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/NCT06028581</url>
    </required_header>
    <id_info>
      <org_study_id>AICU-GULCAN002</org_study_id>
      <nct_id>NCT06028581</nct_id>
    </id_info>
    <brief_title>The Effect of Breastfeeding Support System</brief_title>
    <official_title>The Effect of Breastfeeding Support System in Newborns on Developmental Findings and Discharge Time</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Agri Ibrahim Cecen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Agri Ibrahim Cecen University</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>
        It is aimed to determine the effect of breastfeeding support system applied in newborns on&#xD;
        developmental findings and discharge time.The research was planned as an experimental study&#xD;
        with experimental and control groups. The population of the study consisted of babies who&#xD;
        received care and treatment in Iğdır State Hospital Neonatal Intensive Care Clinic between&#xD;
        February and June 2023. The sample of the study was calculated using the G*Power computer&#xD;
        program. In the calculation made, it was found that a total of 70 children, 35 of each for&#xD;
        the control and experimental groups, should be included. In this study, the experimental&#xD;
        group consisted of 36 children and the control group consisted of 35 children. Children&#xD;
        selected by simple random sampling method were divided into groups by randomization and which&#xD;
        group would be the experimental group and which group would be the control group were&#xD;
        determined by randomization. Masking was done during data collection and data analysis. The&#xD;
        data is in the analysis stage.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Breast milk is a natural food with high bioavailability, easy to digest, which reduces the&#xD;
        morbidity and mortality of the newborn, contains all the fluid, energy and nutrients&#xD;
        necessary for physical, spiritual and mental development.Breastfeeding has a biological and&#xD;
        emotional impact on mother and baby, has many immunological, psychological, social and&#xD;
        economic benefits for both mother and baby, and is the best method for maternal health and&#xD;
        healthy growth and development of infants.The bond between mother and baby after birth In the&#xD;
        sensitive period in which successful breastfeeding will be established by establishing a new&#xD;
        hospital, some babies need to be hospitalized in the neonatal intensive care unit (NICU) for&#xD;
        various reasons. During hospitalization, mothers cannot be with their babies during all&#xD;
        feedings and often have to empty their breasts with a pump. The pump does not have the same&#xD;
        physiological effect as breastfeeding on the milk injection response.&#xD;
  &#xD;
        Due to some problems arising from the breast or the baby, the baby may have problems in&#xD;
        grasping and holding the breast. In such cases, a breastfeeding support system can be used.&#xD;
  &#xD;
        The breastfeeding support system is based on the logic of stimulating the formation of&#xD;
        prolactin by the baby's sucking of the milk, assuming that it comes from the breast, with the&#xD;
        help of a plastic tube (usually a nasogastric tube) that is fixed to the breast on one end&#xD;
        and the other end inside the bottle/container containing breast milk or formula.With this&#xD;
        method, it is aimed to increase milk production and restart breastfeeding through active&#xD;
        sucking of the newborn and stimulation of the breasts.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 1, 2023</start_date>
    <completion_date type="Actual">July 30, 2023</completion_date>
    <primary_completion_date type="Actual">June 30, 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>Crossover Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>LATCH Breastfeeding Diagnostic Measurement Tool</measure>
      <time_frame>After each breastfeeding an average of 4 days</time_frame>
      <description>LATCH Breastfeeding Diagnostic Measurement The tool was developed by Jensen and Wallace in 1993 in Oregon. LATCH is a diagnostic tool created by analogy with the APGAR scoring system in terms of scoring method. Each item is evaluated between 0-2 points. The lowest 0 points and the highest 10 points are obtained from the scale. The Cronbach alpha coefficient of the LATCH Breastfeeding Diagnostic Measurement Tool was reported as 0.94 by Demirhan, 0.96 by Koyun, and 0.95 by Yenal and Okumuş.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">71</enrollment>
    <condition>Breastfeeding</condition>
    <arm_group>
      <arm_group_label>Experimental Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Breastfeeding support system will be applied to newborn babies in addition to breast milk.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Newborn babies will receive breast milk.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>breastfeeding support system</intervention_name>
      <description>Using the breastfeeding support system</description>
      <arm_group_label>Experimental Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          1. Inclusion Criteria: Before age of 28 days&#xD;
  &#xD;
            2. Exclusion Criteria: After age of 29 days&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Day</minimum_age>
      <maximum_age>28 Days</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Fatma GUL CAN, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Agri Ibrahim Cecen University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Eda GÜLBETEKİN, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Igdir University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Selahattin KARAGÖZ KARAGÖZ, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Iğdır State Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Agri Ibrahim Cecen University</name>
        <address>
          <city>Ağrı</city>
          <zip>04100</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Agri Ibrahim Cecen University</investigator_affiliation>
      <investigator_full_name>Fatma GUL CAN</investigator_full_name>
      <investigator_title>Investigator</investigator_title>
    </responsible_party>
    <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/NCT06028581
  org study id: AICU-GULCAN002
  nct id: NCT06028581
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  It is aimed to determine the effect of breastfeeding support system applied in newborns on
        developmental findings and discharge time.The research was planned as an experimental study
        with experimental and control groups. The population of the study consisted of babies who
        received care and treatment in Iğdır State Hospital Neonatal Intensive Care Clinic between
        February and June 2023. The sample of the study was calculated using the G*Power computer
        program. In the calculation made, it was found that a total of 70 children, 35 of each for
        the control and experimental groups, should be included. In this study, the experimental
        group consisted of 36 children and the control group consisted of 35 children. Children
        selected by simple random sampling method were divided into groups by randomization and which
        group would be the experimental group and which group would be the control group were
        determined by randomization. Masking was done during data collection and data analysis. The
        data is in the analysis stage.
