<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/NCT01707589</url>
  </required_header>
  <id_info>
    <org_study_id>Pediatric Elfi-Monitor</org_study_id>
    <nct_id>NCT01707589</nct_id>
  </id_info>
  <brief_title>Noninvasive Monitoring of Vital Signs in Neonates</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meir Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meir Medical Center</source>
  <brief_summary>
    <textblock>
      the investigators are assessing a non-invasive monitor based on dynamic light scattering that&#xD;
      measures pulse rate and respiration rate. The monitor also will be equipped with a&#xD;
      temperature sensor and a motion sensor. This monitor will allow multi-parametric measurements&#xD;
      in neonates in a simple and noninvasive manner.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Monitoring vital signs in neonates is important. This currently is done with multiple&#xD;
      standard clinical monitors. the investigators are developing a very small (coin-sized) sensor&#xD;
      that can measure pulse rate, respiratory rate, temperature and body motion. the investigators&#xD;
      propose to test our sensor against standard monitoring techniques in neonates in a neonatal&#xD;
      ICU (NICU).&#xD;
&#xD;
      The monitor, called ELFI-monitor, is based on dynamic light scattering. A low-power laser&#xD;
      beams light into the skin, and the red blood cells in the underlying skin return the light&#xD;
      which is recorded in a light sensor. The movement of the red blood cells is affected by the&#xD;
      rhythmic cardiac contractility. in this manner, heart rate and rhythm can be assessed. The&#xD;
      ELFI monitor also contains an embedded temperature probe and a miniature 3-D motion sensor,&#xD;
      allowing capture of additional parameters.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      the investigators plan to study 100 neonates admitted to the NICU of Meir Hospital Center.&#xD;
      These infants are routinely monitored with standard equipment including ECG, oximeter,&#xD;
      temperature, and respiratory monitors. the investigators will simultaneously monitor these&#xD;
      children with the ELFI monitor, recording pulse rate, cardiac rhythm, respiratory rate, skin&#xD;
      temperature and body motion. Recordings will be conducted for a one-hour period on each&#xD;
      subject. Data recordings from the ELFI sensor will be compared to the readouts of the&#xD;
      conventional monitors used on the patient. It is important to emphasize that the data&#xD;
      recordings of the ELFI sensor will not affect clinical decisions in any manner, but will&#xD;
      merely be recorded for comparison with conventional sensors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>May 2013</start_date>
  <primary_completion_date type="Anticipated">October 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of data collected from ELFI sensor to standard monitors</measure>
    <time_frame>6 months</time_frame>
    <description>the investigators are comparing the data recoded by the new sensor to that recorded by conventional sensors during a period of one hour in the NICU. The data recorded by the new sensor will not be used for clinical decision making.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Admission to the NICU and Need for Physiological Monitoring.</condition>
  <arm_group>
    <arm_group_label>Neonates admitted to the NICU</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neonates admitted to the NICU for a variety of medical reasons will be the cohort group. Those whose parents give informed consent will compose the subjects of the study</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>The new sensor is not on the market. We have named it Elfi-sensor.</intervention_name>
    <description>Participating subjects will be monitored for one hour with a noninvasive sensor.The noninvasive sensor, the size of a penny, will be affixed to the skin, above the umbilicus, with pediatric adhesive tape. The monitor will record continuously the heart rate, cardiac rhythm, respiratory rate and body motion.</description>
    <arm_group_label>Neonates admitted to the NICU</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All neonates admitted the Meir Hospital center NICU&#xD;
&#xD;
          -  Parents provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neonates with skin disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>6 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sofia Bauer-rosek, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Meir Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Neonatal department Meir Medical Center</name>
      <address>
        <city>Kfar Saba</city>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Sofia Bauer-rosek, MD</last_name>
      <phone>09-7471554</phone>
      <email>bauers@clalit.org.il</email>
    </contact>
    <investigator>
      <last_name>Sofia Bauer-rosek, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <link>
    <url>http://www.elfi-tech.com/</url>
    <description>Related Info</description>
  </link>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>February 11, 2013</last_update_submitted>
  <last_update_submitted_qc>February 11, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 12, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>monitoring</keyword>
  <keyword>heart rate</keyword>
  <keyword>respiration rate</keyword>
  <keyword>temperature</keyword>
  <keyword>motion</keyword>
  <keyword>noninvasive</keyword>
  <keyword>physiologic parameters</keyword>
  <keyword>NICU</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/NCT01707589
org study id: Pediatric Elfi-Monitor
nct id: NCT01707589
lead sponsor: 
the investigators are assessing a non-invasive monitor based on dynamic light scattering that
      measures pulse rate and respiration rate. The monitor also will be equipped with a
      temperature sensor and a motion sensor. This monitor will allow multi-parametric measurements
      in neonates in a simple and noninvasive manner.
Monitoring vital signs in neonates is important. This currently is done with multiple
      standard clinical monitors. the investigators are developing a very small (coin-sized) sensor
      that can measure pulse rate, respiratory rate, temperature and body motion. the investigators
      propose to test our sensor against standard monitoring techniques in neonates in a neonatal
      ICU (NICU).

      The monitor, called ELFI-monitor, is based on dynamic light scattering. A low-power laser
      beams light into the skin, and the red blood cells in the underlying skin return the light
      which is recorded in a light sensor. The movement of the red blood cells is affected by the
      rhythmic cardiac contractility. in this manner, heart rate and rhythm can be assessed. The
      ELFI monitor also contains an embedded temperature probe and a miniature 3-D motion sensor,
      allowing capture of additional parameters.

      Methods:

      the investigators plan to study 100 neonates admitted to the NICU of Meir Hospital Center.
      These infants are routinely monitored with standard equipment including ECG, oximeter,
      temperature, and respiratory monitors. the investigators will simultaneously monitor these
      children with the ELFI monitor, recording pulse rate, cardiac rhythm, respiratory rate, skin
      temperature and body motion. Recordings will be conducted for a one-hour period on each
      subject. Data recordings from the ELFI sensor will be compared to the readouts of the
      conventional monitors used on the patient. It is important to emphasize that the data
      recordings of the ELFI sensor will not affect clinical decisions in any manner, but will
      merely be recorded for comparison with conventional sensors.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Comparison of data collected from ELFI sensor to standard monitors
time frame: 6 months
description: the investigators are comparing the data recoded by the new sensor to that recorded by conventional sensors during a period of one hour in the NICU. The data recorded by the new sensor will not be used for clinical decision making.
arm group label: Neonates admitted to the NICU
arm group type: Experimental
description: Neonates admitted to the NICU for a variety of medical reasons will be the cohort group. Those whose parents give informed consent will compose the subjects of the study
intervention type: Device
intervention name: The new sensor is not on the market. We have named it Elfi-sensor.
description: Participating subjects will be monitored for one hour with a noninvasive sensor.The noninvasive sensor, the size of a penny, will be affixed to the skin, above the umbilicus, with pediatric adhesive tape. The monitor will record continuously the heart rate, cardiac rhythm, respiratory rate and body motion.
arm group label: Neonates admitted to the NICU
criteria: 
gender: All
minimum age: 1 Day
maximum age: 6 Months
healthy volunteers: No
last name: Sofia Bauer-rosek, MD
role: Principal Investigator
affiliation: Meir Medical Center
facility: 
contact: 
investigator: 
country: Israel
url: http://www.elfi-tech.com/
description: Related Info
responsible party type: Sponsor