<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/NCT03262194</url>
  </required_header>
  <id_info>
    <org_study_id>P/2017/314</org_study_id>
    <nct_id>NCT03262194</nct_id>
  </id_info>
  <brief_title>Relevance of Gastric Aspirate in HCMV Detection</brief_title>
  <acronym>VIRULAG</acronym>
  <official_title>Relevance of Gastric Aspirate in HCMV Detection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Besancon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Besancon</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>
      Human cytomegalovirus (CMV) is the leading cause of neonatal viral infection and can have a&#xD;
      significant impact on the neurosensory development of newborns and especially premature&#xD;
      infants. CMV infection can result from materno-fetal transmission during pregnancy&#xD;
      (congenital infection) or postnatal transmission. The prevalence of congenital CMV infection&#xD;
      in the newborn is estimated to be between 0.1 and 0.5%. Among the newborns in utero infected&#xD;
      by CMV, it is estimated that 10-15% will present symptoms at birth (hypoacousia / unilateral&#xD;
      or bilateral deafness, microcephaly, chorioretinitis, psychomotor retardation, etc.) and 0.5%&#xD;
      of them will die. 20% of infected infants, mainly symptomatic newborns, suffer permanent&#xD;
      sequelae, mainly loss of hearing. Many asymptomatic children at birth will present hearing&#xD;
      loss and other delayed neurological complications. A progressive neurosensory hearing loss&#xD;
      may develop for 13-15% of asymptomatic newborns at birth. Deafness is bilateral in 50% of&#xD;
      cases, severe in more than 50% of cases, and its occurrence is often delayed. The hearing&#xD;
      loss has a significant impact on the future life of the child, mainly on language acquisition&#xD;
      and school performance.&#xD;
&#xD;
      A systematic CMV screening is not currently recommended at birth due to the frequency of&#xD;
      asymptomatic forms, difficulty in fetal diagnosis and prognosis, lack of consensus for&#xD;
      preventive and curative treatment of the infection. New treatments are being evaluated and&#xD;
      encouraging results could revive the debate.&#xD;
&#xD;
      PCR from urine is the gold standard for the diagnosis of CMV infection. Urine collection is&#xD;
      not systematic in newborns and its realization can sometimes be difficult. On the other hand,&#xD;
      in children at risk (hypotrophy, prematurity, infectious risks, fetal distress or respiratory&#xD;
      distress at birth), gastric aspiration is systematically performed at birth to overcome&#xD;
      obstruction of the upper aero-digestive tract, to prevent oesophageal atresia, to avoid&#xD;
      inhalation by reflux and sometimes to make a bacteriological diagnosis.&#xD;
&#xD;
      Our hypothesis is that this liquid could be used for the detection of CMV infection without&#xD;
      adding any invasive action in newborns. Ultimately, gastric aspirate could allow for routine&#xD;
      CMV screening in children at risk and thus allow for appropriate care by nursing staff.The&#xD;
      occurrence of immediate or delayed sensory sequelae in these children would be then limited.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The introduction of new recommendations for early neonatal infection has drastically reduced&#xD;
    the need for gastric aspiration at birth.&#xD;
  </why_stopped>
  <start_date type="Actual">September 19, 2017</start_date>
  <completion_date type="Actual">June 7, 2019</completion_date>
  <primary_completion_date type="Actual">June 7, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Match between gastral aspirate PCR results and urine PCR results</measure>
    <time_frame>day 7</time_frame>
    <description>Match between gastral aspirate polymerase chain reaction results and urine polymerase chain reaction results</description>
  </primary_outcome>
  <enrollment type="Actual">44</enrollment>
  <condition>Cytomegalovirus Infections</condition>
  <condition>Hypotrophic Newborns</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Hypotrophic newborns&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria of the newborn:&#xD;
&#xD;
        - Child born in maternity and / or child hospitalized in the Neonatal Médicine Department&#xD;
        of the University Hospital of Besançon for which a urine sample (minimum volume = 0.5 mL)&#xD;
        and a gastric aspiration fluid sample (minimum volume = 0.7mL) were collected (regardless&#xD;
        of gender, birth weight or pathology presented at admission).&#xD;
&#xD;
        Exclusion Criteria of the newborn:&#xD;
&#xD;
          -  Child died before the sampling&#xD;
&#xD;
          -  A volume of gastric aspiration fluid dedicated to the study less than 0.7 mL.&#xD;
&#xD;
          -  An impossible collection of urine (malformation, skin irritation of the perineum,&#xD;
             contamination with meconium).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Minute</minimum_age>
    <maximum_age>7 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thiriez Gérard, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire de Besançon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chu Besancon</name>
      <address>
        <city>Besancon</city>
        <zip>25000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>July 28, 2023</last_update_submitted>
  <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 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>Cytomegalovirus Infections</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/NCT03262194
org study id: P/2017/314
nct id: NCT03262194
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Human cytomegalovirus (CMV) is the leading cause of neonatal viral infection and can have a
      significant impact on the neurosensory development of newborns and especially premature
      infants. CMV infection can result from materno-fetal transmission during pregnancy
      (congenital infection) or postnatal transmission. The prevalence of congenital CMV infection
      in the newborn is estimated to be between 0.1 and 0.5%. Among the newborns in utero infected
      by CMV, it is estimated that 10-15% will present symptoms at birth (hypoacousia / unilateral
      or bilateral deafness, microcephaly, chorioretinitis, psychomotor retardation, etc.) and 0.5%
      of them will die. 20% of infected infants, mainly symptomatic newborns, suffer permanent
      sequelae, mainly loss of hearing. Many asymptomatic children at birth will present hearing
      loss and other delayed neurological complications. A progressive neurosensory hearing loss
      may develop for 13-15% of asymptomatic newborns at birth. Deafness is bilateral in 50% of
      cases, severe in more than 50% of cases, and its occurrence is often delayed. The hearing
      loss has a significant impact on the future life of the child, mainly on language acquisition
      and school performance.

      A systematic CMV screening is not currently recommended at birth due to the frequency of
      asymptomatic forms, difficulty in fetal diagnosis and prognosis, lack of consensus for
      preventive and curative treatment of the infection. New treatments are being evaluated and
      encouraging results could revive the debate.

      PCR from urine is the gold standard for the diagnosis of CMV infection. Urine collection is
      not systematic in newborns and its realization can sometimes be difficult. On the other hand,
      in children at risk (hypotrophy, prematurity, infectious risks, fetal distress or respiratory
      distress at birth), gastric aspiration is systematically performed at birth to overcome
      obstruction of the upper aero-digestive tract, to prevent oesophageal atresia, to avoid
      inhalation by reflux and sometimes to make a bacteriological diagnosis.

      Our hypothesis is that this liquid could be used for the detection of CMV infection without
      adding any invasive action in newborns. Ultimately, gastric aspirate could allow for routine
      CMV screening in children at risk and thus allow for appropriate care by nursing staff.The
      occurrence of immediate or delayed sensory sequelae in these children would be then limited.
observational model: Case-Only
time perspective: Prospective
measure: Match between gastral aspirate PCR results and urine PCR results
time frame: day 7
description: Match between gastral aspirate polymerase chain reaction results and urine polymerase chain reaction results
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Minute
maximum age: 7 Days
healthy volunteers: No
last name: Thiriez Gérard, MD PhD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire de Besançon
facility: 
country: France
responsible party type: Sponsor
mesh term: Cytomegalovirus Infections
sharing ipd: No