Status:
COMPLETED
Study to Evaluate the Efficacy of Optical Imaging to Evaluate the Anatomy of the Developing Pediatric Vocal Fold
Lead Sponsor:
Massachusetts Eye and Ear Infirmary
Conditions:
Vocal Fold Development
Eligibility:
All Genders
1-99 years
Brief Summary
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 la...
Detailed Description
The goal of this study is to identify critical periods of development when the lamina propria structure of the pediatric vocal fold matures. A Universal Modular Glottiscope will be utilized for adequa...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 21 2019
Estimated Enrollment :
557 Patients enrolled
Trial Details
Trial ID
NCT01810107
Start Date
July 1 2011
End Date
December 21 2019
Last Update
May 27 2020
Active Locations (1)
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1
Massachusetts Eye and Ear
Boston, Massachusetts, United States, 02115