<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/NCT03830580</url>
  </required_header>
  <id_info>
    <org_study_id>CHARY-TARDY 2018</org_study_id>
    <nct_id>NCT03830580</nct_id>
  </id_info>
  <brief_title>Benefit of Singing in the Care of Premature Children Undergoing Screening for Retinopathy of Prematurity in the Neonatology and Neonatal Resuscitation Unit of the Dijon University Hospital</brief_title>
  <acronym>Voix Chantée</acronym>
  <official_title>Benefit of Singing in the Care of Premature Children Undergoing Screening for Retinopathy of Prematurity in the Neonatology and Neonatal Resuscitation Unit of the Dijon University Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      As part of the regular procedure for premature births, premature infants undergo several&#xD;
      screening examinations, including an examination of the fundus. This examination seeks to&#xD;
      establish whether the infant has retinopathy of prematurity. This disease affects the vessels&#xD;
      of the retina of the eye, especially in prematurely born children, and can lead to serious&#xD;
      complications such as blindness if it is not treated in time.&#xD;
&#xD;
      The purpose of this study is to assess the discomfort caused by the screening in order to&#xD;
      improve practices. To do this, the investigators would like to evaluate whether soft auditory&#xD;
      stimulation, more precisely a person singing, would improve the children's level of comfort&#xD;
      during the examination.&#xD;
&#xD;
      To do this, the participating children will be divided into 2 groups:&#xD;
&#xD;
        -  The &quot;Singing&quot; group will receive the usual comfort treatments (placed in a 'nest',&#xD;
           pacifier and sugar water) and a trained professional will sing a lullaby or nursery&#xD;
           rhyme at the same time&#xD;
&#xD;
        -  control group will receive the usual comfort care (placed in a 'nest', pacifier and&#xD;
           sugar water) The child's head and entire body will be filmed, which will allow an&#xD;
           evaluator to assess the child's comfort.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 6, 2019</start_date>
  <completion_date type="Anticipated">February 2020</completion_date>
  <primary_completion_date type="Anticipated">February 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acute pain assessed by the PIPP (Premature Infant Pain Profile) scale</measure>
    <time_frame>During the examination</time_frame>
    <description>The children's faces and bodies will be filmed - without sound - during the examination. The nurse who examines the fundus will start and finish the video recording.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Prematurity</condition>
  <condition>Eye Fundus</condition>
  <arm_group>
    <arm_group_label>Sung voice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Positive stimulation (singing)</intervention_name>
    <description>A nurse or assistant trained in singing with an operal singer sings a lullaby She sits next to the incubator and sings from the time the sucrose is administered (2 minutes before the fundus exams is performed) until the end of the examination - taking into account the child's reaction</description>
    <arm_group_label>Sung voice</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infant born prematurely before the end of 31 weeks of amenorrhoea and/or with a birth&#xD;
             weight of less than 1250g&#xD;
&#xD;
          -  Infant in whom a first screening examination (fundus) for retinopathy of prematurity&#xD;
             (i.e. around 32 WA) must be carried out according to term by hospital protocol&#xD;
&#xD;
          -  Infant hospitalized in the neonatal paediatrics and intensive care unit of the Dijon&#xD;
             University Hospital&#xD;
&#xD;
          -  Infant affiliated to the national medical insurance system&#xD;
&#xD;
          -  Oral agreement of one of the two parents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infants with contraindications to the use of Algopedol® 24% sugar solution,&#xD;
             NEOSYNEPHRINE 2.5% mydriatic eye drops for pupillary dilatation, MYDRIATICUM 0.5%&#xD;
             mydriatic eye drops for pupillary dilatation and OXYBUPROCAINE analgesic eye drops&#xD;
&#xD;
          -  Infant with known deafness and no hearing aid&#xD;
&#xD;
          -  Premature infant in critical condition&#xD;
&#xD;
          -  Infant with hemodynamic and clinical instability making it impossible to perform the&#xD;
             fundus examination because of the risk of decompensation&#xD;
&#xD;
          -  Parent refuses the videotaping&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>4 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Anne-Cécile CHARY-TARDY</last_name>
    <phone>03.80.29.33.62</phone>
    <email>annececile.charytardy@chu-dijon.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne-Cécile CHARY-TARDY</last_name>
      <phone>03.80.29.33.62</phone>
      <email>annececile.charytardy@chu-dijon.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>April 16, 2019</last_update_submitted>
  <last_update_submitted_qc>April 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2019</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>Retinopathy of Prematurity</mesh_term>
    <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/NCT03830580
org study id: CHARY-TARDY 2018
nct id: NCT03830580
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
As part of the regular procedure for premature births, premature infants undergo several
      screening examinations, including an examination of the fundus. This examination seeks to
      establish whether the infant has retinopathy of prematurity. This disease affects the vessels
      of the retina of the eye, especially in prematurely born children, and can lead to serious
      complications such as blindness if it is not treated in time.

      The purpose of this study is to assess the discomfort caused by the screening in order to
      improve practices. To do this, the investigators would like to evaluate whether soft auditory
      stimulation, more precisely a person singing, would improve the children's level of comfort
      during the examination.

      To do this, the participating children will be divided into 2 groups:

        -  The "Singing" group will receive the usual comfort treatments (placed in a 'nest',
           pacifier and sugar water) and a trained professional will sing a lullaby or nursery
           rhyme at the same time

        -  control group will receive the usual comfort care (placed in a 'nest', pacifier and
           sugar water) The child's head and entire body will be filmed, which will allow an
           evaluator to assess the child's comfort.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Acute pain assessed by the PIPP (Premature Infant Pain Profile) scale
time frame: During the examination
description: The children's faces and bodies will be filmed - without sound - during the examination. The nurse who examines the fundus will start and finish the video recording.
arm group label: Sung voice
arm group type: Experimental
arm group label: Control
arm group type: No Intervention
intervention type: Other
intervention name: Positive stimulation (singing)
description: A nurse or assistant trained in singing with an operal singer sings a lullaby She sits next to the incubator and sings from the time the sucrose is administered (2 minutes before the fundus exams is performed) until the end of the examination - taking into account the child's reaction
arm group label: Sung voice
criteria: 
gender: All
minimum age: 1 Month
maximum age: 4 Months
healthy volunteers: No
last name: Anne-Cécile CHARY-TARDY
phone: 03.80.29.33.62
email: annececile.charytardy@chu-dijon.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Retinopathy of Prematurity
mesh term: Premature Birth