<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/NCT01675726</url>
  </required_header>
  <id_info>
    <org_study_id>2012-A00193-40</org_study_id>
    <secondary_id>2012-02</secondary_id>
    <nct_id>NCT01675726</nct_id>
  </id_info>
  <brief_title>QUALITY OF LIFE OF CHILDREN BORN VERY PRETERM AT SCHOOL-AGE</brief_title>
  <official_title>QUALITY OF LIFE OF CHILDREN BORN VERY PRETERM AT SCHOOL-AGE</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      AIMS The aims were 1) to describe the quality of life (QoL) of a cohort of children born very&#xD;
      preterm (&lt;28 weeks of gestation) aged 7 to 9 years; 2) to compare children's QoL to the QoL&#xD;
      reported by a French general population of reference. 3) to determine whether&#xD;
      socio-demographic factors, neonatal features and neurocognitive status were impacting their&#xD;
      QoL.&#xD;
&#xD;
      METHODS:&#xD;
&#xD;
        -  Multi-centre study: 6 French level three perinatal care units (Marseille, Montpellier,&#xD;
           Nantes, Nîmes, Nice and Rouen).&#xD;
&#xD;
        -  Inclusion criteria: all infants born before 28 weeks of gestation between January 2005&#xD;
           and December 2007, from 7 to 9 years old of age at the time of evaluation.&#xD;
&#xD;
        -  Written agreement to participate: collected from parents.&#xD;
&#xD;
        -  Data collection: reports of children's QoL by children and their parents (using&#xD;
           standardized validated questionnaires); clinical information about the children,&#xD;
           obtained through a medical examination; children neurocognitive profile.&#xD;
&#xD;
        -  Duration of inclusion: over 24 months.&#xD;
&#xD;
        -  Population: of the six structures, approximately 300 children will be evaluated&#xD;
           consistent with the active files of the participating centres and an attrition rate of&#xD;
           30%.&#xD;
&#xD;
      PERSPECTIVES This is one of the first studies to collect self-reported data on quality of&#xD;
      life of school-age children (7-9 years) born before 28 weeks of gestation. A better&#xD;
      understanding of demographic and clinical determinants of QOL of school-age very preterm&#xD;
      children may help clinicians involved in the care of these children in their ethical and&#xD;
      medical considerations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>data on quality of life of school-age children born prematurely</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>better understanding of demographic and clinical determinants of QOL of school-age</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">350</enrollment>
  <condition>CHILDREN BORN VERY PRETERM AT SCHOOL-AGE</condition>
  <arm_group>
    <arm_group_label>quality of life</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionary on quality of life</intervention_name>
    <arm_group_label>quality of life</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Child been born between 01/01/2005 and the inclusive 31/12/2007,&#xD;
&#xD;
          -  Extreme premature born Child before 28 weeks of amenorrhea,&#xD;
&#xD;
          -  Child hospitalized after the birth in a level maternity 3 (been born &quot; inborn &quot; or &quot;&#xD;
             outborn &quot;)&#xD;
&#xD;
          -  Not dead Child,&#xD;
&#xD;
          -  Child not presenting a cerebral palsy,&#xD;
&#xD;
          -  Child capable of answering a questionnaire in French language,&#xD;
&#xD;
          -  Child among whom the parents(relatives) or the legal representatives accepted the&#xD;
             principle of the participation in this study, and having signed a consent,&#xD;
&#xD;
          -  Child granting to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child died between the birth and dates her(it) evaluation,&#xD;
&#xD;
          -  Child presenting a cerebral palsy&#xD;
&#xD;
          -  Child among whom the parents(relatives) or the legal representatives refused that&#xD;
             their child participates in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>9 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>BERNARD BELAIGUES</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique Hopitaux De Marseille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assistance Publique Hopitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13354</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>August 29, 2017</last_update_submitted>
  <last_update_submitted_qc>August 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2017</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>
  <!-- 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/NCT01675726
org study id: 2012-A00193-40
secondary id: 2012-02
nct id: NCT01675726
lead sponsor: 
has dmc: No
AIMS The aims were 1) to describe the quality of life (QoL) of a cohort of children born very
      preterm (<28 weeks of gestation) aged 7 to 9 years; 2) to compare children's QoL to the QoL
      reported by a French general population of reference. 3) to determine whether
      socio-demographic factors, neonatal features and neurocognitive status were impacting their
      QoL.

      METHODS:

        -  Multi-centre study: 6 French level three perinatal care units (Marseille, Montpellier,
           Nantes, Nîmes, Nice and Rouen).

        -  Inclusion criteria: all infants born before 28 weeks of gestation between January 2005
           and December 2007, from 7 to 9 years old of age at the time of evaluation.

        -  Written agreement to participate: collected from parents.

        -  Data collection: reports of children's QoL by children and their parents (using
           standardized validated questionnaires); clinical information about the children,
           obtained through a medical examination; children neurocognitive profile.

        -  Duration of inclusion: over 24 months.

        -  Population: of the six structures, approximately 300 children will be evaluated
           consistent with the active files of the participating centres and an attrition rate of
           30%.

      PERSPECTIVES This is one of the first studies to collect self-reported data on quality of
      life of school-age children (7-9 years) born before 28 weeks of gestation. A better
      understanding of demographic and clinical determinants of QOL of school-age very preterm
      children may help clinicians involved in the care of these children in their ethical and
      medical considerations.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: data on quality of life of school-age children born prematurely
time frame: 3 years
measure: better understanding of demographic and clinical determinants of QOL of school-age
time frame: 3 years
arm group label: quality of life
arm group type: Other
intervention type: Other
intervention name: questionary on quality of life
arm group label: quality of life
criteria: 
gender: All
minimum age: 7 Years
maximum age: 9 Years
healthy volunteers: No
last name: BERNARD BELAIGUES
role: Study Director
affiliation: Assistance Publique Hopitaux De Marseille
facility: 
country: France
responsible party type: Sponsor
mesh term: Premature Birth