Functional Modeling of the Pediatric Airway

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01690078
Recruitment Status : Completed
First Posted : September 21, 2012
Last Update Posted : April 20, 2017
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
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.

Condition or disease
Subglottic Stenosis (SGS) Pierre Robin Sequence (PRS) Micrognathia Normal Controls From CT Scans of the Upper Airway

Study Type : Observational
Actual Enrollment : 39 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictive Modeling for Treatment of Upper Airway Obstruction in Young Children
Study Start Date : April 2011
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Cross sectional
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.
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.
Normal Control Data
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.

Primary Outcome Measures :
  1. Change in Functional computational model outcome parameters [ Time Frame: years 1- 3 ]
    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)

Secondary Outcome Measures :
  1. Validation of Computational model [ Time Frame: year 4 ]
    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.

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children < 18 years of age with a diagnosis of either Pierre Robin Sequence, Micrognathia or Subglottic Stenosis.

Clinically indicated control data will be collected from CT scans of neck and maxillofacial CT scans performed on children < 18 years of age


Inclusion Criteria:

  1. Micrognathia, Suspected or Diagnosis of PRS, defined (Gorlin) as:

    micrognathia (mandibular hypoplasia), cleft palate and airway obstruction, and/or

    Diagnosis of SGS defined (Bluestone) as:

    • subglottic airway diameter of 4 mm or less in a term neonate;
    • subglottic airway diameter of 3.5 mm or less in a premature neonate;
    • inability to pass an endotracheal tube of expected size for age
  2. Informed consent by parent or legal guardian
  3. Age < 18 years at enrollment
  4. Scheduled for clinically indicated endoscopic upper airway evaluation
  5. Ability to comply with study visits and study procedures as judged by the site investigator

Inclusion criterion also included for Specific Aim 2 (Longitudinal):

Subjects must be scheduled for an operative procedure to correct or bypass upper airway obstruction (i.e. mandibular distraction, endoscopic airway surgery, laryngotracheoplasty, cricotracheal resection, or tracheostomy) OR recently (within past 4 weeks) diagnosed as having an anomaly not currently requiring surgical management.

Exclusion Criteria:

  1. Acute, intercurrent respiratory infection, defined as an increase from baseline in cough, wheezing, or respiratory rate with onset in the preceding week.
  2. Physical findings at screening that would compromise the safety of the participant or the quality of the study (i.e. fever, increased respiratory rate above baseline, significant acute emesis, or alteration in baseline neurologic status).
  3. For research CT scans any sedation risk, such as Bronchopulmonary Dysplasia (BPD) with upper airway obstruction, residual oxygen requirement, and an unsecured airway.

Control data will be collected from clinically indicated neck or maxillofacial CT imaging data that include the entire airway with no noted airway obstructions or airway abnormalities.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01690078

United States, North Carolina
North Carolina Children's Hospital
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Stephanie D Davis, MD Indiana University School of Medicine
Principal Investigator: Carlton Zdanski, MD University of North Carolina, Chapel Hill
Principal Investigator: Richard Superfine, PhD University of North Carolina, Chapel Hill

Calloway, E.H., Kimbell, J.S., Davis, S.D., Retsch-Bogart, G.Z., Pitkin, E.A., Abode, K., Superfine, R.,and Zdanski, C.J. (2012). Comparison of Endoscopic versus 3D CT Derived Airway Measurements. Podium presentation, The Triological, Society Combined Otolaryngological Spring Meetings, San Diego, CA, USA, April 18-22, 2012, Submitted to The Laryngoscope, 3/26/2012.
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).
Mitran, S. (2012b), "Lattice Fokker-Planck Method Based on Wasserstein Gradient Flows", Phys. Rev.E., (under review).
Oluwafemi S. Alabi, Xunlei Wu, Steffen Bass, Scott Pratt, Sharon Zhong, Chris Healey, Russell M.Taylor II, "Exploring Ensemble Data Sets Through Ensemble Surface Slicing," Proceedings of SPIEVisualization and Data Analysis 2012. Proceedings of the SPIE, Volume 8294, pp. U1-U12.
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.
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: University of North Carolina, Chapel Hill Identifier: NCT01690078     History of Changes
Other Study ID Numbers: 10-1634
R01HL105241 ( U.S. NIH Grant/Contract )
First Posted: September 21, 2012    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: June 2016

Keywords provided by University of North Carolina, Chapel Hill:
Airway modeling
Pierre Robin Sequence or PRS
Subglottic Stenosis or SGS

Additional relevant MeSH terms:
Pierre Robin Syndrome
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiratory System Abnormalities