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/NCT06035419</url>
    </required_header>
    <id_info>
      <org_study_id>PAU SBF</org_study_id>
      <nct_id>NCT06035419</nct_id>
    </id_info>
    <brief_title>The Effect of Breastfeeding Education to Immigrant Mothers in the NICU on Breastfeeding Success</brief_title>
    <official_title>The Effect of Training Given to Immigrant Primiparous Mothers in the Neonatal Intensive Care Unit on Breastfeeding Success</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Pamukkale University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Pamukkale 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>
        Feeding the infant with breast milk in neonatal intensive care units is essential. However,&#xD;
        breastfeeding can be adversely affected in this complex environment, especially for immigrant&#xD;
        mothers. In order to ensure the success of breastfeeding in the neonatal intensive care unit,&#xD;
        education and support of the mother are required. While doing this, structured and planned&#xD;
        education programs should be implemented taking into account the individual characteristics&#xD;
        of the mother (culture, age, etc.).This study aimed to evaluate the effect of education given&#xD;
        to immigrant mothers on breastfeeding success of mothers. The study was a randomized&#xD;
        controlled, single-blind clinical trial.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study aimed to evaluate the effect of education given to immigrant mothers on&#xD;
        breastfeeding success of mothers.&#xD;
  &#xD;
        Method: In this randomized-controlled, single-blind study, 80 immigrant mothers (40&#xD;
        intervention groups, 40 control groups) were recruited.&#xD;
  &#xD;
        The study included primiparous immigrant mothers whose mother tongue was not Turkish, whose&#xD;
        baby was hospitalized for the first time in the NICU, whose baby was born at 34-40 weeks of&#xD;
        gestation, whose baby was fed orally, and whose suckling was not impaired.&#xD;
  &#xD;
        In the study, 40 participants were included in the experimental group and 40 participants in&#xD;
        the control group. At the end of the study, Cohen's d was calculated to determine the effect&#xD;
        size and was found to be 1.80.&#xD;
  &#xD;
        A simple randomization method was used to randomly assign the mothers included in the study&#xD;
        to the experimental and control groups. To avoid bias in the study, a nurse who was not&#xD;
        involved in the study made the LATCH scoring and evaluation of the suckling time and feeding&#xD;
        style of the infants, without knowing which group the mothers were in. In addition, mothers&#xD;
        to be included in the experimental and control groups were determined by a simple&#xD;
        randomization method to prevent selection bias in the study.&#xD;
  &#xD;
        Mother-baby information form, Nutrition follow-up form, and LATCH were used to collect the&#xD;
        study data.&#xD;
  &#xD;
        The mothers to be included in the study were informed by an interpreter before the study and&#xD;
        their consent was obtained. It was ensured that the mothers in both groups answered the&#xD;
        questions in the data collection forms through a translator. Information about the baby was&#xD;
        taken from the patient's file.&#xD;
  &#xD;
        A specially prepared training program for immigrant mothers was applied to the mothers in the&#xD;
        experimental group. In the control group, no interventions were made except for the routine&#xD;
        interventions of the clinic (unstructured training practices given by the individual effort&#xD;
        of the nurse).&#xD;
  &#xD;
        The first of the parameters used to evaluate breastfeeding success is the mothers' LATCH&#xD;
        score averages. LATCH scores of mothers were evaluated by observation. LATCH evaluations of&#xD;
        the mothers in the experimental group were made at the first breastfeeding before the&#xD;
        training and on the 1st, 2nd, and 3rd days after the training. The LATCH evaluations of the&#xD;
        control group were made at the first breastfeeding and on the 1st, 2nd, and 3rd days.&#xD;
  &#xD;
        Another parameter examined to evaluate breastfeeding success is the suckling time of babies&#xD;
        at each breastfeeding. The suckling time of the babies was measured with a stopwatch at each&#xD;
        feeding.&#xD;
  &#xD;
        The last of the parameters to evaluate breastfeeding success is the feeding style of infants.&#xD;
        Information about the feeding style of infants was obtained from the nurse observation form.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 2, 2019</start_date>
    <completion_date type="Actual">February 15, 2020</completion_date>
    <primary_completion_date type="Actual">February 7, 2020</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>randomized-controlled and single-blind study</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>In order to avoid bias in the study, a nurse who was not involved in the study performed the LATCH scoring and evaluation of the suckling time and feeding style of the infants, without knowing which group the mothers were in. In addition, mothers to be included in the experimental and control groups were determined by simple randomization method in order to prevent selection bias in the study.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>LATCH score</measure>
      <time_frame>3 days</time_frame>
      <description>LATCH was used to evaluate breastfeeding success. Each item is evaluated between 0-2 points. The total score that can be obtained from the vehicle is 10, and a high score means high breastfeeding success. Evaluation is done through observation.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>sucking time of babies</measure>
      <time_frame>3 days</time_frame>
      <description>To evaluate the suckling time of babies, sucking time was measured with a stopwatch at each feeding.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>feeding type of babies</measure>
      <time_frame>3 days</time_frame>
      <description>Information about the feeding style of infants was obtained from the nurse observation form. The characteristics for the type of nutrition are; breastfeeding only, spoon feeding only, spoon feeding and breastfeeding together.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">80</enrollment>
    <condition>Breastfeeding</condition>
    <condition>Immigrant</condition>
    <arm_group>
      <arm_group_label>education</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A specially prepared training program for immigrant mothers was applied to the mothers in the experimental group.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No interventions were made to the control group other than the routine interventions of the clinic (unstructured training practices given by the individual effort of the nurse).</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>education</intervention_name>
      <description>breastfeeding education for migrant mothers</description>
      <arm_group_label>education</arm_group_label>
      <other_name>breastfeeding education</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Immigrant mothers whose baby was hospitalized for the first time in the NICU, whose&#xD;
               baby was born at 34-40 weeks of gestation, whose baby was fed orally and who did not&#xD;
               prevent suckling, whose mother tongue was not Turkish, and who volunteered to&#xD;
               participate in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Migrant mothers whose babies were hospitalized in the NICU before, whose baby was&#xD;
               younger than 34 weeks of gestation, whose baby was not fed orally, who were not&#xD;
               primiparous, and who did not volunteer to participate in the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Pamukkale University</name>
        <address>
          <city>Denizli</city>
          <state>Pamukkale</state>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 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 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Pamukkale University</investigator_affiliation>
      <investigator_full_name>Sibel Serap Ceylan</investigator_full_name>
      <investigator_title>Associate professor, PhD, RN</investigator_title>
    </responsible_party>
    <keyword>Breast milk</keyword>
    <keyword>Neonatal intensive care</keyword>
    <keyword>Immigrant</keyword>
    <keyword>Breastfeeding</keyword>
    <keyword>Education</keyword>
    <!-- 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/NCT06035419
  org study id: PAU SBF
  nct id: NCT06035419
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Feeding the infant with breast milk in neonatal intensive care units is essential. However,
        breastfeeding can be adversely affected in this complex environment, especially for immigrant
        mothers. In order to ensure the success of breastfeeding in the neonatal intensive care unit,
        education and support of the mother are required. While doing this, structured and planned
        education programs should be implemented taking into account the individual characteristics
        of the mother (culture, age, etc.).This study aimed to evaluate the effect of education given
        to immigrant mothers on breastfeeding success of mothers. The study was a randomized
        controlled, single-blind clinical trial.
  This study aimed to evaluate the effect of education given to immigrant mothers on
        breastfeeding success of mothers.
  
        Method: In this randomized-controlled, single-blind study, 80 immigrant mothers (40
        intervention groups, 40 control groups) were recruited.
  
        The study included primiparous immigrant mothers whose mother tongue was not Turkish, whose
        baby was hospitalized for the first time in the NICU, whose baby was born at 34-40 weeks of
        gestation, whose baby was fed orally, and whose suckling was not impaired.
  
        In the study, 40 participants were included in the experimental group and 40 participants in
        the control group. At the end of the study, Cohen's d was calculated to determine the effect
        size and was found to be 1.80.
  
        A simple randomization method was used to randomly assign the mothers included in the study
        to the experimental and control groups. To avoid bias in the study, a nurse who was not
        involved in the study made the LATCH scoring and evaluation of the suckling time and feeding
        style of the infants, without knowing which group the mothers were in. In addition, mothers
        to be included in the experimental and control groups were determined by a simple
        randomization method to prevent selection bias in the study.
  
        Mother-baby information form, Nutrition follow-up form, and LATCH were used to collect the
        study data.
  
        The mothers to be included in the study were informed by an interpreter before the study and
        their consent was obtained. It was ensured that the mothers in both groups answered the
        questions in the data collection forms through a translator. Information about the baby was
        taken from the patient's file.
  
        A specially prepared training program for immigrant mothers was applied to the mothers in the
        experimental group. In the control group, no interventions were made except for the routine
        interventions of the clinic (unstructured training practices given by the individual effort
        of the nurse).
  
        The first of the parameters used to evaluate breastfeeding success is the mothers' LATCH
        score averages. LATCH scores of mothers were evaluated by observation. LATCH evaluations of
        the mothers in the experimental group were made at the first breastfeeding before the
        training and on the 1st, 2nd, and 3rd days after the training. The LATCH evaluations of the
        control group were made at the first breastfeeding and on the 1st, 2nd, and 3rd days.
  
        Another parameter examined to evaluate breastfeeding success is the suckling time of babies
        at each breastfeeding. The suckling time of the babies was measured with a stopwatch at each
        feeding.
  
        The last of the parameters to evaluate breastfeeding success is the feeding style of infants.
        Information about the feeding style of infants was obtained from the nurse observation form.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: randomized-controlled and single-blind study
  primary purpose: Supportive Care
  masking: Single (Participant)
  masking description: In order to avoid bias in the study, a nurse who was not involved in the study performed the LATCH scoring and evaluation of the suckling time and feeding style of the infants, without knowing which group the mothers were in. In addition, mothers to be included in the experimental and control groups were determined by simple randomization method in order to prevent selection bias in the study.
  measure: LATCH score
  time frame: 3 days
  description: LATCH was used to evaluate breastfeeding success. Each item is evaluated between 0-2 points. The total score that can be obtained from the vehicle is 10, and a high score means high breastfeeding success. Evaluation is done through observation.
  measure: sucking time of babies
  time frame: 3 days
  description: To evaluate the suckling time of babies, sucking time was measured with a stopwatch at each feeding.
  measure: feeding type of babies
  time frame: 3 days
  description: Information about the feeding style of infants was obtained from the nurse observation form. The characteristics for the type of nutrition are; breastfeeding only, spoon feeding only, spoon feeding and breastfeeding together.
  arm group label: education
  arm group type: Experimental
  description: A specially prepared training program for immigrant mothers was applied to the mothers in the experimental group.
  arm group label: control
  arm group type: No Intervention
  description: No interventions were made to the control group other than the routine interventions of the clinic (unstructured training practices given by the individual effort of the nurse).
  intervention type: Other
  intervention name: education
  description: breastfeeding education for migrant mothers
  arm group label: education
  other name: breastfeeding education
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Pamukkale University
  investigator full name: Sibel Serap Ceylan
  investigator title: Associate professor, PhD, RN