigator_full_name>Fernanda Lucchese</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>breast milk</keyword>
    <keyword>congenital heart desease</keyword>
    <keyword>nutritional status</keyword>
    <keyword>6 months</keyword>
    <keyword>call center</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Diseases</mesh_term>
      <mesh_term>Heart Defects, Congenital</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06025864
  org study id: 5947.21
  nct id: NCT06025864
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  To evaluate the effect of applying a hybrid protocol (face-to-face and via call center) of
        breastfeeding assistance and guidance on the duration of breast milk supply to babies with
        congenital heart disease for 6 months.
  The objective of this randomized, multicenter clinical trial is to evaluate the effect of
        applying a hybrid protocol (face-to-face and telemarketing) of assistance and guidance on
        breastfeeding and duration of breast milk supply for infants with congenital heart disease in
        the first 6 months of life. Recruitment of infants diagnosed with congenital heart disease
        occurs within the first 72 hours of life, being followed up for 6 months.
  
        Initially, the mothers in the control group, as well as the mothers in the intervention
        group, receive a booklet with guidelines on breastfeeding, a standardized measuring cup for
        milk collections and a breastfeeding booklet.
  
        In addition, mothers in the intervention group receive monthly videos with guidance on
        breastfeeding, monthly consultations with a breastfeeding consultant and a support group via
        whatsapp with the researcher and scientific initiation student until the baby is 6 months
        old.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Multicenter Randomized Clinical Trial
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Breast milk supply rate during the baby's 6-month period
  time frame: Up to 6 months
  description: Increase milk supply directly from the mother's breast or through pumps for use in alternative routes.
  measure: Compare the time of breastfeeding
  time frame: Up to 6 months
  description: Compare the time of offering the breast between the control group and the intervention group
  measure: Breastfeeding self-efficacy before and during the intervention
  time frame: Up to 6 months
  description: The breastfeeding self-efficacy questionnaire in a reduced format (BSES-SF) will be applied in two moments during the infant's 6 months of life, and the effectiveness of the interventions can be observed. The score can vary from 1 to 70, where higher results reflect greater self-efficacy in breastfeeding.
  measure: Assessment of the nutritional status of infants at 6 months of age using the growth curves of the World Health Organization and classified according to the Z score
  time frame: Up to 6 months
  description: Assess the nutritional status of infants at 6 months of age through weight and height. These data will be placed on the nutritional assessment curves of the World Health Organization (WHO) and classified using the Z score. Afterwards, the results between the intervention and control groups will be compared.
  arm group label: Intervention Group
  arm group type: Experimental
  description: Support for breastfeeding and depletion of breast milk throughout the 6 months. Free and professional support through monthly consultations and videos on the subject.
  arm group label: Control Group
  arm group type: No Intervention
  description: All mothers were followed up for 6 months and received a breastfeeding support booklet virtually, through a cell phone application. The booklet provides basic information about breastfeeding and possible complications. The recruited mothers also received a notebook to record the date, duration, volume and frequency of breastfeeding and/or milk collections, and the use of alternative routes such as a bottle, cup or enteral nutrition. At the initial visit, all mothers were given a standard measuring cup to measure the volume of milk used up in the household each day.
  In addition, all mothers received a call 7 days after delivery to apply the Portuguese version of the Breastfeeding Self-Efficacy Survey - Short Form: BSES-SF. This questionnaire was reapplied after 90 days.
  intervention type: Other
  intervention name: Breastfeeding
  description: Over the 6 months of the intervention, 1 video per month was sent, a total of 6 videos, via the mobile application, with guidance on breastfeeding: the importance of maternal hydration; myths and truths about the mother's diet; practical guidance on breastfeeding; baby's gastric capacity; picking up and positioning the baby during breastfeeding and storing milk for the return to work. There were also 1 call per month, with an average duration of 15 minutes, with a breastfeeding consultant nutritionist, aiming to solve doubts and difficulties that month. In order to provide complete assistance, virtual groups were created via the WhatsApp application, with a nutritionist and a health academic to solve doubts, provide emotional support and exchange information when necessary.
  According to the region or municipality of origin of the mother-baby dyad, when necessary, this study provided the loan of a breast pump during the follow-up period or 6 months.
  arm group label: Intervention Group
  criteria: 
  gender: All
  minimum age: 1 Day
  maximum age: 3 Days
  healthy volunteers: No
  last name: Fernanda Lucchese-Lobato, PHD
  role: Principal Investigator
  affiliation: Instituto de Cardiologia de Porto Alegre
  last name: Juliana Caprini, Esp
  phone: (54)992044907
  email: juli_caprini@yahoo.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  country: Brazil
  citation: Carlsen EM, Kyhnaeb A, Renault KM, Cortes D, Michaelsen KF, Pryds O. Telephone-based support prolongs breastfeeding duration in obese women: a randomized trial. Am J Clin Nutr. 2013 Nov;98(5):1226-32. doi: 10.3945/ajcn.113.059600. Epub 2013 Sep 4.
  PMID: 24004897
  citation: Dodt RC, Joventino ES, Aquino PS, Almeida PC, Ximenes LB. An experimental study of an educational intervention to promote maternal self-efficacy in breastfeeding. Rev Lat Am Enfermagem. 2015 Jul-Aug;23(4):725-32. doi: 10.1590/0104-1169.0295.2609.
  PMID: 26444176
  responsible party type: Principal Investigator
  investigator affiliation: Instituto de Cardiologia do Rio Grande do Sul
  investigator full name: Fernanda Lucchese
  investigator title: Principal Investigator
  mesh term: Heart Diseases
  mesh term: Heart Defects, Congenital
  sharing ipd: No