<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/NCT03026491</url>
  </required_header>
  <id_info>
    <org_study_id>EA-TEF</org_study_id>
    <nct_id>NCT03026491</nct_id>
  </id_info>
  <brief_title>Chewing in Children With Repaired Esophageal Atresia-tracheoesophageal Fistula</brief_title>
  <official_title>Chewing Function in Children With Repaired Esophageal Atresia-tracheoesophageal Fistula</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators aim to evaluate chewing function in children with repaired esophageal&#xD;
      atresia-tracheoesophageal fistula (EA-TEF). Patients with repaired EA-TEF will be evaluated&#xD;
      for age, sex, type of atresia. Each child will be required to bite and chew a standardized&#xD;
      biscuit. Chewing function will be scored with the Karaduman Chewing Performance Scale (KCPS).&#xD;
      The International Dysphagia Diet Standardisation Initiative (IDDSI) will be used to determine&#xD;
      the tolerated food texture of children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The diet of children with normal feeding skills includes a combination of liquid, semisolid&#xD;
      and/or solid foods. Chewing dysfunction (CD) in children may cause restrictions in solid food&#xD;
      intake, thereby may result in insufficient food intake and delay in growth. It is aim to&#xD;
      evaluate chewing function in children with repaired esophageal atresia-tracheoesophageal&#xD;
      fistula (EA-TEF). Patients with repaired EA-TEF will be evaluated for age, sex, type of&#xD;
      atresia. Each child will be required to bite and chew a standardized biscuit. Chewing&#xD;
      function will be scored with the Karaduman Chewing Performance Scale (KCPS). The&#xD;
      International Dysphagia Diet Standardisation Initiative (IDDSI) will be used to determine the&#xD;
      tolerated food texture of children.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">April 1, 2017</completion_date>
  <primary_completion_date type="Actual">March 1, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Chewing function will be scored with the Karaduman Chewing Performance Scale (KCPS)</measure>
    <time_frame>10 minutes</time_frame>
    <description>Chewing function will be evaluated</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Observational oral motor assessment will be performed</measure>
    <time_frame>15 minutes</time_frame>
    <description>The presence of open mouth posture, open bite, tongue thrust, high palate will be noted as ''absent'' or ''present''. The body position, hyper/hyposensitivity, jaw, lips/cheeks and tongue movements of the children will be assessed .</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">35</enrollment>
  <condition>Chewing Problem</condition>
  <arm_group>
    <arm_group_label>Children with chewing dysfunction</arm_group_label>
    <description>Descriptive characteristics including age, height, weight, transition time to additional food, meal time, number of meals, initial teething time, and number of teeth, were noted. The presence of open mouth, open bite, high palate, gag reflex, and oral hygiene were scored as absent or present as an observational oral motor assessment. Chewing evaluation was performed and scored with the Karaduman Chewing Performance Scale (KCPS). The International Dysphagia Diet Standardisation Initiative (IDDSI) was used to determine the tolerated food texture of children.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Children without chewing dysfunction</arm_group_label>
    <description>Descriptive characteristics including age, height, weight, transition time to additional food, meal time, number of meals, initial teething time, and number of teeth, were noted. The presence of open mouth, open bite, high palate, gag reflex, and oral hygiene were scored as absent or present as an observational oral motor assessment. Chewing evaluation was performed and scored with the Karaduman Chewing Performance Scale (KCPS). The International Dysphagia Diet Standardisation Initiative (IDDSI) was used to determine the tolerated food texture of children.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Chewing evaluation</intervention_name>
    <description>Each child was required to bite and chew a standardized biscuit while chewing video recording. Chewing function was scored with the Karaduman Chewing Performance Scale (KCPS).</description>
    <arm_group_label>Children with chewing dysfunction</arm_group_label>
    <arm_group_label>Children without chewing dysfunction</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children with repaired esophageal atresia-tracheoesophageal fistula&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children with repaired esophageal atresia-tracheoesophageal fistula, without airway&#xD;
             aspiration, intact airway closure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children without repaired esophageal atresia-tracheoesophageal fistula, with airway&#xD;
             aspiration, insufficient airway closure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>24 Months</minimum_age>
    <maximum_age>192 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>SELEN SEREL ARSLAN, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>January 15, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>August 8, 2017</last_update_submitted>
  <last_update_submitted_qc>August 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>SELEN SEREL ARSLAN</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal Atresia</mesh_term>
    <mesh_term>Tracheoesophageal Fistula</mesh_term>
    <mesh_term>Fistula</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03026491
org study id: EA-TEF
nct id: NCT03026491
lead sponsor: 
has dmc: Yes
The investigators aim to evaluate chewing function in children with repaired esophageal
      atresia-tracheoesophageal fistula (EA-TEF). Patients with repaired EA-TEF will be evaluated
      for age, sex, type of atresia. Each child will be required to bite and chew a standardized
      biscuit. Chewing function will be scored with the Karaduman Chewing Performance Scale (KCPS).
      The International Dysphagia Diet Standardisation Initiative (IDDSI) will be used to determine
      the tolerated food texture of children.
The diet of children with normal feeding skills includes a combination of liquid, semisolid
      and/or solid foods. Chewing dysfunction (CD) in children may cause restrictions in solid food
      intake, thereby may result in insufficient food intake and delay in growth. It is aim to
      evaluate chewing function in children with repaired esophageal atresia-tracheoesophageal
      fistula (EA-TEF). Patients with repaired EA-TEF will be evaluated for age, sex, type of
      atresia. Each child will be required to bite and chew a standardized biscuit. Chewing
      function will be scored with the Karaduman Chewing Performance Scale (KCPS). The
      International Dysphagia Diet Standardisation Initiative (IDDSI) will be used to determine the
      tolerated food texture of children.
observational model: Cohort
time perspective: Prospective
measure: Chewing function will be scored with the Karaduman Chewing Performance Scale (KCPS)
time frame: 10 minutes
description: Chewing function will be evaluated
measure: Observational oral motor assessment will be performed
time frame: 15 minutes
description: The presence of open mouth posture, open bite, tongue thrust, high palate will be noted as ''absent'' or ''present''. The body position, hyper/hyposensitivity, jaw, lips/cheeks and tongue movements of the children will be assessed .
arm group label: Children with chewing dysfunction
description: Descriptive characteristics including age, height, weight, transition time to additional food, meal time, number of meals, initial teething time, and number of teeth, were noted. The presence of open mouth, open bite, high palate, gag reflex, and oral hygiene were scored as absent or present as an observational oral motor assessment. Chewing evaluation was performed and scored with the Karaduman Chewing Performance Scale (KCPS). The International Dysphagia Diet Standardisation Initiative (IDDSI) was used to determine the tolerated food texture of children.
arm group label: Children without chewing dysfunction
description: Descriptive characteristics including age, height, weight, transition time to additional food, meal time, number of meals, initial teething time, and number of teeth, were noted. The presence of open mouth, open bite, high palate, gag reflex, and oral hygiene were scored as absent or present as an observational oral motor assessment. Chewing evaluation was performed and scored with the Karaduman Chewing Performance Scale (KCPS). The International Dysphagia Diet Standardisation Initiative (IDDSI) was used to determine the tolerated food texture of children.
intervention type: Other
intervention name: Chewing evaluation
description: Each child was required to bite and chew a standardized biscuit while chewing video recording. Chewing function was scored with the Karaduman Chewing Performance Scale (KCPS).
arm group label: Children with chewing dysfunction
arm group label: Children without chewing dysfunction
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 24 Months
maximum age: 192 Months
healthy volunteers: Accepts Healthy Volunteers
last name: SELEN SEREL ARSLAN, PhD
role: Principal Investigator
affiliation: Hacettepe University
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: SELEN SEREL ARSLAN
investigator title: Principal Investigator
mesh term: Esophageal Atresia
mesh term: Tracheoesophageal Fistula
mesh term: Fistula
sharing ipd: No