  Breast milk is a natural food with high bioavailability, easy to digest, which reduces the
        morbidity and mortality of the newborn, contains all the fluid, energy and nutrients
        necessary for physical, spiritual and mental development.Breastfeeding has a biological and
        emotional impact on mother and baby, has many immunological, psychological, social and
        economic benefits for both mother and baby, and is the best method for maternal health and
        healthy growth and development of infants.The bond between mother and baby after birth In the
        sensitive period in which successful breastfeeding will be established by establishing a new
        hospital, some babies need to be hospitalized in the neonatal intensive care unit (NICU) for
        various reasons. During hospitalization, mothers cannot be with their babies during all
        feedings and often have to empty their breasts with a pump. The pump does not have the same
        physiological effect as breastfeeding on the milk injection response.
  
        Due to some problems arising from the breast or the baby, the baby may have problems in
        grasping and holding the breast. In such cases, a breastfeeding support system can be used.
  
        The breastfeeding support system is based on the logic of stimulating the formation of
        prolactin by the baby's sucking of the milk, assuming that it comes from the breast, with the
        help of a plastic tube (usually a nasogastric tube) that is fixed to the breast on one end
        and the other end inside the bottle/container containing breast milk or formula.With this
        method, it is aimed to increase milk production and restart breastfeeding through active
        sucking of the newborn and stimulation of the breasts.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Supportive Care
  masking: Single (Participant)
  measure: LATCH Breastfeeding Diagnostic Measurement Tool
  time frame: After each breastfeeding an average of 4 days
  description: LATCH Breastfeeding Diagnostic Measurement The tool was developed by Jensen and Wallace in 1993 in Oregon. LATCH is a diagnostic tool created by analogy with the APGAR scoring system in terms of scoring method. Each item is evaluated between 0-2 points. The lowest 0 points and the highest 10 points are obtained from the scale. The Cronbach alpha coefficient of the LATCH Breastfeeding Diagnostic Measurement Tool was reported as 0.94 by Demirhan, 0.96 by Koyun, and 0.95 by Yenal and Okumuş.
  arm group label: Experimental Group
  arm group type: Experimental
  description: Breastfeeding support system will be applied to newborn babies in addition to breast milk.
  arm group label: Control Group
  arm group type: No Intervention
  description: Newborn babies will receive breast milk.
  intervention type: Other
  intervention name: breastfeeding support system
  description: Using the breastfeeding support system
  arm group label: Experimental Group
  criteria: 
  gender: All
  minimum age: 1 Day
  maximum age: 28 Days
  healthy volunteers: Accepts Healthy Volunteers
  last name: Fatma GUL CAN, PhD
  role: Principal Investigator
  affiliation: Agri Ibrahim Cecen University
  last name: Eda GÜLBETEKİN, PhD
  role: Principal Investigator
  affiliation: Igdir University
  last name: Selahattin KARAGÖZ KARAGÖZ, PhD
  role: Principal Investigator
  affiliation: Iğdır State Hospital
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Agri Ibrahim Cecen University
  investigator full name: Fatma GUL CAN
  investigator title: Investigator
  sharing ipd: No