<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/NCT01732978</url>
  </required_header>
  <id_info>
    <org_study_id>1208093</org_study_id>
    <nct_id>NCT01732978</nct_id>
  </id_info>
  <brief_title>Are Parents Privileged Listeners Their Baby ?</brief_title>
  <acronym>BABIES_CRY</acronym>
  <official_title>Are Parents Privileged Listeners Their Baby ?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Saint Etienne</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The crying baby is a sound signal including information relating to this individual identity&#xD;
      or related to its physiological or motivational state.&#xD;
&#xD;
      The objective of the study is to determine the implementation of the recognition of&#xD;
      individual tone of the baby by his parents and acoustic modulation of the baby based on&#xD;
      parental response.&#xD;
&#xD;
      The detailed study of the acoustic structure of crying and analysis of parental perception&#xD;
      will determine the dynamics during the first weeks of life of this recognition, and the&#xD;
      influence of factors such as parental presence, or breastfeeding .&#xD;
&#xD;
      For this study is organized in three stages: first, the recording of the baby's crying&#xD;
      Secondly, a listening test parental soundtracks and third analysis of the acoustic structure&#xD;
      of crying and parental response.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Crying recorded</measure>
    <time_frame>Second day of life of the parent's child</time_frame>
    <description>The acoustic structure of crying recorded the first days of life will be analyzed and aims to characterize an individual signature and the dynamic function of time of this structure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biological correlation</measure>
    <time_frame>Second day of life of parents' child</time_frame>
    <description>The acoustic structure of crying will also be studied to establish a possible correlation with biological parameters baby</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Newborn</condition>
  <arm_group>
    <arm_group_label>Babies</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Any child born in the University Hospital of Saint Etienne (inborn) whatever its term birth, hospitalized in a neonatal unit at the time of registration (after 37 weeks of gestation for preterm infants) or maternity</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Crying record</intervention_name>
    <description>Recording spontaneous crying is as soon as possible after birth. Crying is recorded twice during the first week of life.&#xD;
Listening tests:&#xD;
Tests will be conducted playbacks with the father and mother separately, and with a staff</description>
    <arm_group_label>Babies</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  born in the University Hospital of Saint Etienne (inborn) whatever its term birth&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Congenital oropharyngeal tract preventing vocalization physiological newborn&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>1 Week</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicolas MATHEVON, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Université Jean Monnet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Saint-Etienne</name>
      <address>
        <city>Saint-etienne</city>
        <zip>42000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>November 20, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <last_update_submitted>October 22, 2018</last_update_submitted>
  <last_update_submitted_qc>October 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Crying record</keyword>
  <keyword>Newborn</keyword>
  <!-- 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/NCT01732978
org study id: 1208093
nct id: NCT01732978
lead sponsor: 
has dmc: No
The crying baby is a sound signal including information relating to this individual identity
      or related to its physiological or motivational state.

      The objective of the study is to determine the implementation of the recognition of
      individual tone of the baby by his parents and acoustic modulation of the baby based on
      parental response.

      The detailed study of the acoustic structure of crying and analysis of parental perception
      will determine the dynamics during the first weeks of life of this recognition, and the
      influence of factors such as parental presence, or breastfeeding .

      For this study is organized in three stages: first, the recording of the baby's crying
      Secondly, a listening test parental soundtracks and third analysis of the acoustic structure
      of crying and parental response.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Crying recorded
time frame: Second day of life of the parent's child
description: The acoustic structure of crying recorded the first days of life will be analyzed and aims to characterize an individual signature and the dynamic function of time of this structure.
measure: Biological correlation
time frame: Second day of life of parents' child
description: The acoustic structure of crying will also be studied to establish a possible correlation with biological parameters baby
arm group label: Babies
arm group type: Other
description: Any child born in the University Hospital of Saint Etienne (inborn) whatever its term birth, hospitalized in a neonatal unit at the time of registration (after 37 weeks of gestation for preterm infants) or maternity
intervention type: Behavioral
intervention name: Crying record
description: Recording spontaneous crying is as soon as possible after birth. Crying is recorded twice during the first week of life.
Listening tests:
Tests will be conducted playbacks with the father and mother separately, and with a staff
arm group label: Babies
criteria: 
gender: All
minimum age: N/A
maximum age: 1 Week
healthy volunteers: Accepts Healthy Volunteers
last name: Nicolas MATHEVON, PhD
role: Study Chair
affiliation: Université Jean Monnet
facility: 
country: France
responsible party type: Sponsor