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/NCT06003959</url>
    </required_header>
    <id_info>
      <org_study_id>Sumeyye</org_study_id>
      <nct_id>NCT06003959</nct_id>
    </id_info>
    <brief_title>The Effect of Breastfeeding Support System</brief_title>
    <official_title>The Effect of Breastfeeding Support System on Breast Milk Quantity and Mother-Infant Bonding in Preterm Infants: A Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ataturk University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ataturk 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>
        This study was conducted to investigate the effect of a breastfeeding support system on&#xD;
        breast milk quantity and mother-infant attachment in preterm infants. This randomized&#xD;
        controlled experimental study was conducted in the Level III Neonatal Intensive Care Unit&#xD;
        (NICU) of a hospital in eastern Turkey between January and June 2022. The population of the&#xD;
        study consisted of preterm infants and their mothers who received treatment and care in the&#xD;
        NICU between the dates of the study. The study sample consisted of 70 preterm infants (35&#xD;
        experimental, 35 control) and their mothers who met the research criteria.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2022</start_date>
    <completion_date type="Actual">June 30, 2023</completion_date>
    <primary_completion_date type="Actual">June 30, 2022</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>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Mother-Infant Attachment Scale</measure>
      <time_frame>up to 6 months</time_frame>
      <description>The Turkish validity and reliability of this scale developed by Taylor et al. in 2005 was conducted by Aydemir Karakulak and Alparslan (2016). It is a scale that allows the mother to express her feelings towards her baby with a single word. This scale, which can be applied from the first day after birth, can be easily and quickly applied by the mother. The scale has 8 items and four Likert-type items. A score between 0 and 24 can be obtained from the scale. An increase in the score indicates that there is an attachment problem between the mother and the infant. Cronbach Alpha internal consistency coefficients of the scale were found to be 0.69 in the first stage and 0.68 in the second stage</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">70</enrollment>
    <condition>Preterm</condition>
    <condition>Breastfeeding</condition>
    <condition>Breast Milk</condition>
    <condition>Breastfeeding Support System</condition>
    <arm_group>
      <arm_group_label>Breastfeeding Support System</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The intervention group was given breastfeeding support system care</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Routine nursing care was given to the pretrms in this groups without any breastfeeding support system care</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Routine nursing care</intervention_name>
      <description>Preterm infants in the control group did not receive any intervention other than the routine feeding protocol applied in the clinic. Body weights of the babies were measured and recorded in the morning before the first feeding. The amount of breast milk to be given for feeding according to the clinic protocol was determined by the physician and the babies were fed with a bottle. The mothers of preterm infants were asked to fill out the Mother-Infant Attachment Scale before and after the feeding of their infants. These interventions were continued until the baby was fully breastfed.</description>
      <arm_group_label>Breastfeeding Support System</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>breastfeeding support system</intervention_name>
      <description>Body weight of preterm infants in the experimental group was measured and recorded in the morning before the first feeding. The mothers of preterm infants were asked to fill out the Mother-Infant Attachment Scale in the pre-procedure period. The amount of breast milk that the preterm infant should receive during feeding was determined by the physician. Before feeding, the neonatal nurse ensured sterile preparation of the milk and transferred it to the Breastfeeding Support System. The mothers were then prepared for the procedure. Accordingly, the breastfeeding support system was explained to the mother by the specialized neonatal nurse. When the preparation of the mother and baby was completed, the baby was placed on the mother's breast. After feeding, the mother was asked to fill out the Mother-Infant Attachment Scale the again. These interventions were continued until the baby was fully transferred to the mother's breast.</description>
      <arm_group_label>Breastfeeding Support System</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  For the baby&#xD;
  &#xD;
            -  Gestation week between 30 weeks and 34 weeks,&#xD;
  &#xD;
            -  Birth weight of 1000 g and above,&#xD;
  &#xD;
            -  Spontaneous respiration,&#xD;
  &#xD;
            -  His vital signs are stable,&#xD;
  &#xD;
            -  Born with a 5-minute APGAR of 7 and above,&#xD;
  &#xD;
            -  Gavage-fed exclusively with breast and/or formula milk and ready to be switched to&#xD;
               oral feeding,&#xD;
  &#xD;
            -  Grade III and IV intracranial hemorrhage and no periventricular locomosis,&#xD;
  &#xD;
            -  No known congenital diseases,&#xD;
  &#xD;
            -  Severe asphyxia, without chronic lung disease,&#xD;
  &#xD;
            -  Babies who did not develop NEC were included in the study. For mothers&#xD;
  &#xD;
            -  Over 18 years of age, literate, able to speak Turkish,&#xD;
  &#xD;
            -  Mothers who were willing to breastfeed and did not have a chronic disease that&#xD;
               prevented breastfeeding were included in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Unidentified babies,&#xD;
  &#xD;
            -  Infants with unstable vital signs,&#xD;
  &#xD;
            -  Mothers with an obstacle to breastfeeding were excluded.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Months</minimum_age>
      <maximum_age>34 Months</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Sümeyye EKİCİ</name>
        <address>
          <city>Erzurum</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ataturk University</investigator_affiliation>
      <investigator_full_name>Sümeyye EKİCİ</investigator_full_name>
      <investigator_title>Research Assistant</investigator_title>
    </responsible_party>
    <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>
    <!-- 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/NCT06003959
  org study id: Sumeyye
  nct id: NCT06003959
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study was conducted to investigate the effect of a breastfeeding support system on
        breast milk quantity and mother-infant attachment in preterm infants. This randomized
        controlled experimental study was conducted in the Level III Neonatal Intensive Care Unit
        (NICU) of a hospital in eastern Turkey between January and June 2022. The population of the
        study consisted of preterm infants and their mothers who received treatment and care in the
        NICU between the dates of the study. The study sample consisted of 70 preterm infants (35
        experimental, 35 control) and their mothers who met the research criteria.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Mother-Infant Attachment Scale
  time frame: up to 6 months
  description: The Turkish validity and reliability of this scale developed by Taylor et al. in 2005 was conducted by Aydemir Karakulak and Alparslan (2016). It is a scale that allows the mother to express her feelings towards her baby with a single word. This scale, which can be applied from the first day after birth, can be easily and quickly applied by the mother. The scale has 8 items and four Likert-type items. A score between 0 and 24 can be obtained from the scale. An increase in the score indicates that there is an attachment problem between the mother and the infant. Cronbach Alpha internal consistency coefficients of the scale were found to be 0.69 in the first stage and 0.68 in the second stage
  arm group label: Breastfeeding Support System
  arm group type: Experimental
  description: The intervention group was given breastfeeding support system care
  arm group label: Control group
  arm group type: No Intervention
  description: Routine nursing care was given to the pretrms in this groups without any breastfeeding support system care
  intervention type: Other
  intervention name: Routine nursing care
  description: Preterm infants in the control group did not receive any intervention other than the routine feeding protocol applied in the clinic. Body weights of the babies were measured and recorded in the morning before the first feeding. The amount of breast milk to be given for feeding according to the clinic protocol was determined by the physician and the babies were fed with a bottle. The mothers of preterm infants were asked to fill out the Mother-Infant Attachment Scale before and after the feeding of their infants. These interventions were continued until the baby was fully breastfed.
  arm group label: Breastfeeding Support System
  intervention type: Other
  intervention name: breastfeeding support system
  description: Body weight of preterm infants in the experimental group was measured and recorded in the morning before the first feeding. The mothers of preterm infants were asked to fill out the Mother-Infant Attachment Scale in the pre-procedure period. The amount of breast milk that the preterm infant should receive during feeding was determined by the physician. Before feeding, the neonatal nurse ensured sterile preparation of the milk and transferred it to the Breastfeeding Support System. The mothers were then prepared for the procedure. Accordingly, the breastfeeding support system was explained to the mother by the specialized neonatal nurse. When the preparation of the mother and baby was completed, the baby was placed on the mother's breast. After feeding, the mother was asked to fill out the Mother-Infant Attachment Scale the again. These interventions were continued until the baby was fully transferred to the mother's breast.
  arm group label: Breastfeeding Support System
  criteria: 
  gender: All
  minimum age: 30 Months
  maximum age: 34 Months
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Ataturk University
  investigator full name: Sümeyye EKİCİ
  investigator title: Research Assistant
  mesh term: Premature Birth
  sharing ipd: No