<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/NCT03755999</url>
  </required_header>
  <id_info>
    <org_study_id>MOST 107-2314-B-006-009-MY3</org_study_id>
    <nct_id>NCT03755999</nct_id>
  </id_info>
  <brief_title>A Cue-based Developmental Approach Toward the Preterm Infants During Feeding Transition Period</brief_title>
  <official_title>A Cue-based Developmental Approach Toward the Preterm Infants During Feeding Transition Period - Explore Clinical Facts, Evaluate Intervention Effects and Develop Clinical Guideline</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cheng-Kung University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Science and Technology, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Cheng-Kung University Hospital</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>
      The coordination of sucking, swallowing, and breathing during the transition from gavage to&#xD;
      oral feeding is a challenge for preterm infants. Efficient management of the feeding&#xD;
      transition without other comorbidities can not only improve their oral movements and&#xD;
      gastrointestinal function development, facilitate their oral feeding learning behavior, but&#xD;
      also facilitate them to direct breastfeeding, improve mother-infant attachment, and&#xD;
      ultimately reduce the length of hospitalization. However, the current status of strategies in&#xD;
      supporting preterm infants throughout their feeding transition are inconsistent, and lack of&#xD;
      guidelines and monitor indicators based on existing evidence.&#xD;
&#xD;
      This project proposed a three-year plan the explore the current situation, examine effective&#xD;
      strategies for care bundles, and further develop a new clinical guideline that can be&#xD;
      implemented in the future. The first year of this research will use chart review among two&#xD;
      neonatal intensive care units of Medical Center from Taipei and Tainan. A semi-structured&#xD;
      interview and questionnaire (DSCS-N) will be used to explore nurses' knowledge, attitude and&#xD;
      skills of developmental care; and the experience of caring for preterm infants during feeding&#xD;
      transition in the neonatal intensive care units. In addition, gestational age, body weight,&#xD;
      gavage and oral feeding amount, and special events happened during feeding will be recorded&#xD;
      and analyzed.&#xD;
&#xD;
      The second year, an experimental with a stratified random assignment and repeated measure&#xD;
      design will be used with feeding transition care bundles. 120 preterm infants will be&#xD;
      recruited and assigned to experimental or control group. The subjects will be fed by the&#xD;
      routine care approach or by the feeding transition approach in one neonatal intensive care&#xD;
      unit. Intervention components include oral stimulation and cue-based feeding during the&#xD;
      transition to oral feeding. Study measures will include physical indicators, POFRAS and EFS&#xD;
      during feeding to evaluate the implementation and guide further development of the clinical&#xD;
      guideline.&#xD;
&#xD;
      The third year of guideline development will follow Bowker and the National Health Insurance&#xD;
      Bureau which including 5 stage. The results of this guideline can offer better&#xD;
      recommendations to support preterm infants' oral development, provide cue-based feeding, and&#xD;
      help them succeed in the transition to oral nutrition.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Anticipated">July 31, 2023</completion_date>
  <primary_completion_date type="Actual">July 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Preterm infant's oral feeding readiness</measure>
    <time_frame>Change from day 1(Baseline) up to day 7 in oral stimulation phase</time_frame>
    <description>We use the Preterm Oral Feeding Readiness Assessment Scales (POFRAS) to assess preterm infants' readiness to start oral feeding. The scale comprised of 5 five categories including corrected Gestational Age, Behavioral Organization (3 item), Oral Posture (2 item), Oral Reflexes (4 item), Nonnutritive Sucking (8 item) with a total of 18 items to evaluate. Each item score from 0~2, the higher the score means that the preterm infant has better oral feeding preparation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Preterm infant's oral feeding skills</measure>
    <time_frame>From day 1(Baseline) up to the day 30 in cue-base feeding phase</time_frame>
    <description>Using Early Feeding Skills Assessments for Preterm Infants (EFS). The Early Feeding Skills Assessments for Preterm Infants (EFS) checklist is to assess preterm infants' oral feeding readiness (before feeding; yes/no), oral feeding skill (when feeding; all/most/some/none; never/occasionally/often), oral feeding tolerance (after feeding; yes/no) and feeding descriptors(after feeding).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body weight change</measure>
    <time_frame>Change from day 1(baseline) up to the day 200.</time_frame>
    <description>body weight change in grams</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hospital stay length(days)</measure>
    <time_frame>From day 1 up to the day 200.</time_frame>
    <description>How many days from admission(birth day) to discharge(leave) hospital.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Preterm Infant</condition>
  <condition>Feeding Behavior</condition>
  <condition>Feeding Patterns</condition>
  <arm_group>
    <arm_group_label>PIOMI treat group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Preterm infant receive oral massage using the premature infant oral motor intervention (PIOMI)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine care group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Preterm infant receive routine care of neonatal intensive care unit(NICU)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>The premature infant oral motor intervention (PIOMI)</intervention_name>
    <description>The premature infant oral motor intervention (PIOMI) is an oral motor program that provides assisted movement to activate muscle contraction and provides movement against resistance to build strength in the areas of the mouth necessary for feeding. It is designed to increase the maturation of neural structures, improving their ability to suck and swallow.</description>
    <arm_group_label>PIOMI treat group</arm_group_label>
    <other_name>Cue-based feeding</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Preterm infant born less then 33 weeks&#xD;
&#xD;
          -  Fraction of inspired oxygen(FiO2) less then 30%&#xD;
&#xD;
          -  Can tolerance enteral feeding&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Using ventilator(except non-invasive ventilator)&#xD;
&#xD;
          -  Complications including Hypoxic Ischemic Encephalopathy (HIE), Intraventricular&#xD;
             Hemorrhage (IVH) ≥Grade III, Periventricular Leukomalacia (PVL), Necrotizing&#xD;
             Enterocolitis(NEC) ≥Stage II&#xD;
&#xD;
          -  Congenital abnormalities including chromosomal abnormalities, congenital anomalies of&#xD;
             digestive system, cleft lip and palate&#xD;
&#xD;
          -  Because of custody problem or can't get the inform consent of the preterm infant's&#xD;
             parents/guardian&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>33 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mei-Chih Huang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Nursing, College of Medicine, National Cheng-Kung University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <zip>70101</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
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  <verification_date>July 2022</verification_date>
  <study_first_submitted>August 22, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>September 29, 2022</last_update_submitted>
  <last_update_submitted_qc>September 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>preterm infants</keyword>
  <keyword>transitional feeding period</keyword>
  <keyword>cue-based care</keyword>
  <keyword>clinical guidelines</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
  </condition_browse>
  <!-- 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/NCT03755999
org study id: MOST 107-2314-B-006-009-MY3
nct id: NCT03755999
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The coordination of sucking, swallowing, and breathing during the transition from gavage to
      oral feeding is a challenge for preterm infants. Efficient management of the feeding
      transition without other comorbidities can not only improve their oral movements and
      gastrointestinal function development, facilitate their oral feeding learning behavior, but
      also facilitate them to direct breastfeeding, improve mother-infant attachment, and
      ultimately reduce the length of hospitalization. However, the current status of strategies in
      supporting preterm infants throughout their feeding transition are inconsistent, and lack of
      guidelines and monitor indicators based on existing evidence.

