Study to Evaluate the Efficacy of Optical Imaging to Evaluate the Anatomy of the Developing Pediatric Vocal Fold

NCT01810107 | Completed

• 1 other identifier: 11-006H
• Study Type: observational
• Target: 557
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Vocal Fold Development

Outcome Measures

Primary Outcomes (1)

• Vocal Fold Development

  The goal of this study is to identify critical periods of development when the lamina propria structure of the pediatric vocal fold matures. The major analysis will be to validate the age dependent laminar structure using a cohort of 720 subjects between age 0-18 as well as estimate the probability of future events of developing two- or three laminar structure given a subject's age. We will perform one-sided two-sample binomial tests to examine as well as model the patterns of the rates of bi- and tri-laminar structure patterns by using logistic model or discrete or continuous time Cox's proportional hazards model of which the predictor variables are determined based on the discriminant model described above. In addition, as a parallel approach we will analyze the Optical Coherence Tomography (OCT) data of each of the trilaminar system by using linear or curve-linear regression models which will provide a prediction model of the mean OCT at various critical ages.

  30 seconds to a minute, in the operating room, before the otolaryngology procedure that they are originally there for. This time frame is all that is needed to image their vocal cords.

Study Arms (2)

Children Examined with the OCT Probe

Children undergoing surgery will also have the Optical Coherence Tomography probe.

Procedure: Children Examined with the OCT Probe

Adults

Adults undergoing surgery will also have the Optical Coherence Tomography probe.

Procedure: Children Examined with the OCT Probe

Interventions

Children Examined with the OCT Probe PROCEDURE

The child undergoing therapy will have the Optical Coherence Tomography (OCT) probe to examine the vocal fold.

Adults; Children Examined with the OCT Probe

Eligibility Criteria

• Age: 1 Month - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

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.

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead

Study Sites (1)

Massachusetts Eye and Ear

Boston, Massachusetts, 02115, United States

Location

Study Officials

• Christopher Hartnick, MD

  Massachusetts Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 19, 2012
• First Posted: March 13, 2013
• Study Start: July 1, 2011
• Primary Completion: September 26, 2019
• Study Completion: December 21, 2019
• Last Updated: May 27, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)