<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/NCT02988570</url>
  </required_header>
  <id_info>
    <org_study_id>2016/338/HP</org_study_id>
    <nct_id>NCT02988570</nct_id>
  </id_info>
  <brief_title>Study on the Phenotype of Language in Preterm Born Children at 5 Years of Age</brief_title>
  <acronym>EPILANG2</acronym>
  <official_title>Study on the Phenotype of Language in Preterm Born Children at 5 Years of Age</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Rouen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Rouen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In recent years, several studies confirm that some of preterm children have language&#xD;
      developmental disabilities, in production, in comprehension, or in written language. These&#xD;
      language impairments lead to learning disabilities. There are, however, contradictions&#xD;
      concerning the origin and nature of language dysfunctions. Some studies find lexical&#xD;
      disorders (number of words used by the child), others preferentially phonological disorders&#xD;
      (sounds used in the language), others also disorders of the morphosyntaxe (organization of&#xD;
      the sentences) and fragilities that affect pragmatics (understanding situations).&#xD;
&#xD;
      The computer-evaluation of the language is carried out at five and a half year coupled with&#xD;
      the medical and neuropsychological examinations. The language assessment lasts 30 to 45&#xD;
      minutes per child. It is carried out using a laptop computer that allows the submission of&#xD;
      stimuli and recording of the child's responses. The language evaluation scale is the battery&#xD;
      CléA (Pasquet F et al, 2014), standardized reference tool for the realization of a language&#xD;
      evaluation. The assessment includes three tests: comprehension of words and phrases,&#xD;
      production of words and phrases, and judgment of sentences. Each time, the child sees images&#xD;
      and hears words or phrases. Sometimes he has to say what he sees on the computer screen.&#xD;
&#xD;
      As usual, a speech-language assessment is not carried out, routinely, at the age of 5 years&#xD;
      in the context of the follow-up of children born very preterm.&#xD;
&#xD;
      The evaluation proposed to the child in this research will be carried out at a significant&#xD;
      period of development, before writing. This assessment will not only assess the structure of&#xD;
      the child's language, but also determine if there are possible difficulties in learning to&#xD;
      read and write.&#xD;
&#xD;
      The expected benefits for the health of the children included in the trial therefore concern&#xD;
      the detection or characterization of any developmental fragilities affecting the language.&#xD;
      These screenings or characterizations will make it possible to advocate a speech&#xD;
      rehabilitation if necessary.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 10, 2016</start_date>
  <completion_date type="Actual">March 31, 2017</completion_date>
  <primary_completion_date type="Actual">March 31, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of comprehension of words and phrases level</measure>
    <time_frame>Day 1</time_frame>
    <description>A computer-based language evaluation battery (Cléa) comprising standardized test to evaluate comprehension of words and phrases will be used.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of production of words and phrases level</measure>
    <time_frame>Day 1</time_frame>
    <description>A computer-based language evaluation battery (Cléa) comprising standardized test to evaluate production of words and phrases level will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of judgment of sentences level</measure>
    <time_frame>Day 1</time_frame>
    <description>A computer-based language evaluation battery (Cléa) comprising standardized test to evaluate judgment of sentences level will be used.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Preterm Children</condition>
  <arm_group>
    <arm_group_label>children born very preterm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A computer-evaluation of the language will be done for children born very preterm preterm in 2011 in the region of Haute-Normandie in France</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>computer-evaluation of the language</intervention_name>
    <description>A computer-evaluation of the language will be done for children born very preterm preterm in 2011 in the region of Haute-Normandie in France</description>
    <arm_group_label>children born very preterm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children born very preterm in 2011 in the region of Haute-Normandie in France&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stéphane MARRET, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rouen University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rouen University Hospital</name>
      <address>
        <city>Rouen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>April 26, 2018</last_update_submitted>
  <last_update_submitted_qc>April 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2018</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>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>


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/NCT02988570
org study id: 2016/338/HP
nct id: NCT02988570
lead sponsor: 
has dmc: No
In recent years, several studies confirm that some of preterm children have language
      developmental disabilities, in production, in comprehension, or in written language. These
      language impairments lead to learning disabilities. There are, however, contradictions
      concerning the origin and nature of language dysfunctions. Some studies find lexical
      disorders (number of words used by the child), others preferentially phonological disorders
      (sounds used in the language), others also disorders of the morphosyntaxe (organization of
      the sentences) and fragilities that affect pragmatics (understanding situations).

      The computer-evaluation of the language is carried out at five and a half year coupled with
      the medical and neuropsychological examinations. The language assessment lasts 30 to 45
      minutes per child. It is carried out using a laptop computer that allows the submission of
      stimuli and recording of the child's responses. The language evaluation scale is the battery
      CléA (Pasquet F et al, 2014), standardized reference tool for the realization of a language
      evaluation. The assessment includes three tests: comprehension of words and phrases,
      production of words and phrases, and judgment of sentences. Each time, the child sees images
      and hears words or phrases. Sometimes he has to say what he sees on the computer screen.

      As usual, a speech-language assessment is not carried out, routinely, at the age of 5 years
      in the context of the follow-up of children born very preterm.

      The evaluation proposed to the child in this research will be carried out at a significant
      period of development, before writing. This assessment will not only assess the structure of
      the child's language, but also determine if there are possible difficulties in learning to
      read and write.

      The expected benefits for the health of the children included in the trial therefore concern
      the detection or characterization of any developmental fragilities affecting the language.
      These screenings or characterizations will make it possible to advocate a speech
      rehabilitation if necessary.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Evaluation of comprehension of words and phrases level
time frame: Day 1
description: A computer-based language evaluation battery (Cléa) comprising standardized test to evaluate comprehension of words and phrases will be used.
measure: Evaluation of production of words and phrases level
time frame: Day 1
description: A computer-based language evaluation battery (Cléa) comprising standardized test to evaluate production of words and phrases level will be used.
measure: Evaluation of judgment of sentences level
time frame: Day 1
description: A computer-based language evaluation battery (Cléa) comprising standardized test to evaluate judgment of sentences level will be used.
arm group label: children born very preterm
arm group type: Experimental
description: A computer-evaluation of the language will be done for children born very preterm preterm in 2011 in the region of Haute-Normandie in France
intervention type: Behavioral
intervention name: computer-evaluation of the language
description: A computer-evaluation of the language will be done for children born very preterm preterm in 2011 in the region of Haute-Normandie in France
arm group label: children born very preterm
criteria: 
gender: All
minimum age: 5 Years
maximum age: 6 Years
healthy volunteers: No
last name: Stéphane MARRET, Pr
role: Principal Investigator
affiliation: Rouen University Hospital
facility: 
country: France
responsible party type: Sponsor
mesh term: Premature Birth
sharing ipd: No