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/NCT05992181</url>
    </required_header>
    <id_info>
      <org_study_id>2023-A01290-45</org_study_id>
      <nct_id>NCT05992181</nct_id>
    </id_info>
    <brief_title>Development of a Digital Tool for the Individualization of Speech Therapy for Premature Newborns</brief_title>
    <acronym>NEORTHO</acronym>
    <official_title>Development of a Digital Tool for the Individualization of Speech Therapy for Premature Newborns</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Sud Francilien</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Hospitalier Sud Francilien</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 study concerns the creation and implementation of a digital tool presenting the various&#xD;
        orofacial stimuli that can be offered to premature newborns. This app is intended for&#xD;
        parents, to allow them to play a more active role in their child's care, and provide them&#xD;
        with special time with their child. The notion of pleasure is very important to us, and it's&#xD;
        vital to help parents rediscover this feeling with their child. Different profiles will be&#xD;
        created to individualize our recommendations, facilitate the understanding of orofacial&#xD;
        stimuli, make them more concrete than drawings, and provide care adapted to each patient and&#xD;
        improve the development of newborns through more regular orofacial stimulation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Two groups will be formed:&#xD;
  &#xD;
        Group A - control: receiving the speech therapy currently in place in the department.&#xD;
  &#xD;
        Group B - experimental: will receive the same care as the first group, plus access to the&#xD;
        videos and the introduction of early orofacial stimulation.&#xD;
  &#xD;
        Group B: First, an initial assessment will be performed in speech-language pathology of the&#xD;
        oro-myofunctional and oral functions of the newborn. This will determine which orofacial&#xD;
        solicitations to give to the baby and create in the patient's profile.&#xD;
  &#xD;
        Parents will be trained in orofacial stimulation and will be coached during the first&#xD;
        sessions. When parents are ready, access will be given to their personal space on the&#xD;
        application. Appointments will be scheduled to remodel the treatment if necessary. Sucking&#xD;
        (ECEPAB), feeding (PIBBS) and behavioural (EDIN) abilities will be assessed. Parents will be&#xD;
        asked to fill out a questionnaire about their feelings.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 30, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Milk taken daily</measure>
      <time_frame>up to 3 months</time_frame>
      <description>Percentage of the amount of milk taken daily (measure taken once per week throughout the study).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Behavior scale for the analysis of oral reflexes and suction reflexes (MIAM questionnaire)</measure>
      <time_frame>Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90</time_frame>
      <description>Analysis of oral and suction reflexes : global observation and functional assessment. (0=absent to 2=normal)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Feeding behavior scale for premature infants moving to bottle-feeding (ECEPAB questionnaire</measure>
      <time_frame>Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90</time_frame>
      <description>feeding behavior scale for premature infants moving to bottle-feeding (0=absent to 18=normal)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Milk flower (PIBBS questionnaire)</measure>
      <time_frame>Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90</time_frame>
      <description>global observation and functional assessment (0=absent to 20=normal)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Newborn Pain and Discomfort Scale (EDIN questionnaire)</measure>
      <time_frame>Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90</time_frame>
      <description>Newborn Pain and Discomfort Scale (0=normal to 15=painful)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>anxiety questionnaire</measure>
      <time_frame>Day 0, Day 30, Day 60, Day 90</time_frame>
      <description>anxiety questionnaire for the parents (0=relaxed to 2=anxious)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>satisfaction questionnaire</measure>
      <time_frame>Day 90</time_frame>
      <description>satisfaction questionnaire for the application (0=unsatisfied to 3=satisfied)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Premature Birth</condition>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>With the speech therapy already in place in the department.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>With the speech therapy already in place in the department, plus access to videos and the introduction of early orofacial stimulation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>NEORTHO</intervention_name>
      <description>early orofacial stimulation</description>
      <arm_group_label>experimental group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Child born prematurely before 29 weeks of amenorrhea (SA).&#xD;
  &#xD;
            -  Alive for minimum 24h.&#xD;
  &#xD;
            -  Holders of parental authority who have been informed of the study and have not&#xD;
               objected.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Child born after 29 weeks of amenorrhea.&#xD;
  &#xD;
            -  with a genetic or severe neurological pathology or withdrawal syndrome.&#xD;
  &#xD;
            -  with a vital prognosis.&#xD;
  &#xD;
            -  whose family home is too far from the service.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>24 Hours</minimum_age>
      <maximum_age>3 Months</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Caroline BALANCON</last_name>
      <phone>01 61 69 37 31</phone>
      <email>caroline.balancon@chsf.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Caroline TOURTE</last_name>
      <phone>01 61 69 31 50</phone>
      <email>caroline.tourte@chsf.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Centre Hospitalier Sud Francilien</name>
        <address>
          <city>Corbeil-Essonnes</city>
          <zip>91106</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Caroline BALANCON</last_name>
        <phone>01 61 69 37 31</phone>
        <email>caroline.balancon@chsf.fr</email>
      </contact>
      <investigator>
        <last_name>Caroline BALANCON</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Communication Disorders</mesh_term>
      <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/NCT05992181
  org study id: 2023-A01290-45
  nct id: NCT05992181
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study concerns the creation and implementation of a digital tool presenting the various
        orofacial stimuli that can be offered to premature newborns. This app is intended for
        parents, to allow them to play a more active role in their child's care, and provide them
        with special time with their child. The notion of pleasure is very important to us, and it's
        vital to help parents rediscover this feeling with their child. Different profiles will be
        created to individualize our recommendations, facilitate the understanding of orofacial
        stimuli, make them more concrete than drawings, and provide care adapted to each patient and
        improve the development of newborns through more regular orofacial stimulation.
  Two groups will be formed:
  
        Group A - control: receiving the speech therapy currently in place in the department.
  
        Group B - experimental: will receive the same care as the first group, plus access to the
        videos and the introduction of early orofacial stimulation.
  
        Group B: First, an initial assessment will be performed in speech-language pathology of the
        oro-myofunctional and oral functions of the newborn. This will determine which orofacial
        solicitations to give to the baby and create in the patient's profile.
  
        Parents will be trained in orofacial stimulation and will be coached during the first
        sessions. When parents are ready, access will be given to their personal space on the
        application. Appointments will be scheduled to remodel the treatment if necessary. Sucking
        (ECEPAB), feeding (PIBBS) and behavioural (EDIN) abilities will be assessed. Parents will be
        asked to fill out a questionnaire about their feelings.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Milk taken daily
  time frame: up to 3 months
  description: Percentage of the amount of milk taken daily (measure taken once per week throughout the study).
  measure: Behavior scale for the analysis of oral reflexes and suction reflexes (MIAM questionnaire)
  time frame: Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90
  description: Analysis of oral and suction reflexes : global observation and functional assessment. (0=absent to 2=normal)
  measure: Feeding behavior scale for premature infants moving to bottle-feeding (ECEPAB questionnaire
  time frame: Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90
  description: feeding behavior scale for premature infants moving to bottle-feeding (0=absent to 18=normal)
  measure: Milk flower (PIBBS questionnaire)
  time frame: Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90
  description: global observation and functional assessment (0=absent to 20=normal)
  measure: Newborn Pain and Discomfort Scale (EDIN questionnaire)
  time frame: Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90
  description: Newborn Pain and Discomfort Scale (0=normal to 15=painful)
  measure: anxiety questionnaire
  time frame: Day 0, Day 30, Day 60, Day 90
  description: anxiety questionnaire for the parents (0=relaxed to 2=anxious)
  measure: satisfaction questionnaire
  time frame: Day 90
  description: satisfaction questionnaire for the application (0=unsatisfied to 3=satisfied)
  arm group label: control group
  arm group type: No Intervention
  description: With the speech therapy already in place in the department.
  arm group label: experimental group
  arm group type: Experimental
  description: With the speech therapy already in place in the department, plus access to videos and the introduction of early orofacial stimulation.
  intervention type: Other
  intervention name: NEORTHO
  description: early orofacial stimulation
  arm group label: experimental group
  criteria: 
  gender: All
  minimum age: 24 Hours
  maximum age: 3 Months
  healthy volunteers: No
  last name: Caroline BALANCON
  phone: 01 61 69 37 31
  email: caroline.balancon@chsf.fr
  last name: Caroline TOURTE
  phone: 01 61 69 31 50
  email: caroline.tourte@chsf.fr
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Communication Disorders
  mesh term: Premature Birth
  sharing ipd: No