Functional Modeling of the Pediatric Airway
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|ClinicalTrials.gov Identifier: NCT01690078|
Recruitment Status : Completed
First Posted : September 21, 2012
Last Update Posted : April 20, 2017
|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|
|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 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.
- 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)
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01690078
|United States, North Carolina|
|North Carolina Children's Hospital|
|Chapel Hill, North Carolina, United States, 27514|
|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|