<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/NCT04483869</url>
  </required_header>
  <id_info>
    <org_study_id>2020-A00265-34</org_study_id>
    <nct_id>NCT04483869</nct_id>
  </id_info>
  <brief_title>Infrared Thermography and Apgar Score</brief_title>
  <acronym>VIRGINA</acronym>
  <official_title>Infrared Thermography and Apgar Score: Evaluation in Delivery Room for Term Newborn</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poissy-Saint Germain Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Poissy-Saint Germain 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>
      Background: The Apgar score assesses the newborn's adaptation in the first minutes of life.&#xD;
      It is rated between 0 and 10 by the midwife, at 1-3-5 and 10 minutes of life. A low Apgar&#xD;
      score at 5 minutes of life is associated with increased neonatal mortality and neurological&#xD;
      impairment. However, this score has limitations and its measurement remains subjective: it&#xD;
      does not guide resuscitation actions in the event of poor adaptation, significant&#xD;
      inter-observer variability in scoring, variations according to the physiological maturation&#xD;
      of the newborn, in particular according to gestational age.&#xD;
&#xD;
      Infrared thermography is a rapidly developing imaging technique based on the measurement of&#xD;
      infrared radiation. It is an accurate, reliable and easy instrument of providing rapid&#xD;
      non-contact, non-invasive and non-irradiating diagnosis. A recent 2018 study showed that the&#xD;
      use of thermography would allow accurate and non-invasive monitoring of newborns in neonatal&#xD;
      intensive care unit for early diagnosis of certain pathologies such as infection. During the&#xD;
      transition, during the first minutes of life, the circulatory and respiratory systems of the&#xD;
      newborn change. Vasodilatation occurs progressively in the central and peripheral areas.&#xD;
      Thermoregulation is also a crucial stage of adaptation.&#xD;
&#xD;
      In view of this physiopathological knowledge, it seems interesting to correlate this&#xD;
      adaptation , with the analysis of thermographic images. The principle of this technique is&#xD;
      indeed based on the analysis of the heat emitted, and would thus make it possible to evaluate&#xD;
      the blood perfusion of the newborn, and its evolution in the first minutes of life in an&#xD;
      objective way. Our hypothesis is that a poor adaptation could be detected more efficiently on&#xD;
      photographs taken at time T, contrary to the calculation of the Apgar score for which there&#xD;
      are several limitations mentioned above.&#xD;
&#xD;
      Main objective of the study: To study the ability of the thermographic image to objectively&#xD;
      evaluate the adaptation to ectopic life of newborns compared to existing evaluations (Apgar,&#xD;
      pH, Lactates).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 23, 2020</start_date>
  <completion_date type="Anticipated">July 2022</completion_date>
  <primary_completion_date type="Actual">July 23, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>thermographic image</measure>
    <time_frame>1 minute of life</time_frame>
    <description>Correlation between thermographic image and Apgar score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>thermographic image</measure>
    <time_frame>5 minutes of life</time_frame>
    <description>Correlation between thermographic image and Apgar score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>thermographic image</measure>
    <time_frame>10 minutes of life</time_frame>
    <description>Correlation between thermographic image and Apgar score</description>
  </primary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Newborn, Transient</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Thermography</intervention_name>
    <description>thermographic image a 1, 3, 5 et 10 minutes of life</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Term newborn, born after cesarean delivery, without congenital anomalies&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  term infants, gestational age ≥ 37 weeks of gestation&#xD;
&#xD;
          -  cesarean delivery&#xD;
&#xD;
          -  maternal age ≥ 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  parents refusal&#xD;
&#xD;
          -  congenital anomalies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>15 Minutes</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Poissy Saint Germain Hospital</name>
      <address>
        <city>Poissy</city>
        <zip>78300</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mathilde P. Letouzey, MD</last_name>
      <phone>+33139274430</phone>
      <email>mathilde.letouzey@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 23, 2020</last_update_submitted>
  <last_update_submitted_qc>July 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Poissy-Saint Germain Hospital</investigator_affiliation>
    <investigator_full_name>Mathilde Letouzey, MD</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>thermography</keyword>
  <keyword>apgar score</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04483869
org study id: 2020-A00265-34
nct id: NCT04483869
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: The Apgar score assesses the newborn's adaptation in the first minutes of life.
      It is rated between 0 and 10 by the midwife, at 1-3-5 and 10 minutes of life. A low Apgar
      score at 5 minutes of life is associated with increased neonatal mortality and neurological
      impairment. However, this score has limitations and its measurement remains subjective: it
      does not guide resuscitation actions in the event of poor adaptation, significant
      inter-observer variability in scoring, variations according to the physiological maturation
      of the newborn, in particular according to gestational age.

      Infrared thermography is a rapidly developing imaging technique based on the measurement of
      infrared radiation. It is an accurate, reliable and easy instrument of providing rapid
      non-contact, non-invasive and non-irradiating diagnosis. A recent 2018 study showed that the
      use of thermography would allow accurate and non-invasive monitoring of newborns in neonatal
      intensive care unit for early diagnosis of certain pathologies such as infection. During the
      transition, during the first minutes of life, the circulatory and respiratory systems of the
      newborn change. Vasodilatation occurs progressively in the central and peripheral areas.
      Thermoregulation is also a crucial stage of adaptation.

      In view of this physiopathological knowledge, it seems interesting to correlate this
      adaptation , with the analysis of thermographic images. The principle of this technique is
      indeed based on the analysis of the heat emitted, and would thus make it possible to evaluate
      the blood perfusion of the newborn, and its evolution in the first minutes of life in an
      objective way. Our hypothesis is that a poor adaptation could be detected more efficiently on
      photographs taken at time T, contrary to the calculation of the Apgar score for which there
      are several limitations mentioned above.

      Main objective of the study: To study the ability of the thermographic image to objectively
      evaluate the adaptation to ectopic life of newborns compared to existing evaluations (Apgar,
      pH, Lactates).
observational model: Other
time perspective: Cross-Sectional
measure: thermographic image
time frame: 1 minute of life
description: Correlation between thermographic image and Apgar score
measure: thermographic image
time frame: 5 minutes of life
description: Correlation between thermographic image and Apgar score
measure: thermographic image
time frame: 10 minutes of life
description: Correlation between thermographic image and Apgar score
intervention type: Other
intervention name: Thermography
description: thermographic image a 1, 3, 5 et 10 minutes of life
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 15 Minutes
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Poissy-Saint Germain Hospital
investigator full name: Mathilde Letouzey, MD
investigator title: Principal investigator
sharing ipd: Undecided