<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/NCT03270410</url>
  </required_header>
  <id_info>
    <org_study_id>35RC15_3012</org_study_id>
    <nct_id>NCT03270410</nct_id>
  </id_info>
  <brief_title>Design of a Non-invasive Multi-modal Neonatal Monitoring System</brief_title>
  <acronym>VARI-NEONAT</acronym>
  <official_title>Design of a Non-invasive Multi-modal Neonatal Monitoring System: Preliminary Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</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>
      This is a preliminary study whose objectives are to define the clinical use cases and the&#xD;
      constraints of the implementation of a multi-sensor image-sound system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      300 000 newborns per year are hospitalized in European neonatal units in the post-natal&#xD;
      period. This is a critical period for neurobehavioral development and the establishment of an&#xD;
      optimal model of sleep-wake cycle is fundamental for brain development.&#xD;
&#xD;
      The objective of the research is to develop new tools for computer-aided clinical and&#xD;
      predictive diagnosis and real-time monitoring in neonatology.&#xD;
&#xD;
      The development of non-invasive sensors based on video and sound images aims to improve the&#xD;
      short- and medium-term prognosis in perinatal patients.&#xD;
&#xD;
      To that aim, multi-modal composite indices integrating the image (which is used only to&#xD;
      generate a quantification of the movement) and the sound to the bioelectric signals already&#xD;
      available (electrocardiogram, oxymetry, temperature) will be developed to provide diagnostic&#xD;
      and prognostic information.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 17, 2015</start_date>
  <completion_date type="Actual">October 26, 2016</completion_date>
  <primary_completion_date type="Actual">October 26, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evolution of the cardiac variability during the stay in the ward</measure>
    <time_frame>Up to 2 months</time_frame>
    <description>The cardiac signals collected by the clinical monitoring required for hospitalization in a neonatal unit will be analyzed by specific routines to calculate parameters of cardiac variability.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evolution of the respiratory variability during the stay in the ward</measure>
    <time_frame>Up to 2 months</time_frame>
    <description>The respiratory signals collected by the clinical monitoring required for hospitalization in a neonatal unit will be analyzed by specific routines to calculate parameters of respiratory variability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of the babies' movements during the stay in the ward</measure>
    <time_frame>Up to 2 months</time_frame>
    <description>Continuous video acquisitions of the newborns are realized. Video images will be analyzed by specific routines to extract quantitative parameters of movements.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">35</enrollment>
  <condition>Neonatal Disorder</condition>
  <arm_group>
    <arm_group_label>Neonates</arm_group_label>
    <description>Babies born in Rennes University Hospital</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data collection</intervention_name>
    <description>After parental information and collection of their non-opposition, the data of the daily cardio-respiratory recordings of the newborns hospitalized in the units of Neonatology are collected and analyzed.&#xD;
At the same time, a video recording is set up. This video recording does not modify the care provided for the child, the organization of the day with nursing and parental care.</description>
    <arm_group_label>Neonates</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This study is aimed at newborns hospitalized at the CHU in Rennes&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  newborns less than 6 weeks old in corrected terms;&#xD;
&#xD;
          -  newborns in one of the following situations:&#xD;
&#xD;
               -  persistent discomfort (apneas);&#xD;
&#xD;
               -  infection or suspicion of infection;&#xD;
&#xD;
               -  premature with uncomplicated evolution;&#xD;
&#xD;
               -  Premature brain lesion acquired in perinatal;&#xD;
&#xD;
               -  newborn having been exposed to premature rupture of the membranes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Congenital malformation;&#xD;
&#xD;
          -  Metabolic disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>6 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patrick PLADYS, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>CHU Rennes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rennes University Hospital</name>
      <address>
        <city>Rennes</city>
        <zip>35000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>October 1, 2018</last_update_submitted>
  <last_update_submitted_qc>October 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>neonates</keyword>
  <keyword>non invasive monitoring</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infant, Newborn, Diseases</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/NCT03270410
org study id: 35RC15_3012
nct id: NCT03270410
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a preliminary study whose objectives are to define the clinical use cases and the
      constraints of the implementation of a multi-sensor image-sound system.
300 000 newborns per year are hospitalized in European neonatal units in the post-natal
      period. This is a critical period for neurobehavioral development and the establishment of an
      optimal model of sleep-wake cycle is fundamental for brain development.

      The objective of the research is to develop new tools for computer-aided clinical and
      predictive diagnosis and real-time monitoring in neonatology.

      The development of non-invasive sensors based on video and sound images aims to improve the
      short- and medium-term prognosis in perinatal patients.

      To that aim, multi-modal composite indices integrating the image (which is used only to
      generate a quantification of the movement) and the sound to the bioelectric signals already
      available (electrocardiogram, oxymetry, temperature) will be developed to provide diagnostic
      and prognostic information.
observational model: Cohort
time perspective: Prospective
measure: Evolution of the cardiac variability during the stay in the ward
time frame: Up to 2 months
description: The cardiac signals collected by the clinical monitoring required for hospitalization in a neonatal unit will be analyzed by specific routines to calculate parameters of cardiac variability.
measure: Evolution of the respiratory variability during the stay in the ward
time frame: Up to 2 months
description: The respiratory signals collected by the clinical monitoring required for hospitalization in a neonatal unit will be analyzed by specific routines to calculate parameters of respiratory variability.
measure: Evolution of the babies' movements during the stay in the ward
time frame: Up to 2 months
description: Continuous video acquisitions of the newborns are realized. Video images will be analyzed by specific routines to extract quantitative parameters of movements.
arm group label: Neonates
description: Babies born in Rennes University Hospital
intervention type: Other
intervention name: Data collection
description: After parental information and collection of their non-opposition, the data of the daily cardio-respiratory recordings of the newborns hospitalized in the units of Neonatology are collected and analyzed.
At the same time, a video recording is set up. This video recording does not modify the care provided for the child, the organization of the day with nursing and parental care.
arm group label: Neonates
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 6 Weeks
healthy volunteers: No
last name: Patrick PLADYS, MD, PhD
role: Study Director
affiliation: CHU Rennes
facility: 
country: France
responsible party type: Sponsor
mesh term: Infant, Newborn, Diseases
sharing ipd: No