Micrognathia Clinical Trial
Official title:
Predictive Modeling for Treatment of Upper Airway Obstruction in Young Children
| Verified date | June 2016 |
| Source | University of North Carolina, Chapel Hill |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 39 |
| Est. completion date | August 2015 |
| Est. primary completion date | August 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 17 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | North Carolina Children's Hospital | Chapel Hill | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| University of North Carolina, Chapel Hill | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
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.
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. — View 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).
Mitran S. Continuum-kinetic-microscopic model of lung clearance due to core-annular fluid entrainment. J Comput Phys. 2013 Jul 1;244:193-211. — View Citation
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.
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Functional computational model outcome parameters | 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) | years 1- 3 | |
| Secondary | Validation of Computational model | 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. | year 4 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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