<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/NCT03241082</url>
  </required_header>
  <id_info>
    <org_study_id>PEDS-2017-25699</org_study_id>
    <nct_id>NCT03241082</nct_id>
  </id_info>
  <brief_title>Ultrasound Assessment of BC in the NICU</brief_title>
  <official_title>Use of Bedside Ultrasound to Assess Neonatal Body Composition in the Neonatal Intensive Care Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</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>
      The overall objective of the proposal is to evaluate the ability of ultrasound to predict and&#xD;
      routinely (weekly) monitor changes in the body composition of healthy preterm infants in the&#xD;
      neonatal intensive care unit (NICU) in response to nutritional intake. The investigators&#xD;
      hypothesize that ultrasound is an accurate method to routinely monitor the quality of weight&#xD;
      gain and assess the adequacy of nutritional provision for premature infants in the neonatal&#xD;
      intensive care unit.&#xD;
&#xD;
      The investigators will address the hypothesis in the following Specific Aims:&#xD;
&#xD;
      Specific Aim 1: Validate ultrasound as a method to measure whole body fat mass and fat free&#xD;
      mass in healthy, premature infants. Body composition will be assessed using ultrasound&#xD;
      measurements and the validated method of air displacement plethysmography (ADP). Stable&#xD;
      isotope dilution techniques will be used in a subset of our population as a secondary source&#xD;
      of validation.&#xD;
&#xD;
      Specific Aim 2: Determine whether ultrasound measurements can detect clinically relevant&#xD;
      (weekly) changes in body composition in healthy premature infants. Ultrasound will be used to&#xD;
      obtain serial (weekly) measurements of muscle and adipose tissue thickness (triceps, abdomen,&#xD;
      quadriceps) until discharge in healthy, premature infants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 23, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Actual">January 31, 2022</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>Whole-body measurements of body composition</measure>
    <time_frame>Up to 6 weeks</time_frame>
    <description>Measurement of whole body fat mass and fat-free mass via air displacement plethysmography and stable isotope dilution.</description>
  </primary_outcome>
  <enrollment type="Actual">68</enrollment>
  <condition>Premature Infant</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ultrasound</intervention_name>
    <description>validation of portable ultrasound to measure body composition</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Infants admitted to the University of Minnesota NICU under the care of the PI and/or her&#xD;
        colleagues.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy, premature infants 25-34+6 weeks gestational age at birth&#xD;
&#xD;
          -  Admitted to the University of Minnesota Masonic Children's Hospital NICU&#xD;
&#xD;
          -  Stable on room air or can be removed from respiratory support for 5 minutes&#xD;
&#xD;
          -  Written or verbal (telephone) informed consent can be secured from a parent within 1&#xD;
             week of admission to the NICU&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -Require medical support preventing ADP measurements&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Weeks</minimum_age>
    <maximum_age>34 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sara Ramel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota Department of Pediatrics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Minnesota Masonic Children's Hospital</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>March 6, 2023</last_update_submitted>
  <last_update_submitted_qc>March 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03241082
org study id: PEDS-2017-25699
nct id: NCT03241082
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overall objective of the proposal is to evaluate the ability of ultrasound to predict and
      routinely (weekly) monitor changes in the body composition of healthy preterm infants in the
      neonatal intensive care unit (NICU) in response to nutritional intake. The investigators
      hypothesize that ultrasound is an accurate method to routinely monitor the quality of weight
      gain and assess the adequacy of nutritional provision for premature infants in the neonatal
      intensive care unit.

      The investigators will address the hypothesis in the following Specific Aims:

      Specific Aim 1: Validate ultrasound as a method to measure whole body fat mass and fat free
      mass in healthy, premature infants. Body composition will be assessed using ultrasound
      measurements and the validated method of air displacement plethysmography (ADP). Stable
      isotope dilution techniques will be used in a subset of our population as a secondary source
      of validation.

      Specific Aim 2: Determine whether ultrasound measurements can detect clinically relevant
      (weekly) changes in body composition in healthy premature infants. Ultrasound will be used to
      obtain serial (weekly) measurements of muscle and adipose tissue thickness (triceps, abdomen,
      quadriceps) until discharge in healthy, premature infants.
observational model: Cohort
time perspective: Prospective
measure: Whole-body measurements of body composition
time frame: Up to 6 weeks
description: Measurement of whole body fat mass and fat-free mass via air displacement plethysmography and stable isotope dilution.
intervention type: Device
intervention name: ultrasound
description: validation of portable ultrasound to measure body composition
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 25 Weeks
maximum age: 34 Weeks
healthy volunteers: No
last name: Sara Ramel, MD
role: Principal Investigator
affiliation: University of Minnesota Department of Pediatrics
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Undecided