<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/NCT01690078</url>
  </required_header>
  <id_info>
    <org_study_id>10-1634</org_study_id>
    <secondary_id>R01HL105241</secondary_id>
    <nct_id>NCT01690078</nct_id>
  </id_info>
  <brief_title>Functional Modeling of the Pediatric Airway</brief_title>
  <official_title>Predictive Modeling for Treatment of Upper Airway Obstruction in Young Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesize that a functional computational model that simulates the&#xD;
      mechanical and aerodynamic behavior of the upper airway in children with Pierre Robin&#xD;
      Sequence (PRS) and laryngeal lesions (e.g. subglottic stenosis or SGS) can be used as an&#xD;
      effective diagnostic and treatment planning tool.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2011</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</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>Change in Functional computational model outcome parameters</measure>
    <time_frame>years 1- 3</time_frame>
    <description>Change in functional computational modeling parameters as compared to the change in percent of total time spent with oxygen saturation &lt; 90% as noted on polysomnogram (physiologic measure) and change in airway measurements obtained via clinically indicated upper airway endoscopy (anatomic measure) pre and post-intervention(medical or surgical)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Validation of Computational model</measure>
    <time_frame>year 4</time_frame>
    <description>Apply the computational model to infants and children being evaluated for Pierre Robin Sequence and Subglottic Stenosis, to determine the ability of the model to accurately predict the results of various potential interventions on anatomic and physiologic metrics.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">39</enrollment>
  <condition>Subglottic Stenosis (SGS)</condition>
  <condition>Pierre Robin Sequence (PRS)</condition>
  <condition>Micrognathia</condition>
  <condition>Normal Controls From CT Scans of the Upper Airway</condition>
  <arm_group>
    <arm_group_label>Cross sectional</arm_group_label>
    <description>Cross sectional study where subjects with PRS, micrognathia, or SGS will have a single study visit that will be scheduled within 14 days of a clinically indicated upper airway endoscopy. CT scans of the neck or maxillofacial CT will be obtained in all subjects. During upper airway endoscopy, airway measurements will be conducted. Cohort may include subjects who have previously undergone medical or surgical intervention for their airway obstruction, or who are currently undergoing multidisciplinary team management. The following data will be collected: clinical parameters, Obstructive Sleep Apnea (OSA)OSA-18 (quality of life) questionnaire, and lung function tests (subjects &gt; 4 years of age). Clinically indicated swallowing studies and voice evaluations will be collected.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Longitudinal</arm_group_label>
    <description>The prospective, longitudinal cohort arm of the study is designed to describe the effects of treatment on clinical and computational model endpoints. This is performed in a subset of subjects with PRS, micrognathia, or SGS who are scheduled for clinically indicated upper airway endoscopy and who are scheduled to complete a definitive treatment course which necessitates multiple endoscopic evaluations and follow-up imaging. Subjects will have an entry visit comparable to the cross-sectional entry visit. Longitudinal subjects will have up to 3 additional study visits over a 12 to 15-month period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal Control Data</arm_group_label>
    <description>Normal de-identified control data is retrospectively collected from clinically indicated CT scans of the neck and maxillofacial CT scans in children less than 18 years of age.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Children &lt; 18 years of age with a diagnosis of either Pierre Robin Sequence, Micrognathia&#xD;
        or Subglottic Stenosis.&#xD;
&#xD;
        Clinically indicated control data will be collected from CT scans of neck and maxillofacial&#xD;
        CT scans performed on children &lt; 18 years of age&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Micrognathia, Suspected or Diagnosis of PRS, defined (Gorlin) as:&#xD;
&#xD;
             micrognathia (mandibular hypoplasia), cleft palate and airway obstruction, and/or&#xD;
&#xD;
             Diagnosis of SGS defined (Bluestone) as:&#xD;
&#xD;
               -  subglottic airway diameter of 4 mm or less in a term neonate;&#xD;
&#xD;
               -  subglottic airway diameter of 3.5 mm or less in a premature neonate;&#xD;
&#xD;
               -  inability to pass an endotracheal tube of expected size for age&#xD;
&#xD;
          2. Informed consent by parent or legal guardian&#xD;
&#xD;
          3. Age &lt; 18 years at enrollment&#xD;
&#xD;
          4. Scheduled for clinically indicated endoscopic upper airway evaluation&#xD;
&#xD;
          5. Ability to comply with study visits and study procedures as judged by the site&#xD;
             investigator&#xD;
&#xD;
        Inclusion criterion also included for Specific Aim 2 (Longitudinal):&#xD;
&#xD;
        Subjects must be scheduled for an operative procedure to correct or bypass upper airway&#xD;
        obstruction (i.e. mandibular distraction, endoscopic airway surgery, laryngotracheoplasty,&#xD;
        cricotracheal resection, or tracheostomy) OR recently (within past 4 weeks) diagnosed as&#xD;
        having an anomaly not currently requiring surgical management.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Acute, intercurrent respiratory infection, defined as an increase from baseline in&#xD;
             cough, wheezing, or respiratory rate with onset in the preceding week.&#xD;
&#xD;
          2. Physical findings at screening that would compromise the safety of the participant or&#xD;
             the quality of the study (i.e. fever, increased respiratory rate above baseline,&#xD;
             significant acute emesis, or alteration in baseline neurologic status).&#xD;
&#xD;
          3. For research CT scans any sedation risk, such as Bronchopulmonary Dysplasia (BPD) with&#xD;
             upper airway obstruction, residual oxygen requirement, and an unsecured airway.&#xD;
&#xD;
        Control data will be collected from clinically indicated neck or maxillofacial CT imaging&#xD;
        data that include the entire airway with no noted airway obstructions or airway&#xD;
        abnormalities.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephanie D Davis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carlton Zdanski, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Richard Superfine, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>North Carolina Children's Hospital</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Calloway HE, Kimbell JS, Davis SD, Retsch-Bogart GZ, Pitkin EA, Abode K, Superfine R, Zdanski CJ. Comparison of endoscopic versus 3D CT derived airway measurements. Laryngoscope. 2013 Sep;123(9):2136-41. doi: 10.1002/lary.23836.</citation>
    <PMID>24167819</PMID>
  </reference>
  <reference>
    <citation>Mitran S. Continuum-kinetic-microscopic model of lung clearance due to core-annular fluid entrainment. J Comput Phys. 2013 Jul 1;244:193-211. doi: 10.1016/j.jcp.2013.01.037.</citation>
    <PMID>23729842</PMID>
  </reference>
  <reference>
    <citation>Mitran (2012c), Predictive Modeling of Upper Airway Flow in Young Children, Proceedings, 34th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC'12), San Diego, CA, (accepted).</citation>
  </reference>
  <reference>
    <citation>Mitran, S. (2012b), &quot;Lattice Fokker-Planck Method Based on Wasserstein Gradient Flows&quot;, Phys. Rev.E., (under review).</citation>
  </reference>
  <reference>
    <citation>Alabi OS, Wu X, Harter JM, Phadke M, Pinto L, Petersen H, Bass S, Keifer M, Zhong S, Healey C, Taylor RM 2nd. Comparative Visualization of Ensembles Using Ensemble Surface Slicing. Proc SPIE Int Soc Opt Eng. 2012 Jan 22;8294:82940U. doi: 10.1117/12.908288.</citation>
    <PMID>23560167</PMID>
  </reference>
  <reference>
    <citation>Yi Hong, Yundi Shi, Martin Styner, Mar Sanchez, and Marc Niethammer. Simple Geodesic Regression for Image Time-Series. Accepted to the 5th Workshop on Biomedical Image Registration. 2012.</citation>
  </reference>
  <reference>
    <citation>Hong Y, Joshi S, Sanchez M, Styner M, Niethammer M. Metamorphic geodesic regression. Med Image Comput Comput Assist Interv. 2012;15(Pt 3):197-205. doi: 10.1007/978-3-642-33454-2_25.</citation>
    <PMID>23286131</PMID>
  </reference>
  <reference>
    <citation>Zdanski, C., Kimbell, J.S., Superfine, R.S., and Davis, S. (2012). Computational Fluid Dynamics Modeling of the Pediatric Airway Utilizing Computed Tomography in Children with Pierre Robin Sequence. Poster presentation, European Society of Pediatric Otolaryngology, Amsterdam, The Netherlands, May 20-23, 2012.</citation>
  </reference>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>July 30, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>April 18, 2017</last_update_submitted>
  <last_update_submitted_qc>April 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Airway modeling</keyword>
  <keyword>Pierre Robin Sequence or PRS</keyword>
  <keyword>Micrognathia</keyword>
  <keyword>Subglottic Stenosis or SGS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pierre Robin Syndrome</mesh_term>
    <mesh_term>Micrognathism</mesh_term>
  </condition_browse>
  <!-- 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/NCT01690078
org study id: 10-1634
secondary id: R01HL105241
nct id: NCT01690078
lead sponsor: 
collaborator: 
has dmc: Yes
The investigators hypothesize that a functional computational model that simulates the
      mechanical and aerodynamic behavior of the upper airway in children with Pierre Robin
      Sequence (PRS) and laryngeal lesions (e.g. subglottic stenosis or SGS) can be used as an
      effective diagnostic and treatment planning tool.
observational model: Cohort
time perspective: Prospective
measure: Change in Functional computational model outcome parameters
time frame: years 1- 3
description: Change in functional computational modeling parameters as compared to the change in percent of total time spent with oxygen saturation < 90% as noted on polysomnogram (physiologic measure) and change in airway measurements obtained via clinically indicated upper airway endoscopy (anatomic measure) pre and post-intervention(medical or surgical)
measure: Validation of Computational model
time frame: year 4
description: Apply the computational model to infants and children being evaluated for Pierre Robin Sequence and Subglottic Stenosis, to determine the ability of the model to accurately predict the results of various potential interventions on anatomic and physiologic metrics.
arm group label: Cross sectional
description: Cross sectional study where subjects with PRS, micrognathia, or SGS will have a single study visit that will be scheduled within 14 days of a clinically indicated upper airway endoscopy. CT scans of the neck or maxillofacial CT will be obtained in all subjects. During upper airway endoscopy, airway measurements will be conducted. Cohort may include subjects who have previously undergone medical or surgical intervention for their airway obstruction, or who are currently undergoing multidisciplinary team management. The following data will be collected: clinical parameters, Obstructive Sleep Apnea (OSA)OSA-18 (quality of life) questionnaire, and lung function tests (subjects > 4 years of age). Clinically indicated swallowing studies and voice evaluations will be collected.
arm group label: Longitudinal
description: The prospective, longitudinal cohort arm of the study is designed to describe the effects of treatment on clinical and computational model endpoints. This is performed in a subset of subjects with PRS, micrognathia, or SGS who are scheduled for clinically indicated upper airway endoscopy and who are scheduled to complete a definitive treatment course which necessitates multiple endoscopic evaluations and follow-up imaging. Subjects will have an entry visit comparable to the cross-sectional entry visit. Longitudinal subjects will have up to 3 additional study visits over a 12 to 15-month period.
arm group label: Normal Control Data
description: Normal de-identified control data is retrospectively collected from clinically indicated CT scans of the neck and maxillofacial CT scans in children less than 18 years of age.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 17 Years
healthy volunteers: No
last name: Stephanie D Davis, MD
role: Principal Investigator
affiliation: Indiana University School of Medicine
last name: Carlton Zdanski, MD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
last name: Richard Superfine, PhD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
citation: Calloway HE, Kimbell JS, Davis SD, Retsch-Bogart GZ, Pitkin EA, Abode K, Superfine R, Zdanski CJ. Comparison of endoscopic versus 3D CT derived airway measurements. Laryngoscope. 2013 Sep;123(9):2136-41. doi: 10.1002/lary.23836.
PMID: 24167819
citation: Mitran S. Continuum-kinetic-microscopic model of lung clearance due to core-annular fluid entrainment. J Comput Phys. 2013 Jul 1;244:193-211. doi: 10.1016/j.jcp.2013.01.037.
PMID: 23729842
citation: Mitran (2012c), Predictive Modeling of Upper Airway Flow in Young Children, Proceedings, 34th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC'12), San Diego, CA, (accepted).
citation: Mitran, S. (2012b), "Lattice Fokker-Planck Method Based on Wasserstein Gradient Flows", Phys. Rev.E., (under review).
citation: Alabi OS, Wu X, Harter JM, Phadke M, Pinto L, Petersen H, Bass S, Keifer M, Zhong S, Healey C, Taylor RM 2nd. Comparative Visualization of Ensembles Using Ensemble Surface Slicing. Proc SPIE Int Soc Opt Eng. 2012 Jan 22;8294:82940U. doi: 10.1117/12.908288.
PMID: 23560167
citation: Yi Hong, Yundi Shi, Martin Styner, Mar Sanchez, and Marc Niethammer. Simple Geodesic Regression for Image Time-Series. Accepted to the 5th Workshop on Biomedical Image Registration. 2012.
citation: Hong Y, Joshi S, Sanchez M, Styner M, Niethammer M. Metamorphic geodesic regression. Med Image Comput Comput Assist Interv. 2012;15(Pt 3):197-205. doi: 10.1007/978-3-642-33454-2_25.
PMID: 23286131
citation: Zdanski, C., Kimbell, J.S., Superfine, R.S., and Davis, S. (2012). Computational Fluid Dynamics Modeling of the Pediatric Airway Utilizing Computed Tomography in Children with Pierre Robin Sequence. Poster presentation, European Society of Pediatric Otolaryngology, Amsterdam, The Netherlands, May 20-23, 2012.
responsible party type: Sponsor
mesh term: Pierre Robin Syndrome
mesh term: Micrognathism