      This project proposed a three-year plan the explore the current situation, examine effective
      strategies for care bundles, and further develop a new clinical guideline that can be
      implemented in the future. The first year of this research will use chart review among two
      neonatal intensive care units of Medical Center from Taipei and Tainan. A semi-structured
      interview and questionnaire (DSCS-N) will be used to explore nurses' knowledge, attitude and
      skills of developmental care; and the experience of caring for preterm infants during feeding
      transition in the neonatal intensive care units. In addition, gestational age, body weight,
      gavage and oral feeding amount, and special events happened during feeding will be recorded
      and analyzed.

      The second year, an experimental with a stratified random assignment and repeated measure
      design will be used with feeding transition care bundles. 120 preterm infants will be
      recruited and assigned to experimental or control group. The subjects will be fed by the
      routine care approach or by the feeding transition approach in one neonatal intensive care
      unit. Intervention components include oral stimulation and cue-based feeding during the
      transition to oral feeding. Study measures will include physical indicators, POFRAS and EFS
      during feeding to evaluate the implementation and guide further development of the clinical
      guideline.

      The third year of guideline development will follow Bowker and the National Health Insurance
      Bureau which including 5 stage. The results of this guideline can offer better
      recommendations to support preterm infants' oral development, provide cue-based feeding, and
      help them succeed in the transition to oral nutrition.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Care Provider)
measure: Preterm infant's oral feeding readiness
time frame: Change from day 1(Baseline) up to day 7 in oral stimulation phase
description: We use the Preterm Oral Feeding Readiness Assessment Scales (POFRAS) to assess preterm infants' readiness to start oral feeding. The scale comprised of 5 five categories including corrected Gestational Age, Behavioral Organization (3 item), Oral Posture (2 item), Oral Reflexes (4 item), Nonnutritive Sucking (8 item) with a total of 18 items to evaluate. Each item score from 0~2, the higher the score means that the preterm infant has better oral feeding preparation.
measure: Preterm infant's oral feeding skills
time frame: From day 1(Baseline) up to the day 30 in cue-base feeding phase
description: Using Early Feeding Skills Assessments for Preterm Infants (EFS). The Early Feeding Skills Assessments for Preterm Infants (EFS) checklist is to assess preterm infants' oral feeding readiness (before feeding; yes/no), oral feeding skill (when feeding; all/most/some/none; never/occasionally/often), oral feeding tolerance (after feeding; yes/no) and feeding descriptors(after feeding).
measure: Body weight change
time frame: Change from day 1(baseline) up to the day 200.
description: body weight change in grams
measure: hospital stay length(days)
time frame: From day 1 up to the day 200.
description: How many days from admission(birth day) to discharge(leave) hospital.
arm group label: PIOMI treat group
arm group type: Experimental
description: Preterm infant receive oral massage using the premature infant oral motor intervention (PIOMI)
arm group label: Routine care group
arm group type: No Intervention
description: Preterm infant receive routine care of neonatal intensive care unit(NICU)
intervention type: Other
intervention name: The premature infant oral motor intervention (PIOMI)
description: The premature infant oral motor intervention (PIOMI) is an oral motor program that provides assisted movement to activate muscle contraction and provides movement against resistance to build strength in the areas of the mouth necessary for feeding. It is designed to increase the maturation of neural structures, improving their ability to suck and swallow.
arm group label: PIOMI treat group
other name: Cue-based feeding
criteria: 
gender: All
minimum age: N/A
maximum age: 33 Weeks
healthy volunteers: No
last name: Mei-Chih Huang
role: Principal Investigator
affiliation: Department of Nursing, College of Medicine, National Cheng-Kung University
facility: 
country: Taiwan
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responsible party type: Sponsor
mesh term: Premature Birth