CompletedNot Applicable

Functional Modeling of the Pediatric Airway

United States39 participantsStarted 2011-04

Plain-language 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.

Who can participate

Age range17 Years

SexALL

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Inclusion criteria

✓. Micrognathia, Suspected or Diagnosis of PRS, defined (Gorlin) as:
✓. Informed consent by parent or legal guardian
✓. Age \< 18 years at enrollment
✓. Scheduled for clinically indicated endoscopic upper airway evaluation
✓. Ability to comply with study visits and study procedures as judged by the site investigator

Exclusion criteria

✕. Acute, intercurrent respiratory infection, defined as an increase from baseline in cough, wheezing, or respiratory rate with onset in the preceding week.
✕. 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).
✕. For research CT scans any sedation risk, such as Bronchopulmonary Dysplasia (BPD) with upper airway obstruction, residual oxygen requirement, and an unsecured airway.

What they're measuring

Change in Functional computational model outcome parameters

Timeframe: years 1- 3

Trial details

NCT IDNCT01690078

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2015-08

View on ClinicalTrials.gov More Subglottic Stenosis (SGS) trials