Study to Evaluate the Efficacy of Optical Imaging to Evaluate the Anatomy of the Developing Pediatric Vocal Fold
Completed
Conditions studied: Vocal Fold Development
In brief
The specific aim of this study is to develop a growth and development chart (similar to a height or weight chart for children) that identifies the pattern of development of the pediatric vocal cord lamina propria from a single to a three layer structure. A secondary aim is to identify whether this growth chart shows a pattern of linear development or whether there are clear critical periods of development.
Key facts
- Study ID
- NCT01810107
- Run by
- Massachusetts Eye and Ear Infirmary
- People needed
- 557
- Starts
- 2011-07-01
- Expected to finish
- 2019-12-21
- Last updated by the study team
- 2020-05-27
Who can join
Age: 0 and older, up to 99. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Children ages 1 month to 18 (and adults >18) undergoing laryngoscopy and bronchoscopy for airway evaluation where the patients will be already scheduled for general anesthesia with intravenous catheter placement as part of standard routine.
- Children (and adults) undergoing any otolaryngology procedure where there is no indication of airway obstruction or risk of abnormal vocal chords. For instance, children undergoing adenoidectomy, sinus surgery or tracheotomy are all good candidates for studying the normal vocal chord development.
- Children whose parents have given and signed an informed consent and Health Insurance Portability and Accountability Act (HIPAA) Authorization and who have signed an assent form (if they are 7 and older) agreeing to participate in the study. Eligibility will be determined by the Principal Investigator.
- Adults who have given and signed an informed consent and HIPAA Authorization.
You may not qualify if…
- Children (or adults) with any form of laryngeal anomaly or pathology.
- Children who have previously been intubated.
- Children, adolescents, and adults who smoke. Exclusion will be determined by the Principal Investigator.
Where it is running
- Massachusetts Eye and Ear — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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