Clinical trial NCT01690078: Functional Modeling of the Pediatric Airway
Official title: Predictive Modeling for Treatment of Upper Airway Obstruction in Young Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subglottic Stenosis (SGS)
Pierre Robin Sequence (PRS)
Micrognathia
Normal Controls From CT Scans of the Upper Airway
Keywords: Airway modeling
Pierre Robin Sequence or PRS
Micrognathia
Subglottic Stenosis or SGS
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2012-09-21
Enrollment: 39
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Functional computational model outcome parameters
timeFrame: years 1- 3
Secondary outcomes:
measure: Validation of Computational model
timeFrame: year 4
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: North Carolina Children's Hospital
state: North Carolina
Study officials:
affiliation: Indiana University School of Medicine
name: Stephanie D Davis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Carlton Zdanski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Richard Superfine, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: 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.
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.
